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The 2006 Supplier Directory - Orthoworld

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A Knowledge Enterprises, Inc. Publication<br />

www.orthosupplier.com<br />

BONEZone® Strategic Sourcing for the Orthopaedic Industry<br />

Strategic Sourcing for the Orthopaedic Industry<br />

Volume 4 Issue 4<br />

Winter 2005<br />

<strong>The</strong> <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong>


Editor’s<br />

Corner<br />

Jack Detweiler<br />

Editor<br />

Vice President<br />

Knowledge Enterprises, Inc.<br />

<strong>The</strong> <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

In 2005, 50 new <strong>Supplier</strong>s appeared in Ortho<strong>Supplier</strong> (see www.orthosupplier.com), bringing the total to<br />

225 <strong>Supplier</strong>s and Consultants that have Members in the Institute for Orthopaedics. Be sure to check<br />

out their profiles in this issue. Sixty suppliers have already committed to making themselves available to<br />

meet with you at OMTEC <strong>2006</strong> next June. A complete list of exhibitors will appear in the next issue.<br />

<strong>The</strong> Big Picture<br />

John Engelhardt, Chief Executive Officer of Knowledge Enterprises Inc., summarizes the evolution of<br />

OEM/<strong>Supplier</strong> relationships through the past decade and suggests that recent history could portend future<br />

developments.<br />

Product Development<br />

Whether for showing proof of concept, assessing or validating user requirements or system specifications,<br />

training users or exploring design problem solutions, Larry James of New Concepts Prototyping avows the<br />

value of iterative prototyping—before, during and after the beginning, middle and latter stages of development.<br />

Susan Capps summarizes the design considerations for several categories of spinal repair devices, the reasons<br />

for their use and the biomechanical considerations that drive the design parameters of each.<br />

Logistics<br />

Barbara Lyons of Precimed reassures us that RFID is no longer a pie-in-the-sky concept within our industry.<br />

<strong>The</strong> use of RFID may have more positive implications—both direct and indirect—than many of us have<br />

imagined, and its benefits are being employed and enjoyed “here and now” to the benefit of patient, surgeon,<br />

hospital and OEM alike.<br />

Technology<br />

Have no fear—OEMs can do it. Neil Ryall of Kays Engineering suggests that, owing to the high costs associated<br />

with contract manufacturing services and with the procurement of cannulated raw materials, OEMs<br />

may find value in incorporating gundrilling as one of their in-house manufacturing processes.<br />

Similarly, Kyle Elmblad of Hammond Roto-Finish proposes that mass finishing processes—in some quarters<br />

perhaps unrecognized and undervalued as being applicable to the finishing of orthopaedic implants—<br />

deserve more than cursory acknowledgement when pursuing product improvement in terms of appearance<br />

and function.<br />

Tom Neuenschwander of LH Industries Corp. highlights a 3D stamping technology that is purported to<br />

offer medical design engineers a geometric freedom that was previously unattainable. Apparently, the fundamental<br />

geometric rules of lamination stamping have changed and now offer new opportunities for application<br />

in the manufacture of medical devices.<br />

Tom Whitton of Advanced Powders and Coatings touts plasma atomization as a process that offers superior<br />

performance levels for production of titanium powder used in metal injection molding applications. <strong>The</strong><br />

sphericity and purity characteristics of powders created by this process reportedly generate a more favorable<br />

response to the demands posed by our industry.<br />

Testing<br />

Jennifer Robertson of Polymer Solutions describes a testing protocol designed to examine the interaction<br />

between bone cement and cement mixers, with the intent of determining whether the use of a particular<br />

mixer has any effect on a broad range of bone cement properties.<br />

BONEZone® is published quarterly in March, June, September and December by Knowledge Enterprises, Inc.,<br />

147 Bell Street, Suite 303, Chagrin Falls, Ohio 44022 USA. Telephone 440-247-9051. Fax 440-247-9053.<br />

Subscriptions are provided at no charge to qualified applicants with outsourcing responsibility. <strong>The</strong> basic<br />

Subscription Price is $100. Order online at https://www.orthoworld.com/order.php or call 440-247-9051.<br />

Copyright 2002-2005 by Knowledge Enterprises, Inc. All rights reserved.<br />

Editor in Chief: Jack Detweiler — jack@orthoworld.com<br />

Assistant Editor: Julie Vetalice — julie@orthoworld.com<br />

Production Coordinator: Julia Ewell — julia@orthoworld.com<br />

BONEZone®<br />

Volume 4 Issue 4<br />

Winter 2005<br />

Contents<br />

FEATURED ZONES<br />

<strong>The</strong> Big Picture<br />

9 • Beyond 2005: Orthopaedic<br />

Companies and their <strong>Supplier</strong>s<br />

March into the Future<br />

John A. Engelhardt<br />

KNOWLEDGE ENTERPRISES, INC.<br />

Product Development<br />

13 • <strong>The</strong> Value of Prototype Iteration<br />

Larry E. James<br />

NEW CONCEPTS PROTOTYPING<br />

17 • Spinal Repair 101<br />

Susan G. Capps, Ph.D.<br />

BENSOL<br />

Logistics<br />

21 • RFID Technology—Uses in<br />

Orthopaedics<br />

Barbara Lyons<br />

PRECIMED, INC.<br />

28 • <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

Technology<br />

85 • Mass Finishing Processes—<br />

Not Just for Marbles Anymore<br />

Kyle Elmblad<br />

HAMMOND ROTO-FINISH<br />

89 • Motor Technology: Varilok Stamping<br />

Process Changes the Rules for Design<br />

of Laminated Stacks<br />

Tom Neuenschwander<br />

LH INDUSTRIES CORP.<br />

91 • Gundrilling: Should We Do<br />

It Ourselves?<br />

Neil Ryall<br />

KAYS ENGINEERING INC.<br />

97 • Plasma Atomization: A Unique<br />

Process for Producing High Purity<br />

Biomedical Powders With<br />

Exceptional Sphericity<br />

Thomas Whitton<br />

AP&C, ADVANCED POWDERS<br />

AND COATINGS<br />

Testing<br />

101 • Comparative Analysis of Bone Cements<br />

and Mixers<br />

Jennifer Robertson, Ph.D.<br />

Grant Hancock<br />

James Rancourt, Ph.D.<br />

POLYMER SOLUTIONS INC.<br />

IN EACH ISSUE<br />

4 • News<br />

5 • Advertiser Index<br />

107 • Calendar<br />

109 • Classifieds<br />

Sales: April Bright — april@orthoworld.com BONEZone • Winter 2005 3


BONE<br />

NEWS<br />

Zone®<br />

4 BONEZone • Winter 2005<br />

COLLABORATIONS<br />

Accellent signed a definitive merger agreement with affiliates of<br />

Kohlberg Kravis Roberts in a transaction valued at ~$1.27 billion,<br />

expected to close by the end of 2005. No changes are currently contemplated<br />

in Accellent’s strategy or operations.<br />

Accellent acquired Machining Technology Group (MTG), which specializes<br />

in rapid prototyping and manufacturing of instruments for<br />

orthopaedic device companies. MTG’s focuses primarily on spine<br />

products, and makes instruments used in knee and hip replacements<br />

and trauma procedures.<br />

Under terms of a new agreement, Leis Partners will serve as the marketing<br />

and sales arm for Advantis Medical, provider of custom delivery<br />

systems for the orthopaedic and medical markets.<br />

Summit Corporate Services renewed an agreement to provide ongoing<br />

services (e.g. patient pre-screening for clinical trials, inventory<br />

management, records maintenance, etc.) for Stryker Spine’s Motion<br />

Prevention unit and the FlexiCore and CerviCore intervertebral disc<br />

replacements.<br />

VIASYS Healthcare acquired Intermed Precision, an ISO 13488<br />

registered developer and supplier of orthopaedic instruments,<br />

implants and micro-machined components used in minimally invasive<br />

surgical devices in Ireland.<br />

CAPABILITIES<br />

Millstone Medical launched the Loaner Expedite Program, a streamlined<br />

system that minimizes the OEM’s inventory, shipping and labor<br />

costs and time to deliver fully-inspected surgical kits to operating<br />

rooms.<br />

Precimed announces Precimed Asia, its new operations in<br />

Guangzhou, China, joining the company’s operations in Switzerland,<br />

the U.S., Japan and the U.K. This new office will provide the additional<br />

help needed to support new and existing sales as well as logistical<br />

follow through on projects for Asian customers.<br />

Precimed closed a CHF 34MM equity transaction (~$27MM USD) to<br />

fund the company’s organic growth and enable strategic acquisitions.<br />

Symmetry Medical opened Symmetry Medical Cheltenham Ltd., a<br />

25,000 square foot facility in the U.K. to provide Total Solutions®,<br />

design services, co-development, prototypes, project management<br />

and Symmetry products in Europe.<br />

Specialty Blades/IncisionTech will invest $6MM to expand its facility<br />

in Stauntion, Virginia. <strong>The</strong> company manufactures precision<br />

cutting and piercing components; its IncisionTech division focuses<br />

solely on OEM medical device applications. <strong>The</strong> project will create 25<br />

new jobs and includes the addition of a 28,000 sq. ft. facility.<br />

VIASYS® Orthopedics/Tecomet opened LaunchQuick, a dedicated<br />

Process Development Center in its Wilmington, Massachusetts<br />

facility. <strong>The</strong> center will produce first articles, small batches for testing<br />

and lab evaluation and pre-series for clinical evaluation. LaunchQuick<br />

is equipped with 4-Axis and 5-Axis Machining Centers, as well as a<br />

9-Axis Integrated Machining Center. In addition, the company has<br />

added a 1,300 ton press to its forging facility.<br />

CERTIFICATIONS<br />

C&W Swiss Inc. has been recommended for ISO 9001:2000 certification,<br />

successfully completing an audit without any non-conformances<br />

or minor non-conformances.<br />

Gauthier Biomedical secured patent number 6,948,605 for an exclusive<br />

ratcheting mechanism used in their extended line of screwdrivers,<br />

designed to limit axial and side-to-side “play” between the<br />

shaft and the handle. <strong>The</strong> design is available in a number of silicone<br />

handle styles and instrument configurations.<br />

Gauthier Biomedical has been recommended for ISO 13485:2003 certification.<br />

Further, for the 2nd consecutive year, the company is<br />

named to the Milwaukee’s Future 50 list of successful and growing<br />

companies. <strong>The</strong> company supplies instruments in the handheld<br />

orthopaedic and spinal instrumentation market.<br />

Holmed Corporation was approved for 13485 certification by TUV. <strong>The</strong><br />

company now has full design capabilities as well as a complete manufacturing<br />

facility dedicated to spine, knees, hip, and shoulder instruments<br />

and implant development.<br />

<strong>The</strong> 1st implantable medical device using Invibio’s PEEK-OPTIMA®<br />

polymer received regulatory clearance in Japan. <strong>The</strong> arthroscopy<br />

device is a tissue repair system used in shoulder procedures. PEEK-<br />

OPTIMA polymer is a thermoplastic designed for medical device<br />

applications requiring blood or tissue contact of more than 30 days.<br />

<strong>The</strong> inherently radiolucent polymer can be modified to offer varying<br />

degrees of radiopacity, and enables clear visualization through imaging<br />

techniques such as x-ray, Computer Tomography and MRI.<br />

RECOGNITIONS<br />

Wayne E. Roberts has joined <strong>The</strong> Electrolizing Corporation of OHIO as<br />

its chief chemist, and Mark Stover has been appointed to serve as<br />

the metal finishing company’s new quality manager. As chief chemist,<br />

Mr. Roberts will lead the company’s ongoing research and development<br />

efforts. Mr. Stover plans to refine the information path from the<br />

customer to the production floor and take a more preventive<br />

approach to solving quality issues. He is currently overseeing the ISO<br />

audit to maintain Electrolizing’s registration to ISO 9001:2000. <strong>The</strong><br />

metal finishing company specializes in advanced coatings for medical<br />

and other high-tech products.<br />

New England Precision Grinding was awarded a Workforce Training<br />

Fund Grant from the state of Massachusetts. <strong>The</strong> company intends to<br />

incorporate lean manufacturing into its production processes.<br />

OMTEC <strong>2006</strong>, the Second Annual Orthopaedic Manufacturing &<br />

Technology Exposition and Conference, will be held June 21-22, <strong>2006</strong><br />

at the Donald E. Stephens Convention Center in Rosemont, Illinois.


OMTEC<br />

<strong>2006</strong><br />

Orthopaedic Manufacturing &<br />

Technology Exposition and<br />

Conference<br />

June 21-22, <strong>2006</strong><br />

Donald E. Stephens<br />

Convention Center<br />

Rosemont, Illinois USA<br />

the international<br />

exposition and conference<br />

to showcase providers<br />

of advanced technologies<br />

for the orthopaedic<br />

manufacturing community.<br />

www.orthosupplier.com<br />

see page 112 for more information<br />

BONEZone®<br />

INDEX OF ADVERTISERS<br />

3-D Machining page 31<br />

Accellent page 35<br />

Acme Manufacting page 29<br />

Beere Medical pages 26-27, 33<br />

Blackstone-NEY Ultrasonics page 19<br />

Boston Centerless page 84<br />

Bradford Tool Group Ltd. pages 6-7<br />

Britton-Gallagher page 95<br />

Cutting Solutions pages 37, 108<br />

Doncasters Medical Technologies page 100<br />

Electrolizing Corp. of OHIO, <strong>The</strong> page 106<br />

Gauthier Biomedical pages 43, 96<br />

Handy & Harman pages 41, 94<br />

Hower Tool page 39<br />

Huron Tool Cutting & Grinding Co. page 45<br />

Jewel Precision page 47<br />

KMedic pages 26-27, 49<br />

Mahar Tool Supply Co. page 55<br />

MAHE page 88<br />

Marox page 53<br />

Marshall Manufacturing page 10<br />

Miltronics & Skye pages 57, 104<br />

Minnesota Rubber & QMR Plastics page 11<br />

M-Pact page 51<br />

Nemcomed page 59<br />

Oberg Industries page 62<br />

OMTEC pages 112-113<br />

Onyx page 61<br />

Pak Manufacturing back cover<br />

Paragon Medical page 15<br />

Pinnacle Technologies pages 24, 63<br />

Precimed front inside cover, 65<br />

Precision Metal Products page 25<br />

Precision Technology, Inc. page 67<br />

Rubber Group, <strong>The</strong>, page 99<br />

Sager Precision Technologies pages 20, 69<br />

Specialized Medical Devices page 71<br />

Stealth Medical Technologies pages 16, 80, 81, 87<br />

Symmetry Medical pages 73, back inside cover<br />

Tecomet pages 12, 75<br />

Teleflex Medical pages 26-27, 79<br />

Tornos Technologies page 8<br />

Unique Instruments pages 77, 105<br />

BONEZone • Winter 2005 5


BRADFORD TOOL<br />

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MANUFACTURERS OF ORTHOPAEDIC SURGICAL CUTTING TOOLS<br />

& PRECISION INSTRUMENTATION<br />

A WIDE RANGE OF PRODUCTS FOR<br />

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• Precision C.N.C. machining<br />

• Laser marking<br />

• Engraving<br />

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• Passivation<br />

• Fast turnaround<br />

• ISO 9001:2000<br />

• Clean room facility<br />

• Packing assembly & test


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ORTHOPAEDIC SURGICAL<br />

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provides you with fast turnarounds for<br />

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of service to the medical industry have<br />

earned us the respect of the orthopaedic<br />

implant manufacturers worldwide. Our<br />

manufacturing offers C.N.C. turning,<br />

C.N.C. grinding, C.N.C. wire eroding,<br />

C.N.C. spark eroding, C.N.C.<br />

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All products can be Electro polished,<br />

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prep drills, calcar trimmer blades, all<br />

types of bone drills, reamers, burrs,<br />

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We have been manufacturing<br />

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ENGINEERING EXCELLENCE TO SATISFY THE DEMANDING NEEDS<br />

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WE ARE SEEKING ADDITIONAL BUSINESS - ALL ENQUIRIES WELCOME<br />

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QUALITY ASSURANCE


Although we won’t have solid numbers until first quarter <strong>2006</strong>,<br />

we estimate that the orthopaedic market grew 15% overall in<br />

2005 to just over $26 billion worldwide. <strong>The</strong> supplier market,<br />

which historically runs at about 7% of that number, grew similarly<br />

according to our preliminary estimates. For many suppliers<br />

it was the best year in the history of their companies. Some of<br />

their customers, however, began to see some slowing in price,<br />

causing them to reassess their directives for the future. Is this a<br />

brief jiggle or the harbinger of a bona fide trend? How will it<br />

affect the supplier/OEM relationship?<br />

Part of the answer lies in the past. We hark back to the early<br />

1990s. Here was the scenario.<br />

Hospitals began to see reconstructive (hip and knee) orthopaedic<br />

procedure profitability fall. <strong>The</strong> cause, they said, was that the<br />

price of orthopaedic implants was rising more rapidly than was<br />

reimbursement, and that the system could not absorb increasingly<br />

sophisticated (and expensive) technology. This was the<br />

dawn of DRG pricing, patient demand matching and hospital<br />

contract pricing. <strong>The</strong> net results were:<br />

• Hospitals were able to negotiate lower pricing<br />

• Manufacturers experienced lower margins and a shift to less<br />

expensive technologies (mix shift)<br />

<strong>The</strong> manufacturers in turn scrambled to “partner” with their<br />

suppliers, which to some suppliers simply meant “getting partnered”<br />

for better pricing.<br />

What followed was one of the most exciting (and anxietyproducing)<br />

eras in industry history.<br />

In order to increase breadth of line and total profits, the<br />

orthopaedic industry began a rapid consolidation. Orthopaedic<br />

manufacturers went on a buying and merging spree, and soon<br />

after, so did their suppliers. Exhibit 1 illustrates this activity<br />

through the key time in question alongside growth of the bellwether<br />

hip and knee markets.<br />

John A. Engelhardt<br />

Chief Executive Officer<br />

Knowledge Enterprises, Inc.<br />

THE BIG PICTURE<br />

Beyond 2005: Orthopaedic Companies<br />

and their <strong>Supplier</strong>s March into the Future<br />

EXHIBIT 1<br />

INDUSTRY CONSOLIDATION 1993 TO 2003 AND<br />

GLOBAL RECON GROWTH<br />

During this time Stryker Howmedica was formed, as was DePuy<br />

AcroMed (a Johnson & Johnson company), Medtronic Sofamor<br />

Danek and many other key players of today. This occurred in<br />

direct response to market growth dynamics. (For a complete list<br />

of orthopaedic merger & acquisition activity, please visit<br />

www.orthoworld.com/members/pdf/publications/acquisitions.pdf.)<br />

By 1996, growth had begun increasing again from 3% to more<br />

than 20% by 2004! Why the history lesson, you ask? Because we<br />

are once again in a similar cycle.<br />

Predicting the Future from the Past<br />

<strong>The</strong> dynamics of the early 1990s are emerging in a nearly<br />

identical fashion today.<br />

A slowdown in reconstructive pricing and mix shift began this<br />

year. All major recon players have been impacted, and their stock<br />

prices have reflected this. Pricing is hitting the wall in the spine<br />

and biologics markets also—a direct result of the same drivers.<br />

continued on page 10<br />

BONEZone • Winter 2005 9


THE BIG PICTURE<br />

Beyond 2005, continued from page 9<br />

Savvy suppliers have seen this coming and have begun the<br />

process of building for the future, many through consolidation<br />

and financing of growth. Exhibit 2 summarizes recent examples<br />

of this activity.<br />

EXHIBIT 2<br />

KEY 2005 SUPPLIER ACTIVITY<br />

Company Transaction<br />

Paragon Equity Investment<br />

Unique Merger<br />

Precimed Equity Investment<br />

Seabrook Equity Investment<br />

Campbell Engineering Sale<br />

Accellent Equity Investment<br />

A primary motivation for all of this is the expansion of the<br />

breadth of services that the supplier can offer to its customers, in<br />

hopes of providing more value to the customer and spreading the<br />

risk for the supplier.<br />

Is the Sky Falling?<br />

Absolutely not. <strong>The</strong> demand for orthopaedic devices will continue<br />

to soar, based on a perfect storm of global demographics. Age,<br />

activity, obesity; every seven seconds, someone turns 50! <strong>The</strong> current<br />

cycle is one of slowing growth, not a shrinking market. Once<br />

healthcare reimbursements adjust to the economics that technology<br />

demands, and once hospitals, industry and the rest of the<br />

supply chain evolve to accommodate those demands, growth will<br />

increase with a vengeance. <strong>The</strong> last cycle took several years. This<br />

one is already showing signs of being far shorter.<br />

In the meantime, expect more consolidation of both companies<br />

and suppliers, and at the same time new ones of both.<br />

<strong>The</strong> Company/<strong>Supplier</strong> Relationship<br />

As we manage our way through this cycle, life changes only<br />

slightly, but the unprepared on both sides will suffer.<br />

<strong>The</strong> orthopaedic companies will increasingly need suppliers who<br />

are cheaper AND better AND faster. Any supplier who plans on<br />

ignoring the ands in the last sentence will get whupped during<br />

the adjustment of the next few years.<br />

<strong>The</strong> relationship between supplier and company will become<br />

more intimate in order to gain efficiencies. Real time inventory<br />

tracking against blanket purchase orders will allow suppliers to<br />

build when they have capacity and keep the OEM off of<br />

backorder.<br />

Nearly all orthopaedic companies predict more being brought in,<br />

and at the same time more being outsourced. <strong>Supplier</strong>s are increasingly<br />

developing programs to actively help their customers<br />

insource the operations that make the most sense from a resource<br />

10 BONEZone • Winter 2005<br />

efficiency and profitability standpoint, and outsource those that<br />

don’t and never will. A true partnership is emerging.<br />

Real innovation will be rewarded as never before, from more efficient<br />

manufacturing methods to instruments of higher cosmetic<br />

quality and functionality. Streamlining inventory management<br />

will be key. (<strong>Supplier</strong>s can stop groaning about their customer’s<br />

lack of production planning, and accept this as characteristic of<br />

the business we are in. Short runs in a hurry will always be the<br />

norm. Find a better way to deal with it.)<br />

For those on both sides of the supplier/company equation, this is<br />

a great time to be alive in orthopaedics. <strong>The</strong> old “we/they” paradigm<br />

will give way to solving each other’s problems. Sourcing decisions<br />

based on price only will be more dangerous in the years<br />

ahead. On time, every time will be the new mantra. A more<br />

intense level of cooperation will make it a reality.<br />

John Engelhardt is Chief Executive Officer of Knowledge Enterprises,<br />

Inc. as well as Editor in Chief of U.S. Orthopaedic Product News.<br />

He holds 19 patents for orthopaedic technologies and has published<br />

numerous articles in the academic and popular press on orthopaedic<br />

technologies and trends. He can be reached at 440-247-9051 or<br />

john@orthoworld.com.<br />

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Introduction<br />

How well and how quickly a product design is developed largely<br />

determines the product’s longevity and, ultimately, its gross revenues<br />

and profitability. In the design cycle, the importance of<br />

prototyping during the machining of orthopaedic implants and<br />

surgical instruments cannot be overestimated. In the first phase<br />

of development, prototypes are machined from materials that are<br />

easy and less expensive to work with and, later in the development<br />

process, from materials in which the end product will be<br />

produced.<br />

Iterative Prototyping<br />

<strong>The</strong> key to a strong and mature design is to maximize the number<br />

of iterations of the design and to thoroughly test them. All<br />

the up-front thinking in the world can often overlook a minor or<br />

even major flaw that a prototype will expose. Every successive<br />

prototype and lab experiment adds insight leading to a more<br />

mature design. While computer modeling is a valuable tool for<br />

design, it cannot supplant the benefits gained from prototypes<br />

and associated lab experimentation.<br />

As an example, a start-up company developing a spinal implant<br />

machined the first prototype in brass from the design solid<br />

model. <strong>The</strong> prototype was one step beyond a Rapid Prototype<br />

and was a useful visualization tool. <strong>The</strong> next three to five prototype<br />

iterations were also non-functional, but were machined in<br />

303 S.S. and used in plastic skeletal mock-ups.<br />

As the design progressed to the point where initial lab studies<br />

were needed, the prototypes were machined in both 303 S.S. (for<br />

ease of machining) and 17-4PH S.S. (for use in gauging stresses).<br />

This phase consisted of eight to ten iterations.<br />

As the engineers came to understand the issues in play and the<br />

design was close to fully-functional, the prototype iterations were<br />

produced in the anticipated production materials of titanium and<br />

cobalt-chrome. Over ten iterations were made, and these prototypes<br />

represented the final stage of the process before the design<br />

was frozen and the product taken to trials.<br />

Larry E. James<br />

President<br />

New Concepts Prototyping and Production<br />

PRODUCT DEVELOPMENT<br />

<strong>The</strong> Value of Prototype Iteration<br />

As the design developed to a point of functionality that was near<br />

expectation, the company launched a schedule of weekly cadaver<br />

labs in which the latest iterations were tested. A team of engineers<br />

and physicians evaluated components and techniques and,<br />

in one or two days after each lab, would have new designs for<br />

further prototyping. A small number of new prototypes were<br />

built every week for the next week’s lab, giving this team fullyfunctioning<br />

labs every week with the ability to adjust and<br />

improve their designs.<br />

Knowledge gleaned from the successive lab experiences accelerated<br />

the development process exponentially, leading to more functional<br />

designs and refined techniques. <strong>The</strong> speed with which the<br />

design iterations were produced enabled the company to enter<br />

human trials much sooner than anticipated. Although the intense<br />

schedule required major commitments from both company and<br />

supplier, the dividends were large in terms of enabling the introduction<br />

of a superior product and the achievement of maximum<br />

profitability.<br />

Basic Reverse Chart<br />

In the 1980s, Harvard Business Review published a tool used in<br />

the prototyping example given above and known as the Reverse<br />

Chart. This tool helped decision-makers assess the value of expediting<br />

a product’s time-to-market and evaluate specific design feature-sets<br />

in light of overall company impact. For a product<br />

development team, the chart can help visualize the financial<br />

impact of their decisions.<br />

As seen in Figure 1 on the following page, the Reverse Chart is<br />

simply a 2-axis graph that plots anticipated Cumulative<br />

Development Expenses and anticipated Cumulative Gross<br />

Income. <strong>The</strong> horizontal axis represents time and the vertical axis<br />

represents dollars in logarithmic scale.<br />

In a typical project, R&D expenses start out slowly and accelerate<br />

until product introduction, at which time they flatten slowly.<br />

Eventually, the product is mature and no further development<br />

costs are incurred. <strong>The</strong> income curve initializes at some point<br />

after the project begins and (hopefully) climbs steeply throughout<br />

continued on page 14<br />

BONEZone • Winter 2005 13


PRODUCT DEVELOPMENT<br />

Prototype Iteration, continued from page 13<br />

the product’s life until full maturity, when the curve slowly flattens.<br />

<strong>The</strong> product development team’s focus is to maximize profitability<br />

of the product, represented in the Reverse Chart as the<br />

Cumulative Gross Income less the Cumulative Development<br />

Expense. In this example, the product was introduced in approximately<br />

three years at an expense of almost $6MM. <strong>The</strong><br />

Cumulative Gross Income was $220MM in a ten-year period.<br />

Accelerated Reverse Chart<br />

<strong>The</strong> chart in Figure 2 illustrates accelerated development. <strong>The</strong><br />

product was introduced in approximately two years at an expense<br />

of almost $12.5MM. <strong>The</strong> reward: cumulative sales of $410MM<br />

in the same ten-year period.<br />

<strong>The</strong> elegance of a Reverse Chart lies in its simplicity and in its<br />

direct impact on decision-making. A key to using the chart is to<br />

keep it simple. <strong>The</strong> power of this tool is in playing “what-if” scenarios<br />

and in adjusting the chart accordingly. After some study, it<br />

will be understood that a decrease in development time—even<br />

with an associated increase in cost—can have a measurable positive<br />

effect on revenues and profitability.<br />

Summary<br />

Questions to ask: “How much more development money<br />

can/should we spend to produce a superior product?” and,<br />

14 BONEZone • Winter 2005<br />

Figure 1<br />

Figure 2<br />

“What will be the impact on revenues?” A particular feature may<br />

not have the payback originally thought, in which case the<br />

feature might be eliminated from further consideration.<br />

A large number of quickly-executed prototypes is one of the key<br />

ways to accelerate the development time and give a very positive<br />

impact to the overall gross revenue. A Reverse Chart helps visualize<br />

this dynamic and can be a valuable tool in quantifying the<br />

impact of design decisions on company profits.<br />

In either case, the Reverse Chart is a helpful tool in making the<br />

best possible decision that speeds up time-to-market, quickens<br />

momentum, maximizes market share and extends a product’s life<br />

cycle.<br />

New Concepts Prototyping and Production provides high-end contract<br />

machining services and is focused on multi-axis machining of<br />

complex surfaces and implant geometries for the orthopaedic market.<br />

Larry James is President of New Concepts. He can be reached at<br />

larry@ncproto.com.<br />

New Concepts Prototyping and Production<br />

1311 North 35th Street<br />

Seattle, WA 98103 USA<br />

206-633-3111 (phone)<br />

203-633-3114 (fax)<br />

BZ 6/7/05 2:06 AM Page FC1<br />

Interested in contributing an<br />

article for publication in<br />

BONEZone ®?<br />

BONE Zone®<br />

Strategic Sourcing for the Orthopaedic Industry<br />

A Knowledge Enterprises, Inc. Publication<br />

www.orthosupplier.com<br />

Volume 4 Issue 2<br />

Summer 2005<br />

In this Issue:<br />

Forging<br />

A Knowledge Enterprises, Inc. Publication<br />

www.orthosupplier.com<br />

FallBZ. 9/13/05 11:36 PM Page 1<br />

BONE Zone®<br />

Straateegiicc Souurrciinngg foor thhe Orrtthooppaaeediicc Inndussttry<br />

In this Issue:<br />

MACHINING<br />

Editorial content and topics of<br />

interest are always welcomed.<br />

email: bonezone@orthoworld.com<br />

Volume 4 Issue 3<br />

Fall 2005


Susan G. Capps, Ph.D.<br />

President<br />

BENSOL<br />

Approximately 80% of Americans have at least one episode of<br />

significant lower back pain in their lives. Health care costs associated<br />

with back pain are estimated to exceed $60 billion; the indirect<br />

economic losses due to lost wages and decreased productivity<br />

are staggering. <strong>The</strong> sheer number of spinal procedures performed<br />

annually is increasing due to better diagnostics, increased patient<br />

awareness, an aging population and technological advances.<br />

Back pain has many causes. Degenerative disc disease is common;<br />

as we age, our intervertebral discs tend to lose water and gain collagen.<br />

<strong>The</strong>ir ability to function properly degenerates. Other common<br />

causes of back pain include spinal stenosis and osteoporotic<br />

fractures. Spine surgeries are intended to relieve pain, prevent<br />

neurological damage and restore function through spinal stabilization.<br />

As our understanding of spinal mechanics has advanced,<br />

a new goal has emerged: to minimize unintended changes to<br />

spine biomechanics and thereby reduce future degeneration at<br />

adjacent spinal levels.<br />

Remembering that purpose, shape and materials influence design,<br />

three methods of spinal repair will be discussed:<br />

1. Rigid Stabilization<br />

2. Semi-Rigid Stabilization<br />

3. Disc Arthroplasty<br />

Rigid Stabilization<br />

Fusion occurs when new bone grows between two vertebrae, creating<br />

a solid “bridge” (the intervertebral disc is removed to allow<br />

new bone growth). Rigid stabilization has a long history of clinical<br />

success; its intended function is to prevent excessive motion<br />

from inhibiting bone formation. Spinal cages and/or rigid spinal<br />

fixation are employed to provide stabilization.<br />

Spinal cages are inserted between vertebrae, into the intervertebral<br />

space. Ridges, teeth and/or screw threads grip the vertebrae,<br />

effecting immediate mechanical stabilization. <strong>The</strong>ir hollow shape<br />

is often filled with either autogenous bone graft or an osteobiologic<br />

substance to encourage bone growth, creating eventual rigid<br />

biologic stabilization. Holes placed along the shapes allow bone<br />

cells access to the core. Some spinal cages are shaped like hollowed-out<br />

screw bodies with holes along the cylinder; these<br />

shapes are often made of metal alloys and are placed bilaterally.<br />

Spinal Repair 101<br />

Some spinal cages are<br />

irregularly shaped<br />

boxes with ridges or<br />

teeth; these are often<br />

made of polymeric<br />

materials. In general,<br />

there is no difference<br />

in the ability of these<br />

PRODUCT DEVELOPMENT<br />

Exhibit 1: Examples of Spinal Cages<br />

• Bagby and Kuslich (BAK) Cage<br />

• Ray Threaded Fusion Cage<br />

• Lumbar I/F Cage<br />

• InterFix Threaded Fusion Device<br />

designs to stabilize the spine in flexion, axial rotation and lateral<br />

bending. i Some examples of spinal cages are given in Exhibit 1.<br />

Rigid spinal fixation systems comprise constructs of rods, plates,<br />

hooks and/or screws. <strong>The</strong>se systems may be used in conjunction<br />

with spinal cages to enhance fusion rates. Usually, the system of<br />

stabilizers (rods, plates) and connectors (hooks, screws) is made<br />

from metal alloys.<br />

Rigid stabilization is believed to cause accelerated degeneration of<br />

adjacent discs due to increased stresses caused by abrupt stiffness<br />

and motion changes. Further, in an osteoporotic spine, the<br />

changes in stress distribution may contribute heavily to adjacent<br />

level compressive fractures of the vertebrae. Concerns about the<br />

loss of movement (flexion, rotation and bending) are issues for<br />

some patients. Exhibit 2 illustrates possible advantages and pitfalls<br />

of rigid stabilization.<br />

Exhibit 2:<br />

Rigid Stabilization – Potential Advantages and Disadvantages<br />

Advantage Disadvantage<br />

History of clinical success Adjacent disc degeneration<br />

Aids in spinal fusion Adjacent vertebrae fracture<br />

Loss of movement<br />

Semi-rigid Stabilization<br />

Semi-rigid or dynamic stabilization systems are intended to stabilize<br />

spine segments and preserve anatomy and natural spine<br />

continued on page 18<br />

BONEZone • Winter 2005 17


PRODUCT DEVELOPMENT<br />

Spinal Repair 101, continued from page 17<br />

Exhibit 3:<br />

Examples of<br />

Semi-rigid Systems<br />

• ArcTec<br />

• Dynesys<br />

• Isolock<br />

18 BONEZone • Winter 2005<br />

motion, not encourage<br />

fusion. Some examples of<br />

semi-rigid devices are indicated<br />

in Exhibit 3.<br />

By decreasing rod stiffness<br />

and increasing axial motion,<br />

there is a more gradual stiffness<br />

and motion transition. ii<br />

This causes lower maximum stresses in adjacent discs. More<br />

importantly, the area of disc tissue exposed to high amplitude<br />

stress is reduced by almost half. iii <strong>The</strong> materials used in semi-rigid<br />

stabilization systems are not necessarily different from those<br />

found in rigid systems, but geometry will change to create less<br />

stiff components. For example, metal rods and plates will be<br />

more slender or thinner and therefore, more flexible. Some systems<br />

make use of different materials such as surgical<br />

polyurethane tubing and polyethylene cord (Dynesys).<br />

Spine segments are stabilized by components that offer enough<br />

support and rigidity to prevent excessive motion and further<br />

damage to the intervertebral discs and other spinal soft tissues.<br />

Spinal anatomy is preserved, since semi-rigid systems do not<br />

require removal of the intervertebral disc or vertebral alteration.<br />

Since fusion is not the goal of semi-rigid fixation, natural spinal<br />

motion is encouraged. Exhibit 4 presents possible advantages and<br />

pitfalls of semi-rigid stabilization.<br />

Exhibit 4:<br />

Semi-rigid Stabilization –<br />

Potential Advantages and Disadvantages<br />

Advantage Disadvantage<br />

“Kinder” to surrounding tissues Lack of clinical history<br />

Don’t create large stress-risers Some materials are “new”<br />

Movement is preserved to spinal application<br />

Total Disc Replacement/Arthroplasty<br />

<strong>The</strong>re are two different concepts in total disc replacement/arthroplasty:<br />

replace the intervertebral disc, and replace the intervertebral<br />

articulation.<br />

In either concept, design constraints are the same: high fatigue<br />

strength, minimal wear debris and, if possible, “friendly” imaging<br />

properties. Some of these devices are undergoing clinical testing<br />

and still others are available for implantation in the U.S. An artificial<br />

disc may undergo over 106 million loading cycles, and so<br />

must have high fatigue strength. It must reproduce physiologic<br />

stiffness in all planes of motion and it must accurately transmit<br />

physiologic stress.<br />

Intervertebral Disc Replacements<br />

Prosthetic intervertebral discs are designed with focus on the<br />

following behaviors: hydraulic, elastic and mechanical. Hydrogel<br />

prostheses, PDNs, are used to replace the central region of the<br />

intervertebral disc by addressing the hydraulic properties. <strong>The</strong>se<br />

prostheses contain dehydrated hydrogel contained in a woven<br />

polyethylene jacket; after insertion, the hydrogel absorbs fluid<br />

and expands. <strong>The</strong> bilateral placement of two implants in the disc<br />

space provides the lift needed to restore and maintain disc space<br />

height. Another intervertebral disc prosthesis uses elastic properties<br />

as its design focus. This second generation elastic disc prosthesis<br />

has a silicone<br />

elastomer core<br />

bonded to two titanium<br />

endplates.<br />

Some examples of<br />

total disc replacements<br />

are indicated<br />

in Exhibit 5.<br />

Exhibit 5:<br />

Examples of Total<br />

Disc Replacements<br />

• Prosthetic Disc Nucleus (PDN)<br />

• Acroflex Disc<br />

Articulating Discs<br />

Most articulating disc prostheses are composed of two articulating<br />

metal endplates and a polymer or metal ball spacer. For these<br />

prostheses, the endplates are affixed to the vertebral bodies and<br />

the spacers articulate between them. Exhibit 6 lists examples of<br />

articulating devices.<br />

Exhibit 6:<br />

Examples of Total Disc Arthroplasty (Articulating Discs)<br />

Lumbar Prostheses Cervical Prostheses<br />

• Charité • Prestige<br />

• Maverick • Bristol<br />

• ProDisc • ProDisc-C<br />

• FlexiCore • FlexiCore<br />

Exhibit 7 lists possible advantages and pitfalls of total disc<br />

replacement/arthroplasty.<br />

Exhibit 7:<br />

Total Disc Replacement/Arthroplasty –<br />

Potential Advantages and Disadvantages<br />

Advantage Disadvantage<br />

Removes/replaces Possibility of<br />

degenerate tissue wear debris issues<br />

Maintains articulation History of clinical use<br />

not fully established<br />

Promising early results


Summary<br />

For all of these spinal repair constructs, the concerns are the<br />

same as for any other orthopaedic implant: osteolysis, allergic<br />

reactions and infections. In general, the corrosion products from<br />

devices like plates, screws and rods are not clinically significant. iv<br />

Some spinal cages are made of nitinol, a nickel-titanium alloy.<br />

When nitinol particles were implanted directly into the spinal<br />

canal, the response was noted as being very similar to titanium<br />

alloy particles; both are highly biocompatible. iv Macroscopic and<br />

histologic analysis of spinal cord, dura mater and soft tissues after<br />

exposure to particles from other spinal components made of titanium<br />

alloy, cobalt chrome alloy, polyethylenes and polyurethanes<br />

showed no significant adverse reactions. Wear debris and corrosion<br />

products from stainless steel, cobalt chrome alloy, titanium<br />

alloy and polyethylene used in articulating discs are topics for<br />

future clinical studies, but at present there are no significant<br />

detrimental effects.<br />

i Oxland TR, Hoffer Z, Nydegger T, Rathonyi GC, Nolte LP: A comparative biomechanical<br />

investigation of anterior lumbar interbody cages: Central and bilateral approaches. J Bone<br />

Joint Surg 83A(3): 383-393, 2000.<br />

ii Hao H, Saigal S, Castellvi AE, Clabeaux DH, Pienkowski D: Finite element analysis of<br />

dynamic instrumentation demonstrates stress reduction in adjacent level discs. 51st<br />

Annual Meeting of the Orthopaedic Research Society, Poster No: 1313.<br />

iii Traynelis V and Haid Jr RW: Spinal Disc Replacement: <strong>The</strong> development of artificial<br />

discs. www.spineuniverse.com/displayarticle.php/article1245.html<br />

iv Rapp S: Orthopedics Today, January 2004.<br />

www.slackinc.com/bone/ortoday/200401/metal.asp<br />

Susan Capps, Ph.D. provides research, analysis and communication<br />

services to the orthopaedic device industry and to orthopaedic surgeons.<br />

She has written white papers for various orthopaedic companies<br />

on a broad range of topics from orthobiologics, FDA regulations,<br />

surgical instruments/trays to total joint arthroplasty issues. Past projects<br />

have also included meta-analyses of total hip replacements, statistical<br />

analyses of clinical outcomes, detailed case studies and literature<br />

summaries for FDA submissions.<br />

Susan G. Capps, Ph.D.<br />

BENSOL<br />

P.O. Box 861<br />

Warsaw, IN 46581 USA<br />

574-834-4139 phone & fax<br />

biomechs@sgcappsphd.com<br />

PRODUCT DEVELOPMENT<br />

BONEZone • Winter 2005 19


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Precision machining<br />

Electropolishing<br />

Titanium anodizing<br />

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Clean room packaging<br />

<strong>Supplier</strong>-managed<br />

inventory<br />

ISO 9001:2000<br />

13485:2003 Certified<br />

FDA Registered<br />

Single source manufacturing,<br />

from head to toe.<br />

www.sagerprecision.com<br />

123 Moore Road, Weymouth, MA 02189 • Telephone (781) 335-5300<br />

A Division of Autocam Corporation


Imagine yourself as a patient facing surgery. You may be wondering,<br />

“When were those instruments last sterilized? How many<br />

times have they been used? Did the surgical assistant account for<br />

all of the instruments used during my surgery?”<br />

Imagine yourself as the surgeon, thinking, “When was this torque<br />

limiter last calibrated? Is this reamer still sharp enough? Is there a<br />

surgical technique I can review for this instrument?”<br />

Answering these questions is made easier with the use of radio<br />

frequency identification (RFID), now available to the<br />

orthopaedic industry worldwide.<br />

Barbara Lyons<br />

Director of Global Marketing<br />

Precimed<br />

<strong>The</strong> technology, heretofore illusive for a hostile metal environment,<br />

has been refined so that metal orthopaedic instruments can<br />

house an RFID tag that provides dynamic information about the<br />

instrument throughout its life cycle and history. MBBS, a Swissbased<br />

company, is a group of engineering specialists in the field<br />

of micro-technology and micro-electronics who provide a complete<br />

range of RFID solutions for the medical industry. <strong>The</strong>ir<br />

unique and patented technology allows one to retrieve and record<br />

data directly from and to the instrument using through-metal<br />

RFID solutions—useful for traceability, product identification<br />

and testing validation, to name only a few applications.<br />

LOGISTICS<br />

RFID TECHNOLOGY —<br />

Uses in Orthopaedics<br />

Uses in Traceability<br />

A study done in the U.K. investigated key critical areas for tracking<br />

instrumentation through the hospital, and ultimately to the<br />

use of instruments on individual patients. <strong>The</strong> results of this<br />

study were recently published in <strong>The</strong> Clinical Services Journal,<br />

September 2005 issue. As Figure 1 illustrates, the life cycle of<br />

orthopaedic instruments has several stages, from the time it leaves<br />

the manufacturer to the time it arrives at the operating room.<br />

Critical data is needed at every step along the way.<br />

TRANSPORT<br />

USE<br />

ACQUISITION<br />

1. Purchase<br />

2. Loan<br />

STORAGE<br />

CLEANING<br />

At all stages<br />

Location<br />

Facilities<br />

Equipment<br />

Management<br />

Policies/Procedures<br />

TRANSPORT<br />

DISINFECTION<br />

STERILIZATION<br />

INSPECTION<br />

PACKAGING<br />

Figure 1 – <strong>The</strong> life cycle of instruments.<br />

DISPOSAL<br />

1. Scrap<br />

2. Return to lender<br />

One major area in which RFID traceability can be beneficial is<br />

patient identification. Amid recent concerns with Variant<br />

Creutzfeldt-Jakob disease (“mad cow”), instrument use traceability<br />

has become a heightened issue. Since the Variant Creutzfeldt-<br />

Jakob disease bacterium is not destroyed by common sterilization<br />

practices, it causes grave concern for hospitals and surgeons when<br />

it is discovered post-operatively that a patient was infected with<br />

the virus. Typical protocol has been to recall any patient who had<br />

surgery after that infected individual and who might have been<br />

exposed to the virus due to similar instrument usage. In this<br />

instance, RFID allows for the tracking of an instrument to<br />

continued on page 22<br />

BONEZone • Winter 2005 21


LOGISTICS<br />

RFID Technology, continued from page 21<br />

individual patients and surgical case numbers. Thus, instead of<br />

recalling 500 patients to the hospital for testing, it is necessary to<br />

only inform the two or three who were exposed to the same<br />

instruments. How does this work? Each instrument within a sterilization<br />

tray or kit is equipped with an RFID chip, mounted on<br />

the instrument or embedded during manufacture and fully<br />

encapsulated in metal so that it can withstand stringent sterilization<br />

and autoclaving. This chip records data at each step the<br />

instrument takes from the manufacturer all the way through to<br />

the operating room and back again. (See Figure 2.)<br />

Figure 2 – Tracing the steps that the instrument takes.<br />

This is just one example of why a hospital would want to use the<br />

RFID technology. <strong>The</strong> benefits—for hospital and patient—are<br />

obvious.<br />

<strong>The</strong> OEM benefits, as well. Asset tracking and inventory management<br />

are significant logistic challenges for many manufacturers.<br />

Instrument kits are often sent to hospitals as part of a loaner<br />

system. Volumes of paper often accompany those instruments in<br />

order to track their usage and validate that they are suitable for<br />

use. RFID chips embedded directly in the instruments virtually<br />

eliminate the need for extensive paperwork. Data can be stored,<br />

recalled and written directly on the instrument itself. <strong>The</strong> name<br />

22 BONEZone • Winter 2005<br />

of the hospital, the date it was sent, and what the kit contained<br />

can be identified within seconds using a chip reader that projects<br />

the data onto a computer screen. That computer screen can be a<br />

CPU or a handheld PDA, offering considerable convenience<br />

when picking up a kit from one hospital to transport it to the<br />

next. When the kits are returned from the hospital, a bill of<br />

materials, read directly from the tray, can quickly determine if all<br />

of the instruments sent to the hospital were returned. <strong>The</strong> savings<br />

in lost instruments alone can be dramatic. Even if the hospital<br />

does not want to participate in the program, OEMs can still benefit<br />

from the RFID technology by keeping track of instruments<br />

through their own database.<br />

What if you don’t have a loaner system? Can RFID still be a benefit?<br />

In essence, with an RFID tag as part of the instrument, the<br />

instrument keeps a detailed record of its own history. Traceability<br />

data from raw material to patient can be stored directly on the<br />

instrument, allowing it to carry and maintain its own record<br />

throughout its life cycle. As revealed in Figure 3, an acetabular<br />

reamer can tell you:<br />

Raw material manufacturer<br />

Date of manufacture<br />

Part number<br />

Order number<br />

Shipping and receiving dates<br />

Name of hospital<br />

Number of times used<br />

Each surgical case number<br />

Sterilization record<br />

When to replace<br />

Etc.<br />

RFID Chip<br />

Figure 3 – <strong>The</strong> “talking” reamer<br />

Two concurrent studies on inventory management control are<br />

being conducted in France and Switzerland at the time of this<br />

writing. Early results from both reveal a 50% improvement in<br />

through-put and productivity, just by storing all identification<br />

information directly on the instrument (Source: MBBS SA), in<br />

effect making RFID built-in, intelligent design.<br />

Uses in Product Identification<br />

With the rise in minimally invasive surgical techniques and the<br />

use of computers in surgery, the need for the ease of product<br />

identification becomes more critical. In computer aided surgery,<br />

key elements of the process require manual input of data to generate<br />

the proper surgical protocol. RFID eliminates the need for<br />

the manual input, thus reducing the risk of error.<br />

For instance, an RFID reader embedded in an acetabular reamer<br />

driver reads the tag embedded in an acetabular reamer and


identifies its size and tolerance values, transfers that data to the<br />

computer, calculates those values in conjunction with the reamer<br />

driver’s tolerances and plots the course for the surgeon to follow,<br />

all without manual data input in the operating room.<br />

A power tool equipped with a reader can identify an instrument<br />

by its tag. This is vital information when considering the RPM<br />

variations for similar-but-different instruments. Product recognition<br />

makes the difference between the proper and improper use<br />

of items. RFID can add significantly to the reassurance level that<br />

a drill or a tap attached to a power source is being used at the<br />

proper speed and rotation for the instrument. No one needs to<br />

be reminded of the complications associated with a broken drill<br />

bit or tap during a plating procedure.<br />

Even something as simple as identifying the contents of a tray<br />

can add benefit. Imagine five sterilized and wrapped trays sitting<br />

within the sterile field, all filled with different sets of instruments.<br />

Within the course of the surgery the surgeon needs just one<br />

instrument - located in one of those trays. A quick scan of an<br />

RFID tag (such as the MediTAG in Figure 4) on each tray can<br />

identify a bill of materials, telling the surgical assistant what’s<br />

inside. So, instead of opening<br />

each tray and searching<br />

for the instrument needed,<br />

one tray is identified.<br />

Further, the layout of each<br />

instrument within the tray<br />

can be displayed on the<br />

computer screen and the<br />

Figure 4 – MediTAG desired instrument quickly<br />

retrieved.<br />

Testing and Usage<br />

Torque limiters are valuable instruments in orthopaedics.<br />

Applying the right amount of torque to a driver so that a screw is<br />

not over- or under-rotated or stripped is critical in many applications.<br />

However, how many times has that torque limiter been<br />

used? When was the last time it was recalibrated? How can you<br />

be sure that an instrument is set to the proper torque limit at any<br />

given moment? RFID can eliminate the guesswork. (See Figure<br />

5.) An RFID tag mounted directly on a torque limiter can keep<br />

up-to-date records of the calibrated torque value, and tell you<br />

when it’s time to send it back to the manufacturer for recalibration.<br />

Torque limiters are just one example of how this technology can<br />

keep track of an instrument’s history and life cycle. Knowing<br />

when to replace an instrument is valuable. Automatic counters<br />

can be built into the tag/reader technology so that each usage is<br />

recorded, without human intervention.<br />

Validation<br />

As part of the U.K. study mentioned earlier, a sterilization validation<br />

test was conducted. “During the three-month project period<br />

the tags were subjected to more than 500 cycles at 134°C to<br />

Update Data...<br />

Tag #<br />

Lot #<br />

Manufacturing Date<br />

Date Received<br />

Return Date<br />

Manufacturing Date<br />

Recalibration Date<br />

Recalibration Date<br />

Recalibration Date<br />

Recalibration Date<br />

Part #<br />

Order #<br />

Torque Value<br />

Torque Value<br />

Torque Value<br />

Torque Value<br />

Torque Value<br />

LOGISTICS<br />

# Of Uses<br />

Sterilization Date Sterilization Certificate #<br />

Last Surgery Date<br />

Calibration Record<br />

(For Validation of Torque Value)<br />

Torque Value<br />

READ WRITE SAVE DELETE<br />

Figure 5 – <strong>The</strong> calibration screen eliminates guesswork.<br />

137°C, with no noticeable degradation in their reading/writing<br />

ability nor in their fixation to the metal plate.” (Source: “Chips<br />

are good for you,” <strong>The</strong> Clinical Services Journal, September 2005,<br />

page 28.) Since the tags are passive (meaning they have no battery<br />

or power source on their own), they will last for the life of<br />

the instrument. All the energy comes from the reader/writer,<br />

which then transmits the information from the tag to the database.<br />

<strong>The</strong> study also reported that “there were no reported ongoing<br />

problems with the software application, which resulted in a<br />

high level of user acceptance of the system.”<br />

It Doesn’t Work if You Don’t Use It<br />

RFID technology is a powerful tool that can add value to the<br />

bottom line for manufacturers, OEMs, distributors, hospitals and<br />

surgeons. Only a few uses are mentioned here. Asset and inventory<br />

control managers have heralded the value of this technology in<br />

many industries. However, you need to use it for it to be effective.<br />

This begs the question, “What does it take to implement?”<br />

<strong>The</strong> technology consists of three main components: the tag<br />

(embedded chip), the reader/writer and the integration software<br />

to make it work with your existing database system. (See Figure 6<br />

on the following page.) Once you determine what data you want<br />

to track, the tag is programmed to record and retrieve that data.<br />

<strong>The</strong> reader/writer transmits that data from the tag to the database.<br />

<strong>The</strong> beauty of this system is that it can integrate directly<br />

into your existing database.<br />

<strong>The</strong>re is no costly Enterprise Resource Planning process to go<br />

through, no need to change the system you’re currently using.<br />

continued on page 24<br />

BONEZone • Winter 2005 23


LOGISTICS<br />

RFID Technology, continued from page 23<br />

Read/Write<br />

Read/Write<br />

module<br />

Electronic Electronic<br />

Electronic<br />

circuit circuit circuit<br />

Energy<br />

Data<br />

TAG TAG<br />

<strong>The</strong> data on the tag appears on your computer screen in much<br />

the same way as you are entering the data manually now. <strong>The</strong><br />

software component is the platform used to make the integration<br />

happen. <strong>The</strong> manufacturer can have one database system, the<br />

OEM another and the hospital yet another—the same tag and<br />

reader will work with all three.<br />

Visit...<br />

IC<br />

Data can be exchanged between<br />

TAG and Read/write Module<br />

Figure 6 – Components of RFID technology.<br />

www.PinnacleTechnologies.com<br />

www.PinnacleTechnologies.com<br />

<strong>The</strong> final component is the user. If you don’t read the tag, the<br />

database will not retrieve the information. If you do not write the<br />

new information back to the tag, it will not record the data. It is<br />

not 100% foolproof. But, it’s better than any paper tracking system<br />

in use today, and apparently major retailer Wal-Mart and the<br />

U.S. Department of Defense agree.<br />

Precimed is the exclusive distributor for the MBBS technology to the<br />

orthopaedic industry worldwide. RFID tags, ready to program, are<br />

available for incorporation on many Precimed instruments, including<br />

acetabular reamers and reamer handles, torque limiting devices,<br />

trays and kits, as well as most standard orthopaedic instruments.<br />

Instruments already in the field can be retrofitted with tags. Pilot<br />

studies are currently being conducted. Individual test programs or<br />

full-scale production can be easily set up to address specific needs by<br />

contacting Precimed directly.<br />

Barbara Lyons is Director of Global Marketing at Precimed in<br />

Exton, Pennsylvania. She can be reached at b.lyons@precimed.com.<br />

Precimed, Inc.<br />

102 Pickering Way, Suite 508<br />

Exton, PA 19341 USA<br />

610-524-8300 (phone)<br />

Web site: www.precimed.com<br />

E-mail: precimed_usa@precimed.com<br />

PINNACLE TECHNOLOGIES<br />

Robotic Cells for Abrasive Belt Polishing, Deburring<br />

and Buffing of Orthopaedic Components<br />

* Off-Line Programming<br />

* Specialists in Cycle Time reduction<br />

* Skilled programmers and technicians<br />

* Laser part recognition<br />

* Concept, Implementation & Training<br />

* Reliable system, user friendly<br />

* New Calibration Software<br />

Full Line Robotics, Robotics, Buffs, Compounds, Compounds, Lubricants, Lubricants,<br />

Spray Guns and Contact Contact Wheels<br />

Wheels<br />

FREE CONSULTATION.<br />

Call Bob Penque at<br />

201-891-7049 Ext. 301<br />

PinnacleTechnologies Inc.<br />

681 Lawlins Road, Bay 140<br />

Wyckoff, New Jersey 07481<br />

Also visit www.CoolitLube.com


PRECISION METAL PRODUCTS, INC.<br />

SIMPLY THE BEST<br />

ORTHOPEDIC IMPLANT MANUFACTURING<br />

• NET & NEAR-NET FORGING - MACHINING - FINISHING•<br />

•<br />

•<br />

•<br />

•<br />

•<br />

At PMP we do it all - your way - to your exacting<br />

specifications, to your schedules and to your<br />

cost targets.<br />

We bring to bear the latest forging and<br />

machining technologies together with the<br />

finest craftsmanship to ensure your total<br />

satisfaction.<br />

Our quality system is certified to ISO 9001:2000<br />

Our customer commitment is unparalleled.<br />

Our long-standing reputation for quality,<br />

reliability and service is unmatched.<br />

Learn why more and more orthopedic implant<br />

OEMs are turning to PMP.<br />

Contact Ross Worthington, Vice President & COO<br />

Voice: 619.448.2711, Ext. 111<br />

Fax: 619.448.2005<br />

email: Rossw@pmp-elcajon.com.<br />

PRECISION METAL PRODUCTS, INC.<br />

EXPERIENCE - DIVERSITY- GROWTH THROUGH INNOVATION SINCE 1963<br />

850 W. BRADLEY AVENUE • EL CAJON, CA 92020<br />

Phone: 619-448-2711 • Fax: 619-448-2005<br />

www.pmp-elcajon.com


FORWARD LOOKING<br />

<<br />

<<br />

Where we’ve been<br />

Where we’re going<br />

For a comfortable, slip-proof grip our patented<br />

Contour Ortho-Grip ® silicone handle.<br />

Today with the financial support and resources of their parent company, Teleflex Medical*, Beere and KMedic are positioned to become<br />

your one source of orthopedic and spinal instruments. *Teleflex Medical is the medical group of Teleflex Inc., a global diversified company with annual revenues that exceed $2 billion.<br />

Partner with Beere at www.beeremedical.com To learn more about Teleflex Medical at www.teleflexmedicaloem.com


LOOKING FORWARD<br />

Where we’ve been<br />

Where we’re going<br />

For minimally invasive spinal procedures,<br />

our Titanium aluminum nitride-coated<br />

Bayonet Cup Curette.<br />

Today with the financial support and resources of their parent company, Teleflex Medical*, KMedic and Beere are positioned to become<br />

your one source of orthopedic and spinal instruments. *Teleflex Medical is the medical group of Teleflex Inc., a global diversified company with annual revenues that exceed $2 billion.<br />

Partner with KMedic at www.kmedicoem.com To learn more about Teleflex Medical at www.teleflexmedicaloem.com<br />

<<br />


AA-AE<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

1006 West 15th Street<br />

Riviera Beach, FL 33404<br />

USA<br />

561-842-7175 (phone)<br />

561-842-7119 (fax)<br />

msales@3d-machining.com<br />

www.3d-machining.com<br />

811 Northwoods Boulevard<br />

PO Box 428<br />

Vandalia, OH 45377<br />

USA<br />

937-387-0300 (phone)<br />

937-387-0305 (fax)<br />

info@afleis.com<br />

www.afleis.com<br />

100 Fordham Road<br />

Building C<br />

Wilmington, MA 01887<br />

USA<br />

866-899-1392 (phone)<br />

978-657-0034 (fax)<br />

info@accellent.com<br />

www.accellent.com<br />

28 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

3-D Machining, Inc. — Player MM MN<br />

9799 D Princeton-Glendale Road<br />

Cincinnati, OH 45246<br />

USA<br />

Medical Device Manufacturing & Engineering. A manufacturer of high<br />

precision machined medical device components, Orthopaedic<br />

Drills, Reamers, Taps and Instruments. We specialize in materials<br />

(titanium, aluminum, S.S., precious metal and plastic) that demand<br />

close tolerance and superior cosmetic finishing. Providing engineering<br />

and design assistance for medical implants, devices and electromechanical<br />

assemblies. ISO 13485:2003.<br />

A. F. Leis Co., Inc. — Player MM MN<br />

4240 North Atlantic Boulevard<br />

Auburn Hills, MI 48326<br />

USA<br />

248-393-7300 (phone)<br />

248-393-4060 (fax)<br />

acme@acmemfg.com<br />

www.acmemfg.com<br />

100 Passaic Avenue<br />

Chatham, NJ 07928<br />

USA<br />

A.F. Leis is a world class and worldwide provider of implants and<br />

instrumentation to the orthopaedic and spinal community. A.F. Leis<br />

has a proven history, a current and comprehensive understanding of<br />

today’s OEM medical needs and a vision for future developments.<br />

We remain focused on helping our customers stay on time, on spec<br />

and within budget. Complete integration of lean manufacturing.<br />

Come visit our brand new state of the art manufacturing facility.<br />

ISO 9001:2000 certified, FDA registered.<br />

Accellent — Player AT DS FO LP MM MN PA RM ST YY<br />

Accutek Testing Laboratory, Inc. AT<br />

Rastatter Str. 15<br />

Pforzheim, 75179<br />

Germany<br />

5717 West Minnesota Street<br />

Indianapolis, IN 46241<br />

USA<br />

Outsourcing Solutions for the Orthopaedic Market. Accellent provides<br />

a comprehensive menu of solutions, including design and<br />

engineering, precision component fabrication, finished device<br />

assembly and complete supply chain management. Orthopaedic and<br />

Endoscopy divisions develop, manufacture and assemble implants<br />

and instruments for the reconstructive, spinal, trauma, sports medicine<br />

and minimally invasive surgery segments. ISO 13485:2003;<br />

ISO 13485; QSR 21 CFR 820 Certified.<br />

513-984-4112 (phone)<br />

513-984-8258 (fax)<br />

Acme Manufacturing Company — Player MT<br />

Integrated Robotic Polishing, Grinding & Buffing Systems for<br />

Orthopaedic Components. Largest global manufacturer of robotic<br />

gate grinding and finishing systems. Our expertise is focused on<br />

providing a complete fully developed risk-free finishing system to<br />

support the global medical implant industry. In-house technical support<br />

staff of engineers for: applications, product and electrical controls,<br />

off-line programming and training. QS-9000 TE Supplement<br />

Certified.<br />

011-49-7231-9223-121 (phone)<br />

011-49-7231-9223-198 (fax)<br />

973-635-9040 (phone)<br />

877-257-9040 (toll free)<br />

973-635-9878 (fax)<br />

317-246-5535 (phone)<br />

888-625-4497 (toll free)<br />

317-246-5544 (fax)<br />

atli@fuse.net<br />

www.accutektesting.com<br />

Admedes Schuessler GmbH LP MM SP ST<br />

Advanced Biomaterial Systems, Inc. DS MM MN<br />

Advantis Medical, Inc. DS<br />

AeroMed, Inc. MM MN<br />

2342 North Penn Road<br />

Hatfield, PA 19440<br />

USA<br />

215-997-2900 (phone)<br />

215-997-0165 (fax)<br />

info@admedes.com<br />

www.admedes.com<br />

mcarr@advbiomat.com<br />

www.advbiomat.com<br />

jspencer@advantismedical.com<br />

www.advantismedical.com<br />

nstorer@aerom.com<br />

www.aerom.com


Integrated Robotic Polishing, Grinding and<br />

Buffing Systems for Orthopaedic Components<br />

Acme Manufacturing Company is the largest and most experienced global manufacturer<br />

of robotic polishing, gate grinding, deburring and buffing systems for orthopaedic<br />

components. Over 70 systems in production worldwide.<br />

Applications<br />

• Knees, Hips, Tibia Trays, Cups, Bone Plates, Instruments<br />

• Cobalt Chrome, Titanium, Stainless Steel, Zirconium<br />

• Casting Tree Cut-Off<br />

• Gate Grind<br />

• Forged Flash Removal<br />

• Rough Out and Finish Belt Polish<br />

• Cup and ball buffing<br />

• Deburring<br />

Features and Benefits<br />

Robotic Polishing, Grinding and Buffing Systems<br />

• Turn Key System Design & Build<br />

• Part Validation Capability<br />

• Universal Tooling Concepts<br />

• Field Proven Process Knowledge<br />

• Process Control Monitor and Automatic Adjustment<br />

• Vision Inspection with Automatic Process Modification<br />

• Heat Reduction Process Control Technology<br />

• Media Life Management and Control<br />

• Troubleshooting Via Modem and/or Internet<br />

• Ethernet Host Computer Support<br />

• Built to RIA and CE Specifications<br />

• Reduced Labor to Finish Femoral Components<br />

• Integrated Dust Collection<br />

• Acme RoboGuide Robotic Offline Programming<br />

• Unattended Run Time with Custom Part Queuing Options<br />

• Reduced Media Usage by 4-6 Times over Manual Finishing<br />

• Return on Investment in 1-Year or Less<br />

• On Demand Quick Set Up and Change Over Capability<br />

• Force Controlled Finishing Heads with Variable Speed<br />

Spindle Motors<br />

Acme’s expertise is focused on providing a complete fully developed and risk-free<br />

finishing system to support the medical implant industry worldwide.<br />

Acme maintains a complete in-house technical support staff of engineers for: applications,<br />

product, and electrical controls, off-line programming and training. Our service<br />

technicians provide start up, installation support, hands on training, part task programming<br />

and trouble shooting worldwide.<br />

Player Profile<br />

Acme Manufacturing Company<br />

4240 North Atlantic Boulevard<br />

Auburn Hills, MI 48326<br />

USA<br />

248-393-7300 (phone)<br />

248-393-4060 (fax)<br />

acme@acmemfg.com<br />

Web site<br />

www.acmemfg.com<br />

Founded<br />

1910<br />

Contacts<br />

Glen A. Carlson, Jr.<br />

Chairman<br />

Glen A. (Fritz) Carlson III<br />

President<br />

Joe Saad<br />

Director of Sales<br />

Robotic Systems Staff<br />

Paul F. Miekstyn<br />

Sr. Product Manager<br />

Jack Karagozian<br />

Sr. Product Manager<br />

Charles Young<br />

Sr. Product Manager<br />

Marcus E. Armstead<br />

Director of Electrical Engineering<br />

Facilities<br />

50,000 sq. ft.<br />

Staff<br />

75 employees<br />

Certification<br />

QS-9000 TE Supplement<br />

BONEZone • Winter 2005 29


AN-BC<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

2020 Ashcraft Avenue<br />

PO Box 5030<br />

Monroe, NC 28110<br />

USA<br />

704-289-4511 (phone)<br />

800-537-5551 (toll free)<br />

704-289-4018 (fax)<br />

sales@allvac.com<br />

www.allvac.com<br />

126 West North Main Street<br />

PO Box 537<br />

Flatonia, TX 78941<br />

USA<br />

361-865-3300 (phone)<br />

877-912-8740 (toll free)<br />

361-865-2611 (fax)<br />

bargasmed@techisp.com<br />

www.bargasmedical.com<br />

1393 Progress Way, Suite 903<br />

Eldersburg, MD 21784<br />

USA<br />

30 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

Anzon Co. MM MN<br />

12326 Denholm Drive<br />

El Monte, CA 91732<br />

USA<br />

APS Materials, Inc. ST<br />

4011 Riverside Drive<br />

Dayton, OH 45405<br />

USA<br />

ASTRO Medical Devices CP MM MN<br />

7124 Industrial Park Boulevard<br />

Mentor, OH 44060<br />

USA<br />

1120 D.I. Drive<br />

Elkhart, IN 46514<br />

USA<br />

626-443-8861 (phone)<br />

626-575-0311 (fax)<br />

937-278-6547 (phone)<br />

937-278-4352 (fax)<br />

440-269-6984 (phone)<br />

440-602-6091 (fax)<br />

ATI Allvac — Player RM<br />

Metallic Biomaterials. Nickel-base and cobalt-base superalloys, titanium-base<br />

alloys and specialty steels characterized by exceptional<br />

wear, corrosion and heat resistance, toughness and strength. Metals<br />

and alloys available in most product forms: ingot, billet, slab, hotrolled<br />

round bar, rectangular bar, custom shapes, cold-drawn round<br />

bar, coiled rod and hot-rolled, cold-rolled or cold drawn wire.<br />

ISO 9001:2000, AS9100 Certified.<br />

Medical Device Fabrication. Provider of services for Medical Devices<br />

in support of R&D, custom products and production efforts.<br />

Technological expertise to present you with the best possible solution<br />

for solving your manufacturing challenges. We are ready to do<br />

what it takes to provide rapid response and to meet the changing<br />

needs of our customers and markets. Medical Devices are our only<br />

business. FDA Registered.<br />

574-264-3997 (phone)<br />

888-941-3997 (toll free)<br />

574-262-8937 (fax)<br />

BCS Machine Company Inc. MM MN<br />

410-552-5452 (phone)<br />

410-552-5480 (fax)<br />

gbetz27@aol.com<br />

leog@apsmaterials.com<br />

www.apsmaterials.com<br />

bhall@astromodel.com<br />

www.astromedical.com<br />

Atlas Vac Machine, Div. of Planet Products MT<br />

4200 Malsbary Road<br />

Cincinnati, OH 45242<br />

USA<br />

Automation Design Engineering, Inc. LP MT<br />

110 South Railroad Avenue<br />

New Holland, PA 17557<br />

USA<br />

513-984-5544 (phone)<br />

513-984-5580 (fax)<br />

215-290-4096 (phone)<br />

717-354-2584 (fax)<br />

Bargas Medical Mfg., Inc. — Player MM MN SO<br />

Bates Machine, Inc. MM MN<br />

jabraham@planet-products.com<br />

www.atlasvac.com<br />

bmadden@autodesigneng.com<br />

www.autodesigneng.com<br />

Sales@BatesMachine.com<br />

www.orthosupplier.com/profiles/<br />

bates-machine2.htm<br />

info@bcsmachine.com<br />

www.bcsmachine.com


Medical Device Manufacturing & Engineering<br />

Specializing in Orthopaedic Implants, Fixation Devices,<br />

Drills, Reamers, Taps and Specialty Instruments.<br />

3-D is owned and operated by the<br />

Davis brothers Jim and Joe,<br />

founders of Micro Med Machining<br />

and Impla-Med.<br />

<strong>The</strong> Davis brothers have been<br />

manufacturing medical device<br />

assemblies and components for<br />

over 24 years. In their newest<br />

venture, 3-D Machining, they join<br />

their father in a world-class medical<br />

manufacturing environment.<br />

Manufacturing Capabilities<br />

• CNC Multi-Axis Swiss<br />

• CNC 4 Axis Milling Vertical & Horizontal<br />

• Rollomatic CNC 8 Axis Drill Grinders / robot loader<br />

• O.D. / I.D. Grinding<br />

• Laser Etch<br />

• Proprietary finishing processes<br />

• Precision Cleaning<br />

• Passivation<br />

We pride ourselves on Superior<br />

Quality, Competitive Pricing, and<br />

we operate under a Quality system<br />

certified to ISO 13485 and<br />

ISO 9001:2000.<br />

Our Focus<br />

• medical implants and<br />

instruments<br />

• rotary cutting instruments<br />

• complex medical device<br />

assemblies<br />

Player Profile<br />

3-D Machining, Inc.<br />

1006 West 15th Street<br />

Riviera Beach, FL 33404<br />

USA<br />

561-842-7175 (phone)<br />

561-842-7119 (fax)<br />

Web site<br />

www.3d-machining.com<br />

Founded<br />

1950<br />

Contacts<br />

Joe Davis<br />

msales@3d-machining.com<br />

Facility<br />

40,000 sq. ft.<br />

Staff<br />

85 employees<br />

Certification<br />

ISO 13485:2003<br />

BONEZone • Winter 2005 31


BE-BR<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

5307 95th Avenue<br />

Kenosha, WI 53144<br />

USA<br />

262-657-2800 (phone)<br />

800-295-8505 (toll free)<br />

262-657-2801 (fax)<br />

info@beeremedical.com<br />

www.beeremedical.com<br />

21316 Bridge Street<br />

Southfield, MI 48034<br />

USA<br />

248-350-2150 (phone)<br />

248-350-1557 (fax)<br />

info@porouscoat.com<br />

www.porouscoat.com<br />

9 North Main Street<br />

Jamestown, NY 14702<br />

USA<br />

716-665-2340 (phone)<br />

800-766-6606 (toll free)<br />

716-665-2480 (fax)<br />

wchiarella@blackstone-ney.com<br />

www.blackstone-ney.com<br />

32 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

Beere Medical — Player MN<br />

1 Tong Street<br />

Bradford BD4 9PW<br />

U.K.<br />

Design, development and manufacture of innovative spinal and<br />

orthopedic surgical instruments. As an approved supplier to many<br />

of the world’s largest orthopedic and spinal companies, Beere<br />

partners with customers to jointly develop and manufacture state<br />

of the art instrumentation to meet their most demanding requirements.<br />

FDA registered, ISO 9001:2000 registered, with EN46001<br />

and ISO 13485.<br />

BENSOL, Inc. YY<br />

PO Box 861<br />

Warsaw, IN 46851<br />

USA<br />

41 Eagle Road<br />

Danbury, CT 06810<br />

USA<br />

574-834-4139 (phone)<br />

574-834-4139 (fax)<br />

Bio-Vac, USA / Bio-Coat Inc. — Player ST<br />

Unique Solutions for Implant Fixation. Surface Treatments. Porous<br />

Coating (spherical bead & irregular particle). A range of morphologies<br />

in titanium and CoCrMo alloys. Hydroxylapatite Coating.<br />

Titanium Plasma Spray Coating. Resorbable Blast Media Coating.<br />

Composite Coatings. Our services are confined to the medical<br />

implant field. Cross-contamination of foreign materials and dilution<br />

of resources are never an issue. ISO 9001:2000.<br />

Blackstone — NEY Ultrasonics — Player MT SP ST<br />

Your Global Partner in Cleaning Innovation. Innovative processes,<br />

state-of-the-art parts cleaning systems are our specialty. Our customers<br />

are the leaders in manufacturing speciality surgical, medical<br />

and orthopedic products and devices. We have over 50 years of<br />

experience in the design and manufacturing of high performance<br />

ultrasonic cleaning equipment to the medical industry. Our systems<br />

are FDA Compliant and process validated.<br />

Boston Endo-Surgical Technologies Inc. MM MN<br />

Bradford Tool Group AT CP MN MT SP ST<br />

011-44-1274-683902 (phone)<br />

011-44-1274-651168 (fax)<br />

203-796-0461 (phone)<br />

203-796-0535 (fax)<br />

www.orthosupplier.com/profiles/bensol2.htm<br />

Boston Centerless — Player RM<br />

11 Presidential Way<br />

Woburn, MA 01801<br />

USA<br />

781-994-5000 (phone)<br />

800-343-4111 (toll free)<br />

781-994-5001 (fax)<br />

info@bostoncenterless.com<br />

www.bostoncenterless.com<br />

Drakes River Business Park<br />

8 Merrill Drive<br />

Hampton, NH 03842<br />

USA<br />

Single Source Material <strong>Supplier</strong>. Providing high quality precision<br />

ground bars with unmatched consistency of roundness, straightness<br />

and size tolerance. In-stock materials include stainless steel, titanium<br />

and various medical alloys utilized for implants and instrumentation.<br />

Additional capabilities: straightening, chamfering, heat-treating<br />

and cut piece processing. Grinding services on customer materials<br />

also. ISO 9001:2000 certified.<br />

603-929-0066 (phone)<br />

603-929-0088 (fax)<br />

info@be-st.com<br />

www.be-st.com<br />

bradtool@btinternet.com<br />

www.bradtool.co.uk<br />

Branson Ultrasonics MT SP ST<br />

jhilgert@bransonultrasonics.com<br />

www.bransonultrasonics.com<br />

Britton-Gallagher & Associates, Inc. YY<br />

6240 SOM Center Road<br />

Cleveland, OH 44139-2985<br />

USA<br />

440-264-2703 (phone)<br />

800-607-4711 (toll free)<br />

440-248-5406 (fax)<br />

michael_cremeans@britton-gallagher.com<br />

www.britton-gallagher.com


Innovative Instrument Design, Quality and Manufacturing<br />

Beere, an industry leader of new and innovative surgical instruments, is an approved supplier to<br />

many of the world’s largest orthopedic and spinal companies.<br />

By partnering with our customers, we are able to jointly develop and manufacture state of the art<br />

instrumentation to meet their most demanding requirements. Beere exemplifies quality manufacturing,<br />

customer service and innovative product design in spinal and orthopedic instrumentation.<br />

Design, Development and Manufacturing Capabilities<br />

Each Beere Medical instrument is put through extensive research and development analysis. After<br />

design criteria and performance standards have been determined, we utilize the latest 3D CAD<br />

modeling software to develop your product.<br />

Wherever possible, products are developed in cooperation with the surgeon’s input. <strong>The</strong> goal of<br />

Beere Medical’s team is to seek to design, develop and manufacture highly innovative and favorable<br />

instruments. As a result, our design team has been awarded over 30 U.S. patents with additional<br />

patents pending. Our ability to supply standard order, special order, and custom order instruments<br />

is our ultimate objective.<br />

We offer full service prototyping, pilot and production builds to meet your most demanding needs.<br />

High quality autoclaveable, medical-grade materialas available are used. <strong>The</strong>se materials are certified<br />

with full traceability in the finest grades of stainless steel, titanium, aluminum, super alloys,<br />

silicone and plastic. Manufacturing capabilities consist of multi axis CNC machining and turning<br />

centers, Swiss type multi axis CNC turning centers, CNC grinding, CNC robotics, wire and ram EDM<br />

equipment, laser marking, electro chemical etching, tool room, welding, soldering, brazing, stamping,<br />

bending, honing, and broaching.<br />

Instruments are manufactured in our 66,000 square foot<br />

manufacturing facility in Kenosha, Wisconsin.<br />

Services<br />

• Custom and special order capabilities<br />

• Value-added engineering<br />

• Video conferencing to enhance communications with customers<br />

• Dock-to-stock packaging and labeling<br />

• Instrument supply chain management<br />

66,000 square foot facility<br />

Quality<br />

At Beere, quality is instilled into every instrument we produce. Beere’s Quality Systems are<br />

certified to:<br />

• ISO 9001:2000<br />

• EN46001<br />

• ISO 13485<br />

Products<br />

• Ortho-Grip®: <strong>The</strong> “original,” patented, silicone rubber handles that revolutionized the orthopedic<br />

community. More than 100 different shapes and variations available.<br />

• Tru-Control® Ratcheting Screwdriver: <strong>The</strong> leading, patent pending, ultra-precise ratcheting screw<br />

driver offers comfort and optimum quality. Designed and manufactured to industry standards.<br />

• Evolution Spinal Implant Removal Kit: This patented universal instrument set will remove most<br />

of the spinal implants in the market today. <strong>The</strong> only spinal implant removal kit designed in conjunction<br />

with the major implant companies.<br />

• Torque instruments: Offering a wide variety of variable torque limiting devices, in addition to an<br />

extensive line of standard torque limiting and measuring instruments.<br />

• Spinal instruments: Meeting today’s spinal instrument needs and expectations in the orthopedic<br />

industry.<br />

• Custom Instruments: Our complete “In-house” manufacturing capabilities are ready to produce<br />

instruments that meet your most challenging requirements.<br />

We invite you to contact us to see how we can provide custom solutions to your challenges.<br />

Player Profile<br />

Beere Medical<br />

A Teleflex Medical Company<br />

5307 95th Avenue<br />

Kenosha, WI 53144<br />

USA<br />

262-657-2800 (phone)<br />

800-295-8505 (toll-free)<br />

262-657-2801 (fax)<br />

Web site<br />

www.teleflexmedicaloem.com<br />

Contacts<br />

Douglas Slomski<br />

Sales Director<br />

Teleflex Medical OEM Orthopedics<br />

dslomski@teleflexmedical.com<br />

Keith Easter<br />

Director of Inside Sales & Service<br />

keaster@teleflexmedical.com<br />

Greg Kitchens<br />

Central States Sales Contact<br />

gkitchens@teleflexmedical.com<br />

Steve Pubols<br />

West Coast Sales Contact<br />

spubols@teleflexmedical.com<br />

Armin Grab<br />

European Sales Contact<br />

armin.grab@teleflexmedical.com<br />

Founded<br />

1993<br />

Focus<br />

Spinal surgical instruments<br />

Background<br />

Founded in 1993, through innovative product<br />

design, on-time delivery and competitive<br />

pricing, Beere is an industry leader of<br />

new surgical instruments.<br />

In 2002, Beere became part of Teleflex<br />

Medical, a division of Teleflex Incorporated<br />

(NYSE: TFX), a worldwide leader in the<br />

design, manufacturing and distribution of<br />

high-quality engineered surgical instruments,<br />

medical devices and healthcare<br />

supplies.<br />

In 2003, Beere and KMedic joined together<br />

as Teleflex Medical OEM Orthopedics to<br />

provide a single source for customers’<br />

instrument needs.<br />

In 2005, Beere and KMedic US are located<br />

in the same facility in Kenosha, WI.<br />

BONEZone • Winter 2005 33


C-CH<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

2 Meridian Boulevard<br />

Wyomissing, PA 19610<br />

USA<br />

610-208-2000 (phone)<br />

610-208-3716 (fax)<br />

mspeers@cartech.com<br />

www.cartech.com<br />

34 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

C & W Swiss Inc. MM MN<br />

PO Box 65<br />

1695 Dalton Drive<br />

New Carlisle, OH 45344<br />

USA<br />

542 East CR 200 North<br />

Warsaw, IN 46582<br />

USA<br />

2875 Lincoln Street<br />

Muskegon, MI 49443<br />

USA<br />

937-849-9556 (phone)<br />

937-849-9562 (fax)<br />

C.O.R.E.tech, Inc. MM MN<br />

574-267-5744 (phone)<br />

574-267-5856 (fax)<br />

231-755-1681 (phone)<br />

800-253-0371 (toll free)<br />

231-755-4975 (fax)<br />

Carpenter Technology Corporation — Player RM<br />

Material Solutions for the Orthopaedic Industry. Our stainless steel,<br />

titanium and engineered products have been used in hundreds of<br />

applications, from industrial tools and jet engines to fuel injectors<br />

and medical implants. Our materials and components are known for<br />

their dependability, strength, toughness, corrosion resistance and<br />

ability to withstand high temperatures. Carpenter Specialty Alloys<br />

ISO 9001:2000 Certified.<br />

rreynolds@coretech-inc.com<br />

www.coretech-inc.com<br />

Cannon-Muskegon Corporation RM<br />

Carr Metal Products DS<br />

3735 North Arlington Avenue<br />

Indianapolis, IN 46218-1867<br />

USA<br />

Cencast LLC CA<br />

5476 SE International Way<br />

Portland, OR 97222<br />

USA<br />

503-652-5224 (phone)<br />

503-652-6152 (fax)<br />

Centex Machining, Inc. — Player MM MN<br />

1513 Sam Bass Road<br />

Round Rock, TX 78681<br />

USA<br />

512-255-1477 (phone)<br />

512-388-3606 (fax)<br />

pmangan@centexmachining.com<br />

www.centexmachining.com<br />

Manufacturing Support for the Orthopaedic Industry. Exclusive manufacturing<br />

support for U.S. orthopaedic companies. Customer design<br />

collaboration and new product launches are our specialty. We realize<br />

the importance of being a market leader, and we’ll dedicate<br />

whatever resources are required to ensure that your new product<br />

launch comes off without a hitch. Hips, knees, shoulders, spinal<br />

devices. Implants, provisionals & instruments. FDA-registered.<br />

Chapman Lake Instrument Corp. MN<br />

2115 Industrial Drive<br />

Bloomington, IN 47404<br />

USA<br />

115 Milvan Drive<br />

Toronto, Ontario M9L1Z8<br />

Canada<br />

39 Dedham Street<br />

Sharon, MA 02067-1011<br />

USA<br />

317-542-0691 (phone)<br />

317-542-0694 (fax)<br />

812-323-7165 (phone)<br />

812-323-2115 (fax)<br />

Charlton Medical Products, Inc. MM MN<br />

416-741-9030 (phone)<br />

416-741-0995 or 9004 (fax)<br />

781-784-8452 (phone)<br />

781-784-0425 (fax)<br />

info@cwswiss.com<br />

www.cwswiss.com<br />

jkiely@canmkg.com<br />

www.c-mgroup.com<br />

bernieberry@cmp-inc.com<br />

www.leispartners.com/cmp.htm<br />

timhall@cencasters.com<br />

www.cencasters.com<br />

mkiser@chapmanlakeinstrument.com<br />

www.chapmanlakeinstrument.com<br />

johnsr@charltons.com<br />

www.charltons.com<br />

Chen Consulting, Inc. YY<br />

elizabeth@chenconsulting.com


Accelerating the Speed of Medical Innovation<br />

Accellent offers the most comprehensive menu of outsourcing<br />

solutions to the medical device market, including design and<br />

engineering services, precision component production, finished<br />

device assembly and complete supply chain management.<br />

In our Orthopaedics Division, we develop, manufacture and<br />

assemble implants and instruments for the reconstructive, spinal,<br />

trauma and sports medicine segments. Our capabilities are<br />

enhanced by a new state of the art robotic forging facility, as well<br />

as our proprietary CHEMTEX® surface treatment to facilitate bone<br />

in-growth. With multiple manufacturing sites and hundreds of CNC<br />

machines, Accellent has the scale and resources to simplify your<br />

supply chain.<br />

Markets Served Implants and Instruments<br />

Joint Reconstruction<br />

Implants Hips, Knees, Extremities<br />

Trauma<br />

Implants Plates, Bone Screws<br />

Spinal<br />

Implants Artificial Discs, Fixation Plates,<br />

Pedicle Screws, Rods, Cages, Hooks,<br />

Cross Connectors<br />

Dental<br />

Implants Abuttments, Screws<br />

Sports Medicine Screws, RF Ablation, Arthroscopy<br />

Orthobiologics Single-use Delivery Devices, Mixing<br />

Systems, Machined Implants<br />

Instruments Trials, Minimally Invasive Surgery,<br />

Computer Assisted Surgery, Impactors,<br />

Cutting Blocks, Tamps, Screwdrivers, Drills,<br />

Taps, Reamers, Catheters, Guidewires<br />

Player Profile<br />

Accellent Orthopaedics<br />

100 Fordham Road, Building C<br />

Wilmington, MA 01887<br />

USA<br />

866-899-1392 (phone)<br />

978-657-0034 (fax)<br />

info@accellent.com<br />

Web site<br />

www.accellent.com<br />

Contact<br />

Tom Burns<br />

Vice President, Sales<br />

Orthopaedics Division<br />

Tom.Burns@accellent.com<br />

Facility<br />

Engineering, manufacturing and<br />

device assembly facilities in the<br />

U.S., Mexico and Ireland<br />

Staff<br />

3,900 employees<br />

Certifications<br />

ISO 13485:2003; ISO 13485;<br />

QSR 21 CFR 820<br />

BONEZone • Winter 2005 35


CL-DA<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

2730 Independence Drive<br />

Fort Wayne, IN 46808<br />

USA<br />

260-483-1110 (phone)<br />

260-484-0368 (fax)<br />

sales@cuttingsolutions.net<br />

www.cuttingsolutions.net<br />

36 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

Classic Wire Cut Company, Inc. MM MN<br />

25014 Anza Drive<br />

Valencia, CA 91355<br />

USA<br />

Clinical Research Consultants, Inc. YY<br />

310 Terrace Avenue<br />

Suite 201<br />

Cincinnati, OH 45220<br />

USA<br />

125 Old Gate Lane<br />

Milford, CT 06460<br />

USA<br />

513-961-8200 (phone)<br />

516-961-2858 (fax)<br />

203-874-6500 (phone)<br />

800-262-7763 (toll free)<br />

203-874-6505 (fax)<br />

Service as Sharp as Our Tools. A one stop solution for all your cutting<br />

needs “Metal to Bone,” whether you need metal cutting tools<br />

or orthopaedic instruments. One of the first companies in the U.S.<br />

to CNC grind a hip broach. Established in 1948, Cutting Solutions<br />

offers over 50 years of service to the orthopaedic and metal cutting<br />

industries with a veteran foundation of experience. Solutions from<br />

concepts to design assistance, prototypes and production. ISO<br />

9001:2000, ISO 13485 compliant, registration 4Q05, FDA registered.<br />

bsfant@crc-regulatory.com<br />

www.crc-regulatory.com<br />

Composition Materials Co., Inc. MT SP<br />

20 Federal Street<br />

West Gartford, CT 06110<br />

USA<br />

661-257-0558 (phone)<br />

661-257-3410 (fax)<br />

860-570-0616 (phone)<br />

860-570-0616 (fax)<br />

btopper@classicwirecut.com<br />

www.classicwirecut.com<br />

akn@compomat.com<br />

www.compomat.com<br />

Contour Tool Inc. MN MT<br />

588 Ternes Avenue<br />

Elyria, OH 44035<br />

USA<br />

224 Beacon Hill Drive<br />

Cheshire, CT 06410<br />

USA<br />

440-365-7333 (phone)<br />

440-365-7335 (fax)<br />

Creative Management Solutions, Inc. MR<br />

tcomet@snet.net<br />

www.orthosupplier.com/profiles/creativemanagement-solutions2.htm<br />

Creative Orthopaedics, LLC YY<br />

Creganna Medical Devices DS LP<br />

Parkmore West<br />

Galway,<br />

Ireland<br />

5349 West 161st Street<br />

Brook Park, OH 44142<br />

USA<br />

preichlin@contourtool.com<br />

www.contourtool.com<br />

203-699-8475 (phone) john@creativeorthopaedics.com<br />

www.creativeorthopaedics.com<br />

+353-91-735231 (phone)<br />

+353-91-757850 (fax)<br />

Criterion Instrument/Criterion Tool & Die, Inc. MM MN<br />

216-267-1733 (phone)<br />

216-267-4542 (fax)<br />

Cutting Solutions — Player MN<br />

Dameron Alloy Foundries, Inc. CA<br />

927 South Santa Fe Avenue<br />

(90221)<br />

PO Box 8000<br />

Compton, CA 90224<br />

USA<br />

310-631-5165 (phone)<br />

800-421-1985 (toll free)<br />

310-631-0368 (fax)<br />

michael.howe@creganna.com<br />

www.creganna.com<br />

tdisalvo@criteriontool.com<br />

www.criteriontool.com<br />

davebaron@dameron.net<br />

www.dameron.net


20 years of experience in the field of cutting instrumentation for<br />

the Orthopaedic Industry<br />

• Expertise in concept, design, prototyping and production in a wide variety of<br />

medical devices for both Trauma and Reconstructive surgeries.<br />

• In-house manufacturing capabilities of metal cutting tools allowing the ability<br />

to service in-house milling and turning applications, resulting in minimal<br />

down time in both prototyping and production.<br />

• Visual Manufacturing operating systems, allowing for complete traceability<br />

from acknowledgement to shipment.<br />

• Real time scheduling and tracking<br />

• <strong>Supplier</strong> managed inventory<br />

• FDA Registered<br />

Service as Sharp as Our Tools<br />

• ISO 9001:2000 and ISO 13485 certified 4th quarter 2005<br />

Complete product verification before ever cutting a chip through<br />

Unigraphics, Solid Works, Master Cam and Vericut.<br />

• Live turning with profile capability up to 4” in diameter<br />

• Milling capability up to 40” x 25” x 25”<br />

• 20,000 rpm high speed milling up to 16” x 12” x 10”<br />

• All mills equipped with Renishaw part probe capability<br />

• Vacuum Heat Treating with no discoloration to parts<br />

• Multi-axis grinding up to 20” in length x 10” in diameter<br />

• Right or left hand helix, left hand helix right hand cut<br />

• Digitize part capability to orient flutes, profiles and coolant holes<br />

• Laser welding, coating, cleaning, passivation, electro polishing and<br />

glass beading<br />

Player Profile<br />

Cutting Solutions<br />

2730 Independence Drive<br />

Fort Wayne, IN 46808<br />

USA<br />

260-483-1110 (phone)<br />

260-484-0368 (fax)<br />

sales@cuttingsolutions.net<br />

Web site<br />

www.cuttingsolutions.net<br />

Contact<br />

Brent Weisenauer<br />

Vice President<br />

brent@cuttingsolutions.net<br />

Facility<br />

8,000 sq. ft.<br />

Staff<br />

17 employees<br />

Certifications<br />

ISO 9001:2000<br />

ISO 13485 compliant,<br />

registration 4Q05<br />

FDA registered<br />

BONEZone • Winter 2005 37


DA-DU<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

PO Box 126<br />

80 Portland Street<br />

Fryeburg, ME 04037<br />

USA<br />

38 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

Danco Metal Finishing ST<br />

44 La Porte Street<br />

PO Box 660727<br />

Arcadia, CA 91006<br />

USA<br />

1 Herald Square<br />

Fairborn, OH 45324<br />

USA<br />

626-445-3303 (phone)<br />

626-445-3135 (fax)<br />

Dearborn Precision Tubular MM MN<br />

207-935-2171 (phone)<br />

207-935-2908 (fax)<br />

DEW Technologies, Inc. MM<br />

937-878-7001 (phone)<br />

937-878-7106 (fax)<br />

DiSanto Technology, Inc. MM MN<br />

72 Camp Avenue<br />

Stamford, CT 06907<br />

USA<br />

203-595-0056 (phone)<br />

203-595-0058 (fax)<br />

Disposable Instrument Co., Inc. MM MN<br />

PO Box 14248<br />

Shawnee Mission, KS 66285-4248<br />

USA<br />

13963 Fir Street<br />

PO Box 1990<br />

Oregon City, OR 97045-0043<br />

USA<br />

503-656-9653 (phone)<br />

503-656-1788 (fax)<br />

medicalamerica@doncasters.com<br />

www.doncasters.com<br />

Charles-Darwin-Ring 1a<br />

D-18059 Rostock, Mecklenburg-<br />

Vorpommern<br />

Germany<br />

Casting, Forging and Finishing. Doncasters Medical Technologies is<br />

the market leader in investment cast orthopaedic products and supplies<br />

orthopaedic instrumentation, near net-shaped forgings and finishing<br />

operations. Offering total raw material supply, the company<br />

manufactures a wide range of medical devices from generic endos<br />

through to the latest metal-on-metal resurfacing products. <strong>The</strong> division<br />

encompasses five “pure-play” medical sites in North America,<br />

Mexico and Europe. <strong>The</strong> company’s mission is to assist the medical<br />

device industry in restoring their patients to the quality of life they<br />

desire. For further information, visit our web site. ISO 9001:2000.<br />

+49-381-403350 (phone)<br />

+49-381-4033599 (fax)<br />

anodize@danco.net<br />

www.danco.net<br />

smckinney@dearbornprecision.com<br />

www.dearbornprecision.com<br />

kross@dewtec.com<br />

www.dewtec.com<br />

m.zembrzuski@disanto.com<br />

www.disanto.com<br />

Doncasters Medical Technologies — Player CA FO MM RM<br />

12416 South Kedvale Avenue<br />

Alsip, IL 60803<br />

USA<br />

DRT Mfg. Co. — Player MM MN<br />

61 North Avenue<br />

Natick, MA 01890<br />

USA<br />

913-492-6492 (phone)<br />

913-888-1762 (fax)<br />

Donson Machine Company MM MN<br />

708-388-0880 (phone)<br />

708-388-4003 (fax)<br />

508-653-7900 (phone)<br />

800-274-3388 (toll free)<br />

508-653-7832 (fax)<br />

mail@disposableinstrument.com<br />

www.disposableinstrument.com<br />

joe@donsonmachine.com<br />

www.donsonmachine.com<br />

DOT GmbH MM MN PA ST<br />

618 Greenmount Boulevard<br />

Dayton, OH 45419<br />

USA<br />

937-298-7391 (phone)<br />

937-298-7190 (fax)<br />

cisham@drtusa.com<br />

www.drtusa.com<br />

Ultra-Precision Manufacturing...and More. With advanced manufacturing<br />

technology at our plants in Ohio, South Carolina and Europe,<br />

DRT specializes in machining geometrically challenging details to<br />

tolerances of .0002”. Our capabilities include Wire & Ram EDM,<br />

Swiss Turning, 5-axis precision milling and Jig Grinding. DRT is your<br />

comprehensive solution for challenging manufacturing requirements.<br />

ISO 9001:2000 certified & FDA registered.<br />

zeggel@dot-coating.de<br />

www.dot-coating.de<br />

Duralectra - Fine Aluminum Finishing ST<br />

rmills@duralectra.com<br />

www.duralectra.com


Hower Tool supplies the orthopaedic industry with engineering,<br />

prototyping, manufacturing, packaging complete and inventory<br />

management of trials, implants, instruments, handles, cutting<br />

blocks and assemblies in stainless steel, titanium, cobalt chrome<br />

and a variety of medical grade plastics. We are market focused<br />

and customer driven, utilizing lean techniques to concentrate on<br />

our customer’s total cost of ownership including quality, delivery<br />

and service. We are capable of virtual information transfer and<br />

have a prototype department specifically for quick turn prototype<br />

and make to order requirements. We are currently ISO 9001:2000<br />

certified, FDA Registered and will achieve ISO 13485 certification<br />

in <strong>2006</strong>.<br />

Hower Tool has the expertise, experience and facilities to provide<br />

quick innovative solutions that take your design to specified completion.<br />

We will complement your knowledge of orthopaedics with<br />

our manufacturing expertise to make your design even more<br />

robust, repeatable and economical.<br />

We have improved our leading edge CNC machining capabilities<br />

and capacity by continuing to add new state of the art equipment.<br />

We have also completely furnished our prototype department<br />

with everything needed to take your drawings or models<br />

and quickly produce your prototypes or made to order special<br />

parts.<br />

Process Capabilities<br />

Quick, Innovative, Cost-Effective Solutions<br />

• CNC Turning – Dual spindle/Y axis<br />

• CNC Milling – 5 axis<br />

• EDM – 4 axis<br />

• Specialized Tooling<br />

• Finishing<br />

• Polishing, Blasting<br />

• Passivation<br />

• Laser Etching<br />

• Package Complete<br />

• Fixture Building<br />

• Welding<br />

Player Profile<br />

Hower Tool<br />

6935 North State Road 1<br />

Ossian, IN 44777<br />

USA<br />

260-622-4150 (phone)<br />

260-622-4151 (fax)<br />

sales@howertool.com<br />

Web site<br />

www.howertool.com<br />

Facility<br />

37,000 sq. ft.<br />

Founded<br />

1957<br />

Contacts<br />

Thomas J. Gregory<br />

General Manager<br />

tgregory@howertool.com<br />

Thomas V. Bains<br />

Marketing & Sales Manager<br />

tbains@howertool.com<br />

Jeff D. Gresley<br />

Operations Manager<br />

jgresley@howertool.com<br />

Brian R. Nichols<br />

Quality Manager<br />

bnichols@howertool.com<br />

Staff<br />

46<br />

Registration/Certification<br />

ISO 9001:2000<br />

FDA-Registered<br />

In 1957, Hower Tool began producing<br />

and salvaging specialized<br />

precision carbide tooling. <strong>The</strong><br />

Akron Equipment Company purchased<br />

Hower Tool in 1970 and<br />

began adding state of the art<br />

machining equipment. Hower<br />

Tool began serving the<br />

Orthopaedic Industry in 1988.<br />

BONEZone • Winter 2005 39


DY-FO<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

195 Museum Road<br />

Washington, PA 15301<br />

USA<br />

30262 Crown Valley Parkway<br />

Suite 273<br />

Laguna Niguel, CA 92677<br />

USA<br />

1325 East 152nd Street<br />

PO Box 12007<br />

Cleveland, OH 44112<br />

USA<br />

40 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

Dynamet, Inc. RM<br />

724-228-1000 (phone)<br />

800-237-9655 (toll free)<br />

724-229-4195 (fax)<br />

949-495-5666 (phone)<br />

800-628-3343 (toll free)<br />

949-495-4161 (fax)<br />

tzuccarini@cartech.com<br />

www.cartech.com/dynamet<br />

Edge International RM<br />

metals@edgeintl.com<br />

www.edgeintl.com<br />

Electrolizing Corporation of OHIO, <strong>The</strong> ST<br />

Elos Medical MM MN<br />

Backedalsvagen 5<br />

Timmersdala S-540 16<br />

Sweden<br />

Empirical Testing Corp. AT<br />

4628 Northpark Drive<br />

Colorado Springs, CO 80918<br />

USA<br />

101 Wood Avenue<br />

Iselin, NJ 08830<br />

USA<br />

+46-511-440600 (phone)<br />

+46-511-440690 (fax)<br />

719-264-9937 (phone)<br />

719-264-1926 (fax)<br />

info@elos.se<br />

www.elos.se<br />

dlissy@empiricaltesting.com<br />

www.empiricaltesting.com<br />

Engelhard Corporation ST<br />

732-205-5000 (phone) info@engelhard.com<br />

www.engelhard.com<br />

Ensinger, Inc. RM<br />

365 Meadowlands Boulevard<br />

Washington, PA 15301<br />

USA<br />

724-746-6050 (phone) falder6347@aol.com<br />

Everest Metal MM MN<br />

82 Route 59, Unit 264<br />

Monsey, NY 10901<br />

USA<br />

845-369-8906 (phone)<br />

845-369-8947 (fax)<br />

everestfinishing@aol.com<br />

www.orthosupplier.com/profiles/<br />

everest-metal2.htm<br />

Faith, Inc. MM MN SP<br />

2856 Directors Cove<br />

Memphis, TN 38131<br />

USA<br />

3735 West Belmont Avenue<br />

Chicago, IL 60618<br />

USA<br />

773-539-8501 (phone)<br />

773-539-8627 (fax)<br />

bboucher@forecreu.com<br />

www.forecreu.com<br />

216-451-8655 (phone)<br />

800-451-8655 (toll free)<br />

216-451-4729 (fax)<br />

901-377-5515 (phone)<br />

877-505-2221 (toll free)<br />

901-377-5532 (fax)<br />

Forecreu America, Inc. — Player MM MN RM<br />

Manufacturer of Heavy Wall Tubing or Cannulated Bars in Stainless<br />

Steel and Titanium. We manufacture through hot extrusion and<br />

drawing, long, precision ground, cannulated bars (8-12 foot). Our<br />

typical O.D. range is from 3/16” to 5/8” and I.D. from 0.031” to<br />

0.169”, in grades such as, but not limited to, Custom 455, 17-4 PH,<br />

316-LVM and Titanium. In most cases, we can be an alternative to<br />

gun-drilling. Call us for availability and feasibility. ISO 9001:2000.<br />

nnoble@normannoble.net<br />

www.electrohio.com<br />

Fort Wayne Metals, Inc. RM<br />

9609 Indianapolis Road<br />

Fort Wayne, IN 46809<br />

USA<br />

260-747-4154 (phone)<br />

260-747-0398 (fax)<br />

tgs@faithmphs.com<br />

www.orthosupplier.com/profiles/faith2.htm<br />

info@fwmetals.com<br />

www.fortwaynemetals.com


Established in 1948, Handy & Harman Specialty Tube Company is a specialized<br />

manufacturer of high quality, small diameter stainless, nickel alloy, titanium and<br />

alloy tubing for the orthopaedic marketplace.<br />

Medical Tubing<br />

Handy & Harman manufactures a broad<br />

line of products specifically designed for<br />

medical applications, including fracture<br />

fixation devices, prosthetic implants and<br />

surgical instruments.<br />

Handy & Harman tubing is a seamless<br />

and cold-worked product that displays a<br />

high level of consistency from piece to<br />

piece.<br />

Supplied with a concentric and close tolerance<br />

hole (yielding a smooth and clean<br />

surface with no steps on the I.D.), Handy<br />

& Harman tubing has proven itself to be<br />

a more practical and economical alternative<br />

to gun drilled bar stock.<br />

Handy & Harman’s manufacturing process<br />

produces tube in a wide variety of grades<br />

that offer designers, fabricators and manufacturers<br />

a close tolerance product with<br />

specific mechanical properties.<br />

Tube Fabrication<br />

Tubing for Medical Devices<br />

Handy & Harman’s MicroTube Fabricators division offers a one-stop service of<br />

converting raw materials to finished components. Handy & Harman has precision<br />

and high speed automatic equipment to cut, flare, reduce, expand, bulge,<br />

bead, dimple, lance, slot, flatten & pierce and bend tubing. Medical and surgical<br />

applications include laparoscopy, endoscopy and arthroscopy.<br />

Handy & Harman’s combination of modern automated equipment that is coupled<br />

with highly experienced engineering talent provides the market with a<br />

source for high speed and low cost production of precision fabricated tube<br />

parts.<br />

Player Profile<br />

Handy & Harman<br />

Tube Company, Inc.<br />

701 West Township Line Road<br />

Norristown, PA 19403<br />

USA<br />

610-539-3900 (phone)<br />

610-539-3250 (fax)<br />

Web site<br />

www.handytube.com<br />

Founded<br />

1948<br />

Contacts<br />

Brian Martin<br />

Marketing Manager<br />

bmartin@handytube.com<br />

Facility<br />

200,000 sq. ft.<br />

Staff<br />

150 employees<br />

Certification<br />

ISO 9001:2000<br />

BONEZone • Winter 2005 41


FP-GU<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

1071 Out Rigger Cove<br />

Painesville Township, OH 44077<br />

USA<br />

440-352-1345 (phone)<br />

440-352-1355 (fax)<br />

sjyopko@stratos.net<br />

www.friedrich-daniels.com<br />

42 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

FPD Company FO MM ST<br />

124 Hidden Valley Road<br />

McMurray, PA 16037<br />

USA<br />

Lieu-dit le boissouteyrand<br />

Mondragon 84430<br />

France<br />

724-941-5540 (phone)<br />

724-941-8322 (fax)<br />

+33-490409707 (phone)<br />

+33-490409702 (fax)<br />

jrs@fpdinc.com<br />

www.fpdinc.com<br />

Frederic Liegeois, Consultant YY<br />

Award-Winning Designer and Manufacturer of Custom Surgical<br />

Instruments. Head-quartered in Solingen, Germany, we have satisfied<br />

the needs of the orthopaedic community with custom instrumentation<br />

for over 53 years. Our latest developments include T-handle,<br />

ratcheting and soft grip handles as well as a parallel action<br />

modular spinal distractor. Satisfaction guaranteed. ISO 9001:2000<br />

certified as well as FDA-registered and approved.<br />

fr.liegeois@wanadoo.fr<br />

www.orthoworld.com/members/<br />

directories/services/profiles/<br />

liegeois_consulting.php<br />

Friedrich Daniels — Player DS MN ST<br />

FS Precision Tech CA<br />

3025 East Victoria Street<br />

Rancho Dominguez, CA 90221<br />

USA<br />

310-638-0595 (phone)<br />

310-631-2884 (fax)<br />

Gauthier Biomedical, Inc. — Player MN<br />

1235 North Dakota Drive, Ste. G<br />

Grafton, WI 53024<br />

USA<br />

262-546-0010 (phone)<br />

866-546-0010 (toll free)<br />

262-546-0011 (fax)<br />

info@gauthierbiomedical.com<br />

www.gauthierbiomedical.com<br />

614 State Route 247<br />

Russellville, AR 72802-8408<br />

USA<br />

Medical & Biotechnology Group<br />

2374 North Penn Road<br />

Hatfield, PA 19440<br />

USA<br />

Solutions for Instruments. Orthopaedic & Spinal Instrumentation.<br />

Gauthier Biomedical is the inventor and first company to market<br />

ultra-precise ratcheting screwdrivers, the only design that provides a<br />

smooth, accurate ratchet feel, strong torque capability and virtually<br />

no play between the instrument shaft and the handle. Silicone Grip<br />

Handles. Torque-Measuring & Torque-Limiting Instruments. Spinal<br />

Instrumentation. FDA-registered, ISO 13485:2003 Certified.<br />

479-968-5455 (phone)<br />

479-968-5460 (fax)<br />

215-996-4734 (phone)<br />

215-996-4747 (fax)<br />

mike.wyte@fs-precision.com<br />

www.fs-precision.com<br />

Global Medical Partners, LLC MR YY<br />

PO Box 24497<br />

Lexington, KY 40524-4497<br />

USA<br />

859-552-9860 (phone)<br />

859-273-6206 (fax)<br />

Grace Manufacturing, Inc. MN<br />

gSource, LLC MN<br />

19 Bland Street<br />

Emerson, NJ 07630<br />

USA<br />

201-599-2277 (phone)<br />

800-978-1119 (toll free)<br />

201-599-3306 (fax)<br />

rsawyer44@aol.com<br />

www.globalmedicalpartners.com<br />

information@gracemfg.com<br />

www.gracemfg.com<br />

Greene, Tweed & Co. RM<br />

34, Grand’Rue<br />

Ferney-Voltaire, Rhone-Alpes 01210<br />

France<br />

+33-0-450-429-211 (phone)<br />

+33-0-153-013-525 (fax)<br />

bchadwick@gtweed.com<br />

www.gtweed.com<br />

email@gsource.us<br />

www.gsource.us<br />

Guiden YY<br />

qwarnstrom@wanadoo.fr


Orthopaedic and Spinal Instrumentation<br />

Gauthier Biomedical is the inventor and first to market ultra-precise ratcheting screwdrivers. This<br />

exclusive feature has been influential in the industry.<br />

Ultra-Precise Ratcheting Screwdrivers. <strong>The</strong> only design available that provides a smooth accurate<br />

ratchet feel, strong torque capability and virtually no play between the instrument shaft and the<br />

handle.<br />

Silicone Grip Handles. All catalog torque wrenches, ratcheting drivers, and quick connects can be<br />

incorporated into any straight handle, T-handle, and palm style configurations. <strong>The</strong>se handles are<br />

available in any color and configuration to fit the customer’s instrumentation needs. Custom handle<br />

shapes are available.<br />

Torque-Measuring and Torque-Limiting Instruments. GBI offers a variety of instruments that limit<br />

the amount of torque applied in surgery, and instruments that read out the actual torque. <strong>The</strong>se<br />

instruments can be preset to user-defined values and customized to meet specific applications.<br />

Spinal Instrumentation. Gauthier Biomedical continues to provide innovative instrumentation to<br />

solve common problems in spinal surgery. Catalog items are available for a variety of spinal procedures<br />

and can be customized for any application.<br />

Engineering and Product Design—<br />

Whether improving an existing tool or developing a unique custom instrument, GBI’s expertise<br />

turns ideas into reality.<br />

• Design experience rooted in biomedical engineering and orthopaedics<br />

• Engineering services to complement prototyping and manufacturing operations<br />

• Ability to join customer projects at any stage of development<br />

• Emphasis on Design for Manufacturability<br />

• Latest in 3-D CAD software for accuracy/verification<br />

Contract Manufacturing Services—<br />

• Registered with FDA as a contract manufacturer (#2134947)<br />

• Just In Time deliveries on production orders<br />

• Turnkey instrumentation to medical device OEMs<br />

• Silicone molded handles, ratcheting screwdrivers, shaft quick connects, torque limiting and<br />

torque measuring instruments, rod cutters, rod benders, bone awls, bone probes, sounders,<br />

taps, etc.<br />

Gauthier Biomedical works with all grades of stainless steel, aluminum alloys, plastics, phenolic,<br />

and silicone and offers the following processes for production of instruments and components:<br />

milling, turning, EDM, grinding, gun drilling, heat treating, welding, brazing, polishing, blasting,<br />

anodizing, passivation, electropolishing, laser marking and assembly.<br />

Quality—<br />

Solutions for Instruments<br />

Going beyond the process of blindly “making components,” GBI verifies Fit, Form and Function<br />

prior to production so that products not only meet print requirements, they exceed them.<br />

• Qualified personnel perform in-process inspections<br />

• Certifications of Conformance accompany every shipment<br />

• Detailed manufacturing records retained for every instrument<br />

Player Profile<br />

Gauthier Biomedical, Inc.<br />

1235 North Dakota Drive, Suite G<br />

Grafton, WI 53024<br />

USA<br />

262-546-0010 (phone)<br />

866-546-0010 (toll-free)<br />

262-546-0011 (fax)<br />

info@gauthierbiomedical.com<br />

Web site<br />

www.gauthierbiomedical.com<br />

Contacts<br />

Michael Gauthier<br />

President<br />

michael@gauthierbiomedical.com<br />

Certification<br />

ISO 13485:2003<br />

BONEZone • Winter 2005 43


HA-IN<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

Division of Hammill Mfg. Co.<br />

360 Tomahawk Drive<br />

Maumee, OH 43537<br />

USA<br />

419-476-0789 (phone)<br />

419-476-7568 (fax)<br />

john.hammill@hammill-mfg.com<br />

www.hammill-mfg.com<br />

701 West Township Line Road<br />

Norristown, PA 19403<br />

USA<br />

610-539-3900 (phone)<br />

610-539-3250 (fax)<br />

bmartin@handytube.com<br />

www.handytube.com<br />

720 West Willard<br />

Muncie, IN 47302<br />

USA<br />

44 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

Hammill Medical — Player MM MN MT<br />

40 Norfolk Avenue<br />

South Easton, MA 02375-1913<br />

USA<br />

508-238-3351 (phone)<br />

508-238-3807 (fax)<br />

prandall@holmed.net<br />

www.holmed.net<br />

Precision Manufacturing of Medical Implants & Bone Screws. Knee<br />

femoral components, trauma hip systems, modular hip systems,<br />

spinal systems. CNC grinding, 5-axis machining centers, CNC turning<br />

and mill/turn centers, 6-axis Swiss style turning, robotic polishing,<br />

laser part identification, CNC thread milling, ultrasonic cleaning and<br />

passivation. ProEngineer 3-D solid modeling for design and for integrated<br />

part programming. FDA Reg. #1530390.<br />

Handy & Harman Specialty Tube Company — Player MN RM ST<br />

320 Premier Court<br />

Suite 205<br />

Franklin, TN 37067<br />

USA<br />

Handy & Harman is a world leader in the manufacture of tubing for<br />

the medical industry. We offer a wide range of specialized tubing in<br />

stainless steel and titanium for use in bone implants, orthodontic<br />

appliances, surgical tools and medical devices. Handy & Harman<br />

medical tubing has proven to be a more practical and affordable<br />

substitute for gun drilled bar stock used by the medical industry in<br />

the past. ISO 9001:2000 certified.<br />

Hiatt Metal Products MN MT SO YY<br />

765-284-8351 (phone)<br />

765-282-4825 (fax)<br />

Design, Prototype and Manufacture of Medical Devices and<br />

Implants. We are a contract manufacturer working “Engineer to<br />

Engineer” with over 40 years of experience in the medical field.<br />

Our engineers and prototype machinists work hand-in-hand with<br />

your lead engineers and surgeons each day to develop new products<br />

and services for the medical field. We are FDA registered, ISO<br />

9001:2000 certified and 13485 certified by TUV.<br />

615-771-4100 (phone)<br />

615-771-4100 (fax)<br />

cmaryan@hiattmetal.com<br />

www.hiattmetal.com<br />

Holmed Corporation — Player MM MN SP<br />

Horn USA, Inc. MT<br />

Hower Tool — Player MM MN MT<br />

6935 North State Road 1<br />

Ossian, IN 46777<br />

USA<br />

260-622-4150 (phone)<br />

260-622-4151 (fax)<br />

tgregory@howertool.com<br />

www.howertool.com<br />

2045 Wellwood Avenue<br />

Farmingdale, NY 11735<br />

USA<br />

631-420-7000 (phone)<br />

631-420-7007 (fax)<br />

sales@hurontool.com<br />

www.hurontool.com<br />

Precision Contract Manufacturer of Implants, Tooling and Medical<br />

Devices. Hower Tool is a Hi Tech facility that can provide innovative<br />

solutions to take your design to a finished, packaged reality. We<br />

offer services such as In House Prototyping, CNC Mill (up to 5 Axis),<br />

CNC Lathe (including Live Tooling/Y Axis), Swiss, Wire EDM, Laser<br />

Etch, Passivation, Polishing, Welding and Packaging. ISO 9001:2000<br />

certified and FDA registered.<br />

Huron Tool & Cutter Grinding Co., Inc. — Player MN<br />

Turning Concept Into Reality. Drills, taps, planers, reamers, burrs,<br />

rasps. Huron Tool has designed an innovative approach to qualify<br />

the consistent performance of your product. We eliminate all subjective<br />

testing of your product by utilizing our specially designed test<br />

stand. Ultimately, you can provide your surgeons with the comfort<br />

they need to know that your product will perform consistently each<br />

and every time. ISO 9001:2000 certified.<br />

ddrape@hornusa.com<br />

www.hornusa.com<br />

Incision Tech AT LP MM MN PA RM SP ST YY<br />

9 Technology Drive<br />

Staunton, VA 24401<br />

USA<br />

540-213-7809 (phone)<br />

800-213-7809 (toll free)<br />

540-248-4400 (fax)<br />

sales@incisiontech.com<br />

www.incisiontech.com


Turning Concept into Reality<br />

With Age Comes Experience — More than 45 years of dedicated experience<br />

in specialized cutting tools has given Huron Tool the advantage in the<br />

orthopaedic industry. Our expertise in prototype development, cutting edge<br />

technology and complete project management assures the most cost effective<br />

approach to your orthopaedic needs.<br />

Exclusive at Huron: Comparative Performance Testing (CPT) - Huron<br />

Tool has designed an innovative approach to qualify the consistent performance<br />

of your product. We will eliminate all subjective testing of your product by<br />

utilizing our specially designed test stand. Ultimately, you can provide your surgeons<br />

with the comfort they need that your product will perform consistently<br />

each and every time.<br />

Product Development • Quality Assurance • Purchasing<br />

Call Huron for further details<br />

Continuous Commitment to Quality — It the company’s policy to operate<br />

at the highest industry standards. We work closely with our customers and<br />

suppliers to continuously maintain shipment of zero defect products, while<br />

accommodating all delivery requirements.<br />

We have adopted a forward-looking view on future business decisions. Huron<br />

Tool’s certification to the ISO 9001:2000 Standard has merely established a<br />

strong foundation for our continual improvement initiatives.<br />

Player Profile<br />

Huron Tool & Cutter<br />

Grinding Co., Inc.<br />

2045 Wellwood Avenue<br />

Farmingdale, NY 11735<br />

USA<br />

631-420-7000 (phone)<br />

631-420-7007 (fax)<br />

sales@hurontool.com<br />

Web site<br />

www.hurontool.com<br />

Founded<br />

1956<br />

Contacts<br />

James A. Cosenza<br />

President<br />

Richard J. Cosenza<br />

Vice President<br />

Rick.Cosenza@Hurontool.com<br />

Facility<br />

20,000 sq. ft.<br />

Certification<br />

ISO 9001:2000<br />

Focus<br />

Orthopaedic cutting instruments<br />

News Update, 11/05<br />

Recent capacity additions in<br />

manpower and equipment have<br />

resulted in Reduced Lead Times!<br />

BONEZone • Winter 2005 45


IN-JA<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

5305 Gray Eagle Court<br />

Carmel, IN 46033<br />

USA<br />

46 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

Incumed, Inc. YY<br />

7429 ACC Boulevard, Suite 107<br />

Raleigh, NC 27617<br />

USA<br />

Indiana Implant Castings, Inc. CA<br />

103 Estus Drive<br />

Savannah, GA 31404<br />

USA<br />

919-957-8686 (phone) info@incu-med.com<br />

www.incu-med.com<br />

317-581-0561 (phone)<br />

317-705-0224 (fax)<br />

Innomed, Inc. MN<br />

912-236-0000 (phone)<br />

800-548-2362 (toll free)<br />

912-236-7766 (fax)<br />

indianaimplants@aol.com<br />

info@innomed.net<br />

www.innomed.net<br />

Innovation Factory, <strong>The</strong> YY<br />

2750 Premiere Parkway, #200<br />

Duluth, GA 30097<br />

USA<br />

De Brauwweg 17<br />

Schiedam, 3125 AE<br />

Netherlands<br />

678-812-1103 (phone)<br />

678-417-7325 (fax)<br />

+31-10-462-6899 (phone)<br />

+31-10-462-6088 (fax)<br />

rick@innofactory.com<br />

www.innofactory.com<br />

Instrumek MM MN PA SP ST<br />

InterMed Precision Ltd. MM MN<br />

IDA Business Park<br />

Gort, Galway<br />

Ireland<br />

+353-91-630043 (phone)<br />

+353-91-630050 (fax)<br />

f.keijzer@instrumek.com<br />

www.instrumek.com<br />

jfarragher@intermed.ie<br />

www.intermed.ie<br />

Invibio, Inc. RM<br />

Invibio, Inc.<br />

3A Caledon Court<br />

Greenville, SC 29615<br />

USA<br />

866-INVIBIO (phone)<br />

864-672-7325 (fax)<br />

In´Tech Medical MN<br />

158 rue de l’église<br />

62180 RANG DU FLIERS<br />

France<br />

200 Roundhill Drive<br />

Rockaway, NJ 07866<br />

USA<br />

973-586-4720 (phone)<br />

973-586-4729 (fax)<br />

gene.elwood@ionbond.com<br />

www.ionbond.com<br />

+33-(0)-3-21-89-60-00 (phone)<br />

+33-(0)-3-21-89-60-09 (fax)<br />

Highest Quality Thin-film Coatings. Specialists in Surface<br />

Engineering, Bernex (CVD) & Multi-Arc (PVD). Pioneers in thin-film<br />

technologies. Our product portfolio comprises an unmatched range<br />

of coatings systems and services for a vast number of applications,<br />

and is marketed worldwide under the brand name Ionbond. <strong>The</strong><br />

Medthin Global Medical Division has been established to provide<br />

biocompatible products, services and consultation services.<br />

info@invibio.com<br />

www.invibio.com<br />

lpruvost@intech-medical.com<br />

www.intech-medical.com<br />

IonBond — Medithin — Player AT SP ST YY<br />

Japan Medical Materials Corporation MM RM ST<br />

Uemura Niessei Bldg., 3-3-31 Miyahara<br />

Yodogawa-ku,<br />

Osaka, Osaka 532-0003<br />

Japan<br />

06-6350-1093 (phone)<br />

06-6350-5752 (fax)<br />

nishidam@jmmc.jp<br />

www.jmmc.jp<br />

Jarvis Surgical, Inc. / Jarvis Precision Polishing MM SP<br />

53 Airport Road<br />

Westfield, MA 01085<br />

USA<br />

860-342-5000 (phone)<br />

860-342-5006 (fax)<br />

bredm@jarvisairfoil.com<br />

www.orthosupplier.com/profiles/<br />

jarvis-surgical2.htm


Instrument Cases & Trays<br />

Metal Cases and Trays<br />

No company offers a wider selection of case designs in<br />

metal than Jewel Precision. No matter if you require a<br />

new look or help with your current production, our<br />

engineering staff can assist you. Every new delivery system<br />

provides us with an opportunity to be innovative.<br />

Distinctive features of our systems include our patented<br />

latch design, rigid silicone brackets, 3-dimensional<br />

graphics and color coding silk-screening and anodize.<br />

Machined Propylux and Aluminum Modules<br />

When holding very small implants or screws these<br />

trays can be machined to very tight tolerances to<br />

keep parts from shaking loose. <strong>The</strong>se trays can be<br />

designed to be used as stand alone sterilization<br />

trays or integrated into our other style trays.<br />

Advantages of our machined modules include laser<br />

graphics or silk-screen graphics of the instrumentation,<br />

light weight construction and extremely<br />

tight tolerance to keep parts in place.<br />

PlasTel<br />

PlasTel is a patented hybrid material in which we<br />

coat a light weight aluminum tray or case with a<br />

very durable plastic polymer. This process yields a<br />

tray that looks and feels like plastic but eliminates<br />

the negative drawbacks of a plastic tray.<br />

Advantages of a Plastel tray vs. a plastic tray are<br />

improved holding of the instruments, full scale<br />

graphics of the instruments to aid in repacking the<br />

trays after use, elimination of wet packing and<br />

improved sterilization validation times.<br />

PlasTel looks like plastic, acts like metal.<br />

Plastic Trays<br />

We offer a wide variety of outstanding designs in a wide variety<br />

of different size trays. We use Radel 5500R exclusively in<br />

our manufacturing process. Advantages of our plastic trays<br />

include a wide variety of colors available in inventory, silkscreen<br />

or laser graphics and rapid prototyping.<br />

SurgiNizer Modular Instrument<br />

Organizing System Sterilization Case<br />

This generic instrument organizing system is ideal for workshops,<br />

clinical and other uses when a case or tray is needed<br />

in a rush. <strong>The</strong> user has a catalogue of different size trays,<br />

cases and instrument holding brackets to design their own<br />

tray. <strong>The</strong>se trays and cases can be used independently or<br />

mated together to form larger systems. No tools are required<br />

to assemble any of the components. Visit our on-line catalogue<br />

at www.jewelprecision.com and click on SurgiNizer.<br />

Player Profile<br />

Jewel Precision<br />

200 Commerce Road<br />

Cedar Grove, NJ 07009<br />

USA<br />

973-857-5545 (phone)<br />

973-857-5548 (fax)<br />

info@jewelprecision.com<br />

Web site<br />

www.jewelprecision.com<br />

Founded<br />

1984<br />

Contacts<br />

Jerry Grieco<br />

Vice President<br />

jerry@jewelprecision.com<br />

Facility<br />

52,000 sq. ft.<br />

Certification<br />

FDA Registered<br />

ISO 9001:2000<br />

Background<br />

Innovative designs, superior quality and<br />

deliveries our customers can rely on<br />

have propelled Jewel Precision to a<br />

leadership position in the design and<br />

manufacturing of sterilization case<br />

delivery systems. Jewel Precision offers<br />

one of the most diverse lines of sterilization<br />

case product lines available.<br />

Innovative sterilization case designs are<br />

available in aluminum or stainless<br />

steel, thermoformed plastic (Radel),<br />

machined modules in plastic or aluminum<br />

and our patented material<br />

PlasTel. All aspects of the manufacturing<br />

process are carefully controlled<br />

in-house. Controlling all the design and<br />

manufacturing functions in-house<br />

allows us to offer some of the fastest<br />

lead times in the industry. We can provide<br />

our clients with sterilization delivery<br />

systems from concept to conclusion.<br />

Our SurgiNizer Modular<br />

Instrument Organizing System allows<br />

the user to order a wide variety of different<br />

size trays, cases and instrument<br />

holding brackets from our on-line catalogue<br />

to build their own sterilization<br />

delivery system. No tools required! This<br />

system is ideal for clinical trials or<br />

workshops where the user needs sterilization<br />

cases and trays and does not<br />

have the opportunity to wait for a<br />

custom system.<br />

BONEZone • Winter 2005 47


JE-KO<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

200 Commerce Road<br />

Cedar Grove, NJ 07009<br />

USA<br />

973-857-5545 (phone)<br />

973-857-5548 (fax)<br />

info@jewelprecision.com<br />

www.jewelprecision.com<br />

1401 King Road<br />

West Chester, PA 19380<br />

USA<br />

610-648-8000 (phone)<br />

800-442-1405 (toll free)<br />

610-648-8111 (fax)<br />

metalinfo@jmusa.com<br />

www.jmmedical.com<br />

48 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

Jewel Precision — Player DS<br />

40 Rockdale Street<br />

Worcester, MA 01606<br />

USA<br />

Sterilization Cases & Trays in Metal, Plastic or PlasTel. Our<br />

Proprietary Hybrid. Machined caddies in aluminum, plastic or hybrid.<br />

Our SurgiNizer Modular Surgical Instrument Organizing System<br />

offers a catalogue solution to instrument organization. All manufacturing<br />

performed in one facility, under one roof, allowing us to offer<br />

the widest product array, shortest lead times and greatest economy<br />

of scale with no outsourcing delay. FDA Registered, ISO 9001:2000<br />

certified.<br />

Johnson Matthey Inc. — Player LP MM MN MT ST<br />

147 Bell Street<br />

Suite 303<br />

Chagrin Falls, OH 44022<br />

USA<br />

Machines, draws, rolls and forms Nitinol (superelastic & shape<br />

memory alloys), PGM & Specialty Metals for the manufacture of<br />

orthopaedic component parts, instruments & tooling. Features<br />

include rapid prototyping, engineering & product development support,<br />

& high-volume manufacturing. Full SPC systems and customized<br />

documentation ensure process control, consistency and<br />

product repeatability. ISO 9001:2000 certification.<br />

Kays Engineering, Inc. MM MN MT<br />

900 Industrial Drive<br />

Marshall, MO 65340<br />

USA<br />

Keller Engineering, Inc. CP LP MM PA<br />

3203 Kashiwa Street<br />

Torrance, CA 90505<br />

USA<br />

310-326-6291 (phone)<br />

310-326-0417 (fax)<br />

Design, development, manufacture and packaging of orthopaedic<br />

and spinal surgical instruments. As a certified vendor to many of<br />

the world’s most respected orthopaedic and spinal companies,<br />

KMedic offers customers a one-stop source for instruments.<br />

Through KMedic’s Total Instrument Management program, customers<br />

find a partner who consistently demonstrates the ability to<br />

design, develop, manufacture and package a wide array of custom<br />

and standard instrumentation. FDA-registered, Certified to ISO<br />

13485:2003.<br />

Knowledge Enterprises, Inc. YY<br />

440-247-9051 (phone)<br />

440-247-9053 (fax)<br />

KomteK Technologies CA FO MM MN<br />

508-853-4500 (phone)<br />

508-853-2753 (fax)<br />

steve@kellereng.com<br />

www.kellereng.com<br />

Kensey Nash Corporation MM RM<br />

55 East Uwchlan Avenue<br />

Exton, PA 19341<br />

USA<br />

610-524-0188 (phone)<br />

610-524-0265 (fax)<br />

info@kenseynash.com<br />

www.kenseynash.com<br />

Kinamed, Inc. MM PA<br />

820 Flynn Road<br />

Camarillo, CA 93012-8701<br />

USA<br />

KMedic — Player MN<br />

A Teleflex Medical Company<br />

190 Veterans Drive<br />

Northvale, NJ 07647<br />

USA<br />

201-767-4002 (phone)<br />

800-955-0559 (toll free)<br />

201-768-0494 (fax)<br />

oeminfo@kmedic.com<br />

www.kmedicoem.com<br />

660-886-9929 (phone)<br />

660-886-2249 (fax)<br />

805-384-2748 (phone)<br />

800-827-5775 (toll free)<br />

805-384-2792 (fax)<br />

ekays@kays-dehoff.com<br />

www.kays-dehoff.com<br />

contact@kinamed.com<br />

www.kinamed.com<br />

knowledge@orthoworld.com<br />

www.theorthopeople.com<br />

kervickr@komtektech.com<br />

www.komtektech.com


Orthopedic Surgical Instruments<br />

KMedic, a leading supplier of orthopedic surgical instruments,<br />

is a certified vendor to many of the world’s most respected<br />

orthopedic and spinal companies.<br />

Through the KMedic Total Instrument Management (TIM) program, customers find a partner<br />

who consistently demonstrates the ability to design, develop, manufacture and<br />

package a wide array of custom and standard instrumentation.<br />

KMedic offers companies supply chain management for orthopedic surgical instruments.<br />

In most of our relationships, we serve as a long-term, strategic partner—developing<br />

entire instrument lines and custom instrumentation. We are the resource of choice for<br />

specific instrumentation—providing highly crafted instruments in small and large quantities.<br />

Our customers value our commitment to providing a total solution for their instrument<br />

needs.<br />

Design, Development and Manufacturing Capabilities<br />

• Design Software: Solid Works and Auto-CAD<br />

• Processes: passivation, thermal assembly, certified special<br />

stainless steel TiN and TiAlN coating process<br />

• Domestic and International Manufacturing: multi axis CNC<br />

machining and turning centers, swiss type multi axis CNC<br />

turning centers, CNC grinding, CNC robotics, wire and ram<br />

EDM equipment, laser marking, electro chemical etching,<br />

tool room, welding, soldering, brazing, stamping, bending,<br />

honing and broaching<br />

Services<br />

• Engineers on staff work with your design surgeons to minimize time to market, from<br />

the design phase to prototyping and through delivery<br />

• Instrument design expertise<br />

• Forging design and management<br />

• First Article Sample (FAS) work<br />

• Quality Assurance inspection and certification<br />

• Full product packaging and labeling<br />

• Inventory management<br />

• EDI service<br />

• Quick response from our customer service, product development, QA and packaging<br />

engineering staff<br />

• Video conferencing for better communications<br />

• KMedic Europe, headquartered in Tuttlingen, Germany, manages international manufac<br />

turing and customer support<br />

Products<br />

KMedic Sourcebooks offer more than 3,300 readily available patterns for orthopedic,<br />

spinal, foot and ankle and hand procedures. Whether your company requires modifications<br />

of existing designs or crafting of entirely new instruments, we invite you to call<br />

and discuss how KMedic can provide the instruments you require.<br />

Player Profile<br />

KMedic<br />

A Teleflex Medical Company<br />

190 Veterans Drive<br />

Northvale, NJ 07647<br />

USA<br />

262-657-2800 (phone)<br />

800-295-8505 (toll-free)<br />

262-657-2801 (fax)<br />

Web site<br />

www.teleflexmedicaloem.com<br />

Sales Contacts<br />

Douglas Slomski<br />

Sales Director<br />

Teleflex Medical OEM Orthopedics<br />

dslomski@teleflexmedical.com<br />

Central US<br />

Greg Kitchens<br />

OEM Sales Manager<br />

gkitchens@kmedic.com<br />

West Coast<br />

Steve Pubols<br />

OEM Sales Manager<br />

spubols@kmedic.com<br />

Europe<br />

Armin Grab<br />

Product Manager<br />

armin.grab@teleflexmedical.com<br />

Founded<br />

1986<br />

Certification<br />

FDA-registered<br />

Certified to ISO 13485: 2003<br />

Focus<br />

Orthopedic, trauma, reconstructive,<br />

arthroscopic and spinal surgical<br />

instruments<br />

Background<br />

Founded in 1986, KMedic is a leading<br />

provider of Orthopedic surgical instruments.<br />

In 1999, KMedic became part of Teleflex<br />

Medical, a division of Teleflex Incorporated<br />

(NYSE: TFX), a worldwide leader in the<br />

design, manufacturing and distribution of<br />

high-quality engineered surgical instruments,<br />

medical devices and healthcare<br />

supplies.<br />

In 2003, KMedic and Beere joined together<br />

as Teleflex Medical OEM Orthopedics to<br />

provide a single source for customers’<br />

instrument needs.<br />

In 2005, KMedic and Beere US are<br />

located together in the same facility<br />

in Kenosha, WI.<br />

BONEZone • Winter 2005 49


KX-MA<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

50 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

Kx Simulation Technologies, Inc. AT SO YY<br />

441 Vine Street<br />

Carew Tower, Suite 4200<br />

Cincinnati, OH 45202<br />

USA<br />

Laser Graphx, Inc. LP<br />

7196 North State Road 13<br />

North Webster, IN 46555<br />

USA<br />

Leis Partners, LLC — Player AT DS MM MN RM<br />

700 Park Avenue, Suite F<br />

Winona Lake, IN 46590<br />

USA<br />

574-372-3348 (phone)<br />

574-372-3349 (fax)<br />

robdelp@leispartners.com<br />

www.leispartners.com<br />

Comprehensive Medical Technologies. <strong>The</strong> ultimate goal of Leis<br />

Partners is to produce complete orthopaedic sets: technologies &<br />

services that change the way suppliers do business in the future.<br />

We’re more than an instrument and case/tray job shop trying to fill<br />

instrument sets. We’re raising the bar for suppliers and innovating<br />

the supply chain by resourcefully and completely solving issues on<br />

both the implant and the instrument sides.<br />

L H Industries AT MM MT SO YY<br />

4420 Clubview Drive<br />

Fort Wayne, IN 46804<br />

USA<br />

Lighthouse Industries CP MN MT YY<br />

P.O. Box 8905<br />

107 Eastwood Road<br />

Michigan City, IN 46360<br />

USA<br />

M-PACT Worldwide, L.L.C. — Player RM<br />

1040 OCL Parkway<br />

Eudora, KS 66025<br />

USA<br />

785-542-2920 ext. 109 (phone)<br />

800-255-4152 ext. 109 (toll free)<br />

785-542-3608 (fax)<br />

msloan@mpactllc.com<br />

www.oemfracturemanagement.com<br />

13800 Luick Drive<br />

Chelsea, MI 48118-9588<br />

USA<br />

734-475-9165 (phone)<br />

734-475-3825 (fax)<br />

info@macdeeinc.com<br />

www.macdeeinc.com<br />

513-929-9301 (phone)<br />

513-929-4630 (fax)<br />

574-834-7100 (phone)<br />

574-834-4443 (fax)<br />

ONE SOURCE for Manufacturing of Fracture Management Products.<br />

For over 23 years, M-PACT has been a proven supplier of innovative,<br />

high quality, cost-effective medical products with over ten<br />

patents. Our core technologies: Plaster of Paris Creation and<br />

Conversion, Synthetic Casting Tapes, Synthetic Splinting Rolls and<br />

Electro Mechanical, along with our packaging and distribution<br />

options, provide SOLUTIONS for our customers’ needs. FDA-registered,<br />

ISO 9001:2000, EN ISO 13485, CE Mark.<br />

MACDEE, Inc. — Player MM MN PA<br />

Contract Manufacturer for the Orthopaedic Industry. Specializing in<br />

plastic machining, injection molding and sterile packaging, MACDEE<br />

has earned the reputation as a trusted source for high quality products.<br />

Our vast experience in processing a wide variety of polymers<br />

allows us to consistently exceed customer expectations regarding<br />

tolerances and critical surface finishes. FDA-registered, ISO certified.<br />

Machining Technology Group MM MN<br />

11450 Gulf Stream Avenue<br />

Arlington, TN 38002<br />

USA<br />

260-432-5563 (phone)<br />

260-432-2503 (fax)<br />

219-879-1550 (phone)<br />

219-879-1509 (fax)<br />

901-867-2030 (phone)<br />

901-867-2035 (fax)<br />

brad.stevens@kxinc.com<br />

www.kxinc.com<br />

bhack@ligtel.com<br />

www.orthosupplier.com/profiles/<br />

laser-graphx2.htm<br />

bemerick@lhindustries.com<br />

www.lhcarbide.com<br />

tthomas@lighthouseindustries.com<br />

www.lighthouseindustries.com<br />

thanson@mtgemail.com<br />

www.mtgmemphis.com<br />

Macromedical Development LLC YY<br />

800 Village Square Crossing<br />

Suite 104<br />

Palm Beach Gardens, FL 33410<br />

USA<br />

561-694-5711 (phone)<br />

561-694-5811 (fax)<br />

lc@macromedicaldevelopment.com<br />

www.macromedicaldevelopment.com


OEM Casting & Splinting Products<br />

ONE SOURCE<br />

for Original Equipment Manufacturing<br />

of Fracture Management Products<br />

M-PACT was formed when Orthopaedic Casting Laboratory, inventors of the<br />

patented OCL® Splint Roll Custom Splinting System and Martin Medical, inventors<br />

of the American Orthopaedic and TurboCare® Cast Removal Systems<br />

merged.<br />

For over 25 years, M-PACT has been a proven supplier of innovative, high quality,<br />

cost-effective medical products. Our portfolio of more than ten patents<br />

highlights our commitment to research and development. Worldwide, we have<br />

earned the reputation for providing quality casting and splinting products, cast<br />

removal products and cast room products.<br />

• Synthetic Casting Tape<br />

• Splinting Rolls<br />

• Cast Removal<br />

• Plaster of Paris<br />

Outsourcing—once viewed only as a strategic lever for keeping costs down for<br />

companies—is today a vital management tool for business innovation, company<br />

expansion, and competitive advantage. We understand the issues you<br />

face every day. We can help your company enhance your current product line<br />

to achieve an increase in net profits.<br />

Our experience provides customers with options and solutions in product<br />

development, packaging, and distribution. When tailoring a solution to meet<br />

specific needs, we give you choices to help you achieve your objectives.<br />

Player Profile<br />

M-PACT Worldwide, L.L.C.<br />

1040 OCL Parkway<br />

Eudora, KS 66025<br />

USA<br />

785-542-2920 (phone)<br />

800-255-4152 (toll-free)<br />

785-542-3608 (fax)<br />

Web site<br />

www.oemfracturemanagement.com<br />

Founded<br />

1980<br />

Contacts<br />

Holly Hayes<br />

OEM Sales and Product<br />

Coordinator<br />

hhayes@mpactllc.com<br />

Barry Price<br />

Chief Operating Officer<br />

bprice@mpactllc.com<br />

Facility<br />

42,000 sq. ft.<br />

Staff<br />

100 employees<br />

Certification<br />

FDA-registered<br />

ISO 9001:2000<br />

EN ISO 13485<br />

CE Mark<br />

BONEZone • Winter 2005 51


MA<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

Mahar Medical<br />

120 East Center Street<br />

Warsaw, IN 46580<br />

USA<br />

574-527-5889 (phone)<br />

800-497-4449 (toll free)<br />

765-254-9658 (fax)<br />

mkovaleski@mahartool.com<br />

www.mahartool.com<br />

Medizintechnik GmbH<br />

Friedrich-Wohler-Str. 10<br />

Emmingen-Liptingen, B-W 78576<br />

Germany<br />

7465-927526 (phone)<br />

7465-927529 (fax)<br />

ralf.rotter@mahe-med.de<br />

www.mahe-ortho.de<br />

7680 Innovation Way<br />

Mason, OH 45040<br />

USA<br />

52 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

Mahar Tool Supply — Player MT YY<br />

4520 Burnett Drive<br />

South Bend, IN 46614<br />

USA<br />

Distribution & Commodity Management in Cutting Tools & More!<br />

Specializing in metal-removal & distribution since 1947. Offering<br />

products, services & consultation to meet your tooling & inventory<br />

management needs. We take pride in offering custom solutions that<br />

generate bottom-line savings. Bringing you the latest technology<br />

and helping you manage it to achieve excellence! Call us today to<br />

schedule a demonstration! ISO 9001 :2000 Certified.<br />

MAHE - Barthelmes Medizintechnik GmbH — Player MM MN<br />

P.O. Box 218<br />

Zionsville, IN 46077<br />

USA<br />

Precision Tools for the Orthopaedic Field. Since 1990, we manufacture<br />

OEM Orthopaedics/Traumatology and Spinal instruments and<br />

implants. State of the art CNC milling, turning and grinding<br />

machines. Your one-stop source, from product development to final<br />

inspection. High quality and shortest turn around times are guaranteed.<br />

Certified to ISO 13485:2003 and ISO 9001:2000.<br />

Makino MT<br />

Mar-Test, Inc. AT<br />

1245 Hillsmith Drive<br />

Cincinnati, OH 45215<br />

USA<br />

513-573-7200 (phone)<br />

800-552-3288 (toll free)<br />

513-573-7360 (fax)<br />

513-771-2536 (phone)<br />

513-771-2564 (fax)<br />

Mark Machine, Inc. — Player MM MN<br />

50 Dwight Place<br />

Fairfield, NJ 07004-3312<br />

USA<br />

973-227-6400 (phone)<br />

973-227-7257 (fax)<br />

info@markmachine.com<br />

www.markmachine.com<br />

Design & Manufacture of Orthopaedic Devices. Over the past 20<br />

years, Mark Machine has made precision and quality an everyday<br />

habit. We house an up to 5-axis CNC Milling department and a CNC<br />

Turning department and an unequaled Swiss Style Turning/Screw<br />

Machine department capable of producing bone screws, implants,<br />

all types of screws of varying complexity and any high precision<br />

miniature component. FDA-registered. ISO 9001:2000 certified.<br />

Marox Corporation — Player CP MM MN<br />

373 Whitney Avenue<br />

Holyoke, MA 01040<br />

USA<br />

413-536-1300 (phone)<br />

413-534-1829 (fax)<br />

marox@marox.com<br />

www.marox.com<br />

Manufacturer of Implants, Instruments, Cutting Tools, Devices.<br />

Precision machining and assembly of orthopaedic, spinal and<br />

trauma components. Specialties include CNC milling (up to 5-axis),<br />

CNC turning, CNC Swiss screw machining (up to 12-axis), CNC wire<br />

EDM and assemblies. Services include: prototypes, product launching,<br />

production, project management and vendor managed inventory.<br />

FDA-registered. ISO 9001:2000 and ISO 13485 certified.<br />

574-299-0222 (phone)<br />

574-299-1187 (fax)<br />

Matco, Inc. CA DS MM MN MR<br />

mark.rentschler@makino.com<br />

www.makino.com<br />

BNeugebauer@mar-test.com<br />

www.mar-test.com<br />

Master Metal Engineering, Inc. CP MM MN SP<br />

sales@mastermetal.net<br />

www.mastermetal.net<br />

317-873-5730 (phone) brianhusselman@matco-inc.com


Spinal Components, Orthopaedic Implants & Instruments<br />

Precision CNC Machining — Marox provides precision CNC machining and<br />

assembly services for the spine, joint replacement, hand and extremity and<br />

fracture management markets. Specific products include bone plates and<br />

screws, spinal implants, hip/knee implants, hand implants and surgical instruments.<br />

Quality — Our Quality System is ISO 9001:2000, ISO 13485 and FDA-registered.<br />

Much of our work is performed within the Lean Manufacturing concept which<br />

emphasizes efficient product flow and continuous process improvement. Some<br />

of our customers have granted Marox “Dock-to-Stock” status and recognized us<br />

as “<strong>Supplier</strong> of the Year” to reflect our successes in producing high quality<br />

products and achieving total customer satisfaction.<br />

People — <strong>The</strong> Marox team includes specialists in engineering, manufacturing,<br />

quality control, and project support. We have attracted some of the foremost<br />

machining and business professionals. Our commitment to provide resources<br />

for the ongoing training and advancement of our workforce is reflected in the<br />

dedication of our people to their company, their customers, and one another.<br />

Our manufacturing capabilities include:<br />

• CNC Milling (4&5 Axis)<br />

• CNC Swiss Screw Machining (12-Axis)<br />

• Double Spindle CNC Turning Centers<br />

• CNC Wire EDM<br />

• Product Development and Launching<br />

• Prototypes<br />

• Production<br />

• Assemblies<br />

• Project Management<br />

Our engineering, business, quality, and production systems are fully integrated,<br />

and we continually upgrade and expand to ensure customers get what they<br />

want.<br />

Player Profile<br />

MAROX Corporation<br />

373 Whitney Avenue<br />

Holyoke, MA 01040<br />

USA<br />

413-536-1300 (phone)<br />

413-534-1829 (fax)<br />

marox@marox.com<br />

Web site<br />

www.marox.com<br />

Founded<br />

1951<br />

Contacts<br />

Brad Rosenkranz<br />

Vice President - Sales/Marketing<br />

brad@marox.com<br />

413-536-1300 X112<br />

Facility<br />

48,000 sq. ft.<br />

Staff<br />

70 employees<br />

Certification<br />

FDA-registered<br />

ISO 9001:2000<br />

ISO 13485<br />

Focus<br />

Precision Machining and<br />

Assemblies of Spinal/Orthopaedic<br />

Implants and Instruments<br />

BONEZone • Winter 2005 53


MC-ME<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

292 East Lafayette Frontage Road<br />

St. Paul, MN 55107<br />

USA<br />

54 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

McKenna Group CA MM MN MT PA ST<br />

Lawn Road Industrial Estate<br />

Lawn Road<br />

Carlton-in-Lindrick, Worksop<br />

S81 9LB<br />

UK<br />

McLean Medical and Scientific, Inc. MN<br />

Medical Device Testing & Innovations, LLC AT<br />

1469 Tallevast Road<br />

Sarasota, FL 34243<br />

USA<br />

+44-(0)-1909-541-414 (phone)<br />

+44-(0)-1909-541-415 (fax)<br />

651-227-9953 (phone)<br />

800-777-9987 (toll free)<br />

651-227-7859 (fax)<br />

908-227-0210 (phone)<br />

941-360-1966 (fax)<br />

sales@mckennagroup.co.uk<br />

www.mckennagroup.co.uk<br />

scanlanjoe@surgicaltechnologies.com<br />

www.mcleanmedical.com<br />

steveli@prodigy.net<br />

MedicineLodge, Inc. MM MN SP YY<br />

180 South 600 West<br />

Logan, UT 84321<br />

USA<br />

435-753-7675 (phone)<br />

435-753-7698 (fax)<br />

Medin Corporation DS<br />

90 Dayton Avenue, Building 16C<br />

Passaic, NJ 07055<br />

USA<br />

2710 American Way<br />

Fort Wayne, IN 46809<br />

USA<br />

260-479-4100 (phone)<br />

877-4POLYHI (toll free)<br />

260-478-1074 (fax)<br />

mark.evans@qplas.com<br />

www.meditechpolymers.com<br />

contact@medicine-lodge.com<br />

www.medicine-lodge.com<br />

Medtech Group, Inc., <strong>The</strong> CP MM MN PA<br />

6 Century Road<br />

South Plainfield, NJ 07080-1396<br />

USA<br />

3 Berkshire Boulevard<br />

Bethel, CT 06801<br />

USA<br />

Merete Medical GmbH Berlin MM MN<br />

Alt Lankwitz 102<br />

D-12247 Berlin<br />

Germany<br />

12797 Meadowvale Road<br />

Elk River, MN 55330<br />

USA<br />

973-779-2400 (phone)<br />

800-922-0476 (toll free)<br />

973-779-2463 (fax)<br />

MediTECH — Player RM<br />

Polymer-based Solutions for Industry. Supplying leading orthopaedic<br />

implant manufacturers worldwide for more than 30 years, Poly Hi<br />

Solidur’s MediTECH® has become the world leader in ram-extrusion<br />

and compression-molding of premium grade UHMWPE as specified<br />

by orthopaedic implant manufacturers for use as implant bearing<br />

surfaces. (Extrulen and Chirulen are the preferred articulating surfaces<br />

for joint replacements.) Certifications: DIN EN ISO 9001:2000,<br />

DIN EN ISO 14001:1996.<br />

908-561-0717 (phone)<br />

908-561-7314 (fax)<br />

Memry Corporation CP MM MN RM<br />

203-739-1100 (phone) info@memry.com<br />

www.memry.com<br />

+49-(0)-30-77-99-80-0 (phone)<br />

+49-(0)-30-6-68-03-61 (fax)<br />

Metal Craft Machine & Engineering, Inc. MM MN<br />

763-441-1855 (phone)<br />

763-441-0798 (fax)<br />

info@medin.com<br />

www.medin.com<br />

harrietb@medtech-grp.com<br />

www.medtech-grp.com<br />

service@merete.de<br />

www.merete.de<br />

djehlers@metal-craft.com<br />

www.metal-craft.com


Specializing in Metal Removal Products<br />

Mahar Tool Supply is a reputable distributor specializing in metal removal<br />

products since 1947. Our staff is comprised of specialists with years of knowledge<br />

and experience in inventory management, cutting tool technology,<br />

process improvement, manufacturing and machining. We represent all major<br />

manufacturers and we are a non-biased supplier. Most importantly, we provide<br />

value-added services to help you attain EXCELLENCE!<br />

Our core product capabilities include,<br />

but are not limited to:<br />

• standard / special perishable tooling<br />

• standard / special durable tooling<br />

• standard / special machine parts<br />

• gage re-calibration / maintenance<br />

• abrasives<br />

• MRO<br />

• fixturing / part-touching details<br />

• regrind / warrenty repairs<br />

• coating services<br />

• coolants<br />

• tapes and adhesives<br />

• air and electric tools<br />

Some of the benefits availabe by partnering<br />

with MAHAR TOOL SUPPLY include:<br />

• one-stop, turn-key solution<br />

• total inventory management<br />

• techinical and educational seminars<br />

• data management<br />

- (i.e. usage reports, CPU tracking)<br />

• focused on cost analysis and reduction<br />

• on-site tool testing<br />

• bar-coding and vending<br />

• one monthly invoice - less paperwork<br />

• 24 hour emergency service<br />

• dedicated personnel<br />

• EDI capable<br />

• experience in the medical industry<br />

When it comes to manufacturing, you want to partner with experience.<br />

Choose MAHAR TOOL SUPPLY as your partner.<br />

Player Profile<br />

MAHAR TOOL SUPPLY<br />

COMPANY, INC.<br />

Headquarters in<br />

Saginaw, Michigan USA<br />

MAHAR MEDICAL<br />

120 East Center St.<br />

Warsaw, IN 46580<br />

(574) 527-7889<br />

(800) 497-4449<br />

Web site<br />

www.mahartool.com<br />

Facility<br />

6 branches, 5 stocking locations<br />

Founded<br />

1947<br />

Contact<br />

Mike Kovaleski<br />

President<br />

mikekov@mahartool.com<br />

Staff<br />

135 people strong<br />

Registration/Certification<br />

ISO 9001:2000 Certified<br />

BONEZone • Winter 2005 55


MI-M0<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

5805 Keystone Street<br />

Philadelphia, PA 19135<br />

USA<br />

215-744-0770 (phone)<br />

215-744-3787 (fax)<br />

microcision@microcision.com<br />

www.microcision.com<br />

225 Smith Drive<br />

Clayton, OH 45315<br />

USA<br />

56 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

Microcision, Inc. — Player CP MM MN<br />

2032 Lagoon Drive<br />

Okemos, MI 48864-2749<br />

USA<br />

9470 Pinecone Drive<br />

Mentor, OH 44060<br />

USA<br />

440-354-9595 (phone)<br />

440-354-8989 (fax)<br />

sales@miltronics-skye.com<br />

www.miltronics-skye.com<br />

Precision Miniature Components & Assemblies. Consistent, Accurate,<br />

On Time, On Budget. Microcision is a custom manufacturer of precision<br />

machined miniature components and assemblies with tolerances<br />

as tight as .0001”. From prototypes to production,<br />

Microcision’s capabilities include complex drilling, cross-drilling,<br />

threading and milling of small parts made of exotic, precious and<br />

base metals as well as machinable plastics.<br />

Microfinish, Inc. LP SP<br />

5865 East State Road 14<br />

Columbia City, IN 46725<br />

USA<br />

1565 North Main Street<br />

Suite 502<br />

Fall River, MA 02720<br />

USA<br />

937-836-6622 (phone)<br />

937-832-2359 (fax)<br />

260-625-3304 (phone)<br />

260-625-3834 (fax)<br />

Mike Garrette Agency, Inc. CA FO MM MR<br />

517-349-9131 (phone)<br />

509-471-1609 (fax)<br />

508-679-8384 (phone)<br />

508-679-8414 (fax)<br />

Miltronics & Skye — Player MM MN<br />

Engineering Parts — Perfect Performance. When your reputation and<br />

other peoples’ lives are dependent on the quality of the products<br />

you produce, Miltronics & Skye is the preferred supplier for small,<br />

highly engineered, complexly-designed parts. We apply Six Sigma<br />

accountability and ISO 9001:2000 certified quality control procedures<br />

to everything we do, with zero tolerance for anything less<br />

than absolute customer satisfaction. FDA registered, ISO 9001:2000.<br />

randyroberts@microfinishusa.com<br />

www.microfinishusa.com<br />

MicroGroup, Inc. — Player CP LP MM MN RM SP<br />

7 Industrial Park Road<br />

Medway, MA 02053-1732<br />

USA<br />

508-533-4925 (phone)<br />

800-255-8823 (toll free)<br />

508-533-9881 (fax)<br />

blamson@microgroup.com<br />

www.microgroup.com<br />

Stainless Steel and Nickel-based Alloy Tubing. Stocking over<br />

7,000,000 feet of stainless steel, nickel alloy and titanium tubing<br />

under 1” in diameter, combined with in house redraw to size and<br />

shape means short lead times. Tube forming, bending, cnc bending,<br />

swiss type multi-axis machining, wire and ram edm, laser welding<br />

and cutting, passivation and electropolishing under one roof. Send<br />

your prints/requirements for an estimate. FDA-registered,<br />

ISO 9001:2000.<br />

Micropulse Incorporated MM MN MT<br />

briane@micropulseinc.com<br />

www.micropulseinc.com<br />

mgarrette@juno.com<br />

Millstone Medical Outsourcing LLC PA SO YY<br />

Minnesota Rubber/QMR Plastics MN<br />

1100 Xenium Lane North<br />

Minneapolis, MN 55441<br />

USA<br />

96 Ford Road<br />

Denville, NJ 07834<br />

USA<br />

952-927-1455 (phone)<br />

952-927-1470 (fax)<br />

973-627-7797 (phone)<br />

973-627-7809 (fax)<br />

stillman@millstonemedical.com<br />

www.millstonemedical.com<br />

bpederson@mnrubber.com<br />

www.mnrubber.com<br />

Miraclean Industries SP ST<br />

cheryl.larkin@verizon.net<br />

www.miraclean.com<br />

Modern Plastics, Inc. CA RM<br />

678 Howard Avenue<br />

Bridgeport, CT 06605<br />

USA<br />

203-333-3028 (phone)<br />

800-243-9696 (toll free)<br />

203-333-4625 (fax)<br />

bcarbone@modernplastics.com<br />

www.modernplastics.com


Exacting…by philosophy and design<br />

When your reputation and other peoples’ lives are dependent on the quality of the<br />

products you produce, Miltronics & Skye is the preferred supplier for small, highly engineered,<br />

complexly designed parts. We apply Six Sigma accountability and quality control<br />

procedures in accordance with ISO 9001 to everything we do, with zero tolerance for<br />

anything less than absolute customer satisfaction.<br />

From medical appliances and instruments to defense-industry and aerospace applications,<br />

our unique combination of customer-focused engineering and lean manufacturing<br />

ensures:<br />

• Optimum manufacturability<br />

• Consistently tight tolerances<br />

• Fast turnaround<br />

• Market-sensitive pricing<br />

• Reliable delivery<br />

• Improved profitability<br />

Engineering Parts — Perfect Performance<br />

Miltronics & Skye uses a solid modeling platform to facilitate hands-on interaction with<br />

your in-house product development team. Our inventive design engineers are experienced<br />

in a diverse spectrum of manufacturing methods and materials.<br />

If advanced design, precision engineering, and flawless manufacturing are your goals,<br />

we'd like to talk with you. Miltronics & Skye: pursuing perfection in the design and<br />

manufacture of small and geometrically complex parts.<br />

Advanced Capabilities<br />

• Design and Engineering • Laser Marking<br />

• Swiss CNC • Polishing<br />

• Standard Turning/Milling • Thread Rolling<br />

• Passivation • Wire EDM<br />

• Electropolish • 5 Axis Tool/Cutter Grinding<br />

• Heat Treat<br />

Certifications<br />

• Six Sigma/Lean Manufacturing • FDA Registered<br />

• ISO 9001:2000 • GMP<br />

Challenging Materials<br />

• Titanium • Cobalt Chrome<br />

• Implant-Grade Stainless Steel • Nitralloy<br />

<strong>The</strong> Sky’s the Limit<br />

As a Kilroy Company, Miltronics & Skye is part of Trust Technologies, an industry leader<br />

in the manufacture of precision-machined components, tools, and equipment for the<br />

aerospace, transportation, and power-generation industries. Precision engineering, lean<br />

manufacturing, and innovative partnering are the hallmarks of both organizations.<br />

Together, these Kilroy companies comprise decades of engineering design and manufacturing<br />

expertise committed to complete customer satisfaction. Our capabilities extend<br />

from the design and manufacture of small and complex parts to five-axis machining<br />

capabilities for larger diameter parts.<br />

For more information about the extended capabilities of Trust Technologies, visit<br />

www.trust-tech.com.<br />

Player Profile<br />

Miltronics & Skye<br />

A Wholly Owned Company<br />

of Trust Technologies<br />

9470 Pinecone Drive<br />

Mentor, OH 44060<br />

USA<br />

440-354-9595 (phone)<br />

440-354-8989 (fax)<br />

Web site<br />

www.miltronics-skye.com<br />

Founded<br />

1967<br />

Contacts<br />

Bill Stuart<br />

President<br />

bstuart@miltronics-skye.com<br />

Paul Cardinale<br />

Director of Sales<br />

sales@miltronics-skye.com<br />

Chris Rawlins<br />

Applications Engineer<br />

crawlins@miltronics-skye.com<br />

Ron Bate<br />

Director of Quality<br />

rbate@miltronics-skye.com<br />

Facilities<br />

67,000 sq.ft.<br />

Staff<br />

100 employees<br />

Certification<br />

FDA registered<br />

ISO 9001:2000<br />

BONEZone • Winter 2005 57


MO-NO<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

58 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

Morgan Advanced Ceramics - Alberox Products MN RM ST<br />

225 <strong>The</strong>odore Rice Boulevard<br />

New Bedford, MA 02745-1289<br />

USA<br />

St. Peter’s Road<br />

Warwickshire, CV21 3QR<br />

UK<br />

720 Mound Avenue<br />

COS-308<br />

Miamisburg, OH 45343<br />

USA<br />

14000 Technology Drive<br />

Eden Prairie, MN 55344-2290<br />

USA<br />

508-995-1725 (phone)<br />

508-995-6954 (fax)<br />

Morgan Advanced Ceramics - Bioceramic Products MM RM<br />

+44-(0)-1788-542166 (phone)<br />

+44-(0)-1788-579787 (fax)<br />

Mound Laser & Photonics Center, Inc. LP ST<br />

937-865-3730 (phone)<br />

937-865-3680 (fax)<br />

MTS Systems Corporation AT MN MT<br />

952-937-4000 (phone)<br />

952-937-4515 (fax)<br />

Nemcomed — Player MM MN<br />

801 Industrial Drive<br />

Hicksville, OH 43526<br />

USA<br />

419-542-7743 (phone)<br />

800-255-4576 (toll free)<br />

419-542-8931 (fax)<br />

jpritchard@nemcomedical.com<br />

www.nemcomed.com<br />

Development & Manufacture of Precision Medical Devices. Since<br />

1976, NEMCOMED has served a growing base of global as well as<br />

domestic clients. Our CNC machining capabilities enable us to provide<br />

close tolerance machining — especially for components and<br />

assemblies — by utilizing the most up-to-date cutting technologies.<br />

Our dedicated Custom Prototyping Division can meet your demand<br />

for quick turn around for customs, prototypes and short runs.<br />

FDA-registered, ISO 13485 in <strong>2006</strong>.<br />

New Concepts Prototyping and Production MM MN<br />

1311 North 35th Street<br />

Seattle, WA 98103<br />

USA<br />

35 Jeffrey Avenue<br />

Holliston, MA 01746<br />

USA<br />

508-429-9999 (phone)<br />

800-959-0341 (toll free)<br />

508-429-6850 (fax)<br />

rdesrosiers@nepg1.com<br />

www.nepg1.com<br />

206-633-3111 (phone)<br />

203-633-3114 (fax)<br />

Wire Products for Medical Science. NEPG provides medical device<br />

manufacturers with quality wire products and a wide array of precision<br />

manufacturing services. From stock medical wire to the development<br />

and manufacture of even the most complex components,<br />

we are prepared to be your one-stop source for wire based<br />

products. ISO 9001:2000.<br />

sales@morganplc.com<br />

www.alberox.com<br />

sales@morganadvancedceramics.com<br />

www.bioceramics.com<br />

kevinhartke@mlpc.com<br />

www.mlpc.com<br />

steve.trout@mts.com<br />

www.mts.com/bio<br />

larry@ncproto.com<br />

www.ncproto.com<br />

New England Precision Grinding - Player CP MM MN RM<br />

NFT Technology CA<br />

No. 88 Wei-Suei W.rd Kang Shan<br />

Kaohsiung, Heien<br />

Taiwan<br />

4643 North State Road 15<br />

Warsaw, IN 46582<br />

USA<br />

+886-7-6230183 (phone)<br />

+886-7-6228648 (fax)<br />

NGInstruments, Inc. MN<br />

574-268-2112 (phone)<br />

574-268-0253 (fax)<br />

Norwood Tool Company — Player MM MN<br />

2122 Winners Circle<br />

Dayton, OH 45404<br />

USA<br />

937-228-4101 (phone)<br />

937-228-1608 (fax)<br />

jmueller@norwoodtool.com<br />

www.norwoodtool.com<br />

Service@nft.com.tw<br />

www.nft.com.tw<br />

CNC Machining, Metal Stamping, Assembly and Nitinol Processing<br />

for the Medical Community. Two state of the art facilities with over<br />

113,000 sq. ft. and the latest technology allow us to take products<br />

from concept/prototype through production. Producing instruments<br />

and implants for over 25 years utilizing a wide variety of materials<br />

such as: Stainless, Titanium, Cobalt chrome, Nitinol and plastics.<br />

FDA-registered, ISO 9001:2000 (ANSI/ASQC 9001), QS 9000, AS 9000.<br />

tnicholas@nginstruments.com<br />

www.nginstruments.com


People<br />

Founded in 1976, Nemcomed manufactures and develops precision medical devices<br />

in the areas of spine, trauma, reconstructive joint replacement and sports medicine.<br />

Our dedicated focus enables us to provide premier solutions for our medical industry<br />

partners.<br />

We are focused on making your products better and providing innovative solutions.<br />

Making the Difference<br />

Manufacturing Technology – Print to Package<br />

Specialist in management of multiple large scale launches – on time, on budget<br />

• Fully capable in early prototyping thru high volume production<br />

• Bone Screw Manufacturing – utilizing advanced manufacturing technologies<br />

• Trauma and Spinal Plate – manufactured with the latest technologies<br />

• Experienced with Metal-on-Metal bearing surfaces<br />

• Implants – expertise in broad range of products across the industry<br />

• Instruments – proven industry leader in one piece components thru complex<br />

assemblies<br />

R & D Technology – Concept thru Packaging<br />

• Significant Product Development experience across the industry<br />

• Proven ability to execute large scale implant / instrument projects concept thru<br />

regulatory approval<br />

• Our ideas or yours<br />

Value Driven – Customer Focused<br />

• Honesty and Integrity<br />

• Striving to be the best from our customer’s perspective<br />

• Innovative, yet Practical<br />

Investing for the Future<br />

“Be the Premier Medical Solutions Provider”<br />

• People<br />

• Processes and Technologies<br />

• Facilities - Second facility dedicated to R&D and Advanced Manufacturing opening<br />

Fall of <strong>2006</strong> in Fort Wayne, Indiana<br />

Orthopaedic Splints and Bracing<br />

Nemcomed also offers a full line of orthopaedic splints and bracing. Our aluminum<br />

splint line is both x-ray translucent and malleable, for a form fit. <strong>The</strong> foam padding and<br />

electrostatic powder coating enhance the comfort fit. Ask about our full line of finger,<br />

hand, arm and leg splints.<br />

Player Profile<br />

Nemcomed<br />

801 Industrial Drive<br />

Hicksville, OH 43526<br />

USA<br />

419-542-7743 (phone)<br />

800-255-4576 (toll-free)<br />

419-542-8931 (fax)<br />

Web site<br />

www.nemcomed.com<br />

Founded<br />

1976<br />

Contacts<br />

Jim Pritchard<br />

VP, Sales & Marketing<br />

jpritchard@nemcomedical.com<br />

Scott Edwards<br />

Sales Manager<br />

sedwards@nemcomedical.com<br />

Facility<br />

51,000 sq. ft.<br />

Certification<br />

FDA-registered<br />

ISO 13485 in <strong>2006</strong><br />

Products available to our<br />

partners<br />

• MIS Knee Retractors<br />

(2 different sets)<br />

• Shoulder Retractors<br />

• Self Retaining Screwdrivers<br />

• Hip Stem Inserter<br />

• Hip Extractor<br />

Products coming soon<br />

• Screw Removal Set<br />

• Expanded Self Retaining<br />

Screwdriver Styles<br />

• Flexible Drive Shafts<br />

• No-Clog Suction Device<br />

BONEZone • Winter 2005 59


NU-PA<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

152 Collins Street<br />

Memphis, TN 38112<br />

USA<br />

901-323-6699 (phone)<br />

901-454-0295 (fax)<br />

jodieg@onyxmedical.net<br />

www.onyxmedical.net<br />

1001 Oakwood Boulevard<br />

Round Rock, TX 78681<br />

USA<br />

60 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

Nuell, Inc. MN<br />

PO Box 55<br />

Warsaw, IN 46581<br />

USA<br />

2262 Calle del Mundo<br />

Santa Clara, CA 95054<br />

USA<br />

2301 Silverville Road<br />

Freeport, PA 16229-0315<br />

USA<br />

724-295- 0277 (phone)<br />

724-295-0395 (fax)<br />

shawn.schafer@oberg.com<br />

www.oberg.com<br />

704 South 21st Street<br />

Irvington, NJ 07111<br />

USA<br />

973-372-1090 (phone)<br />

973-372-1091 (fax)<br />

info@pakmanufacturing.com<br />

www.pakmanufacturing.com<br />

574-453-4900 (phone)<br />

574-453-3797 (fax)<br />

408-674-1060 (phone) harry@nu-metalfinishing.com<br />

www.nu-metalfinishing.com<br />

Provide Technological Leadership and Manufacturing Solutions... to<br />

support OEMs focused on Orthopaedic, Spinal and Trauma Markets.<br />

Specialize in precision grinding, multi-axis machining, wire and<br />

plunge EDM,near-net stamping, surface finish development, and<br />

automated manufacturing and assembly systems. A $100 million<br />

company, employing over 600 craftsmen, that supports volume<br />

product launches, prototype and first article development. ISO<br />

9001:2000.<br />

Strategic Manufacturing Support for the Orthopaedic Industry. A<br />

trusted supplier to leading orthopaedic companies worldwide for<br />

wires, guide pins, half pins, drills and screws manufactured from<br />

stainless steel, titanium, cobalt chrome and nitinol. Complete finishing,<br />

etching, packaging and inventory management services offered.<br />

1001 Oakwood Boulevard. Strict adherence to FDA cGMP with an<br />

ISO 13488:2000 certified Quality System. FDA Registered.<br />

OrthoMedix Group YY<br />

512-388-0199 (phone)<br />

512-388-0199 (fax)<br />

Custom & Specialty Handheld Surgical Instruments. Hand-finished,<br />

forged surgical instruments made in the USA! We specialize in custom<br />

configurations, built from raw forgings (not other instruments).<br />

Prototypes often shipped within ten days for your approval; production<br />

quantities typically shipped within eight weeks. In-house manufacturing<br />

capabilities include milling, grinding, heat treating, passivation,<br />

polishing. FDA-registered.<br />

dch@nuellinc.com<br />

www.nuell.com<br />

Nu-Metal Finishing ST<br />

Oberg Industries — Player DS MM MN MT YY<br />

Onyx Medical Corporation — Player MM MN<br />

PAK Manufacturing, Inc. — Player MN<br />

PAK Orthopaedics, Inc. — Player DS MM MN MR<br />

301 Route 17 North, Suite 800<br />

Rutherford, NJ 07070<br />

USA<br />

973-372-1090 (phone)<br />

973-372-1091 (fax)<br />

info@pakgroup.net<br />

www.pakgroup.net<br />

8 Matchett Industrial Park Drive<br />

Pierceton, IN 46562<br />

USA<br />

574-594-2140 (phone)<br />

800-225-6975 (toll free)<br />

574-594-2154 (fax)<br />

info@paragonmedical.com<br />

www.paragonmedical.com<br />

OEM Manufacturing Services. Primary Product Supply & OEM<br />

Representation of Manufacturers to the Orthopaedic Industry Since<br />

1990. Capabilities include sophisticated and complex CNC machining,<br />

high performance ground cutting tools, specialty and custom<br />

hand-held (forged) instruments, premium metal sterilization cases<br />

and trays and close tolerance machining of plastic implants and trials.<br />

Turnkey systems or fabrication to your specs. FDA-registered.<br />

Instrumental in Your Success. Single source turnkey surgical instrument,<br />

implantable component & delivery system solution. Advanced<br />

manufacturing technology, UG(r) certified engineers, rapid prototyping,<br />

virtual information transfer, vertical integration & experience<br />

allow us to adapt our services to support your strategic needs with<br />

innovative solutions. U.S. & European offices. FDA-registered,<br />

ISO 9001:2000, FDA 510(k) cleared cases.<br />

ortho.medix@sbcglobal.net<br />

www.orthosupplier.com/profiles/<br />

orthomedix-group2.htm<br />

Paragon Medical, Inc. — Player AT DS LP MM MN PA SP ST


What do you want to accomplish?<br />

Onyx Medical Corporation is dedicated to being your strategic partner — helping you<br />

bring new prototype ideas to life, developing new ways to meet your manufacturing<br />

goals and producing high-quality precision trauma parts.<br />

Our FDA-registered and ISO-certified facility in Memphis, Tennessee, offers customers<br />

unparalleled access to worldwide distribution and specializes in manufacturing comprehensive<br />

lines of wires, guide pins, half pins, drills and screws. Onyx’s engineering team<br />

can also assist in the manufacturability of your most challenging parts.<br />

Our goal is to provide a total solution of the highest value — one that includes<br />

superior quality products, enhanced customer service, reliable quotes and delivery,<br />

and impeccable performance of both your finished parts and our quality team.<br />

Customized Services and Solutions<br />

• Complete design-to-dock outsourcing solutions<br />

• Prototyping and design for manufacturing feasibility<br />

• Inventory management and stocking programs<br />

• Precision turning, grinding and milling<br />

• Close-tolerance manufacturing on diameters from .028-.375”<br />

• Forging, threading, broaching, glass beading<br />

• Electropolishing, passivation, custom coatings<br />

• Heat treating, epoxy inking, laser and chemical etching<br />

• Packaging with inserts and labels, shrink-wrapping<br />

Materials<br />

Implant Grade: 316L Stainless Steel, Ti 6Al-4V ELI Titanium, L605 Cobalt Chrome,<br />

22-13-5 Stainless Steel, Nitinol (NiTi Shape Memory Alloy)<br />

Medical Instrument Grade: 630, 440 series and 455 Stainless Steel<br />

Products<br />

Fixation: half pins, fixation pins, one-piece olive wires, reduction wires, threaded<br />

and plain K-Wires and Steinmann Pins, locating pins, specialty screws, suture anchors<br />

Nailing: one-piece ball tips, guide wires and guide pins<br />

Cutting: specialty drills, taps, drill point pins and wires<br />

Commitment to Quality<br />

Your Needs. Our Focus.<br />

• Independent lab testing of raw materials<br />

• Manufacturing to all print specifications<br />

• Realistic lead times and quotations that are honored<br />

We never forget that your name<br />

is on every product we manufacture.<br />

Player Profile<br />

Onyx Medical Corporation<br />

152 Collins Street<br />

Memphis, TN 38112<br />

USA<br />

901-323-6699 (phone)<br />

901-454-0295 (fax)<br />

Founded<br />

1990<br />

Contacts<br />

Laraine B. Gilmore<br />

President<br />

Jodie B. Gilmore<br />

Vice President,<br />

Sales & Marketing<br />

jodieg@onyxmedical.net<br />

Staff<br />

54 employees<br />

Certification<br />

FDA-registered<br />

EN ISO 13488:2000<br />

ISO 13485:2003 (in process)<br />

BONEZone • Winter 2005 61


Oberg Industries<br />

2301 Silverville Road<br />

P.O. Box 368<br />

Freeport, PA 16229-0315<br />

USA<br />

724-294-1277 (phone)<br />

724-295-0395 (fax)<br />

inquire@oberg.com<br />

Web site<br />

www.oberg.com<br />

Founded<br />

1948<br />

Sales<br />

Over $100 million<br />

Contacts<br />

Shawn Schafer<br />

Director of Marketing and<br />

Strategic Planning<br />

shawn.schafer@oberg.com<br />

Rick Black<br />

Vice President Sales<br />

rick.black@oberg.com<br />

Facility<br />

Corporate headquarters,<br />

Freeport, PA<br />

Over 400,000 sq. ft. of<br />

manufacturing space with<br />

facilities in Pennsylvania,<br />

Arizona and Costa Rica<br />

Staff<br />

Over 650<br />

Certification<br />

ISO 9001:2000<br />

Player<br />

Profile<br />

62 BONEZone • Winter 2005<br />

Manufacturing and Technology Solutions<br />

Bring Manufacturing and Technology Solutions to OEMs<br />

in the Orthopaedic Market<br />

By integrating our people, processes, and capabilities such as multi-axis and EDM<br />

machining, surface finishing, grinding, stamping, and assembly we are able to develop<br />

unique manufacturing solutions to satisfy our customers production requirements<br />

beyond their expectations.<br />

Our value-added/value-engineering (VAVE) team and skilled craftsmen work with you to<br />

analyze existing or new product designs and develop new methods of manufacturing to<br />

achieve on-going productivity gains. <strong>The</strong> results can range from superior finishes on<br />

ultra-hard materials to reduced cycle times and improved quality and consistency from<br />

part to part.<br />

Oberg’s Orthopaedic Market Solutions<br />

• Joint Replacement<br />

- Implants, Trial Components for the<br />

Hip, Knee, and Shoulder<br />

• Spine<br />

- Implants, Rods, Plates, Screws<br />

Material<br />

Experienced with machining, EDMing, stamping, and forming of titanium, stainless steel,<br />

cobalt chrome, ceramic, nitinol, platinum and other super alloys.<br />

High-speed multi-axis<br />

machining centers.<br />

Twin wire and robotic plunge<br />

EDM technology.<br />

• Trauma<br />

- Fixation Plates, Rods,<br />

Screws, Nails<br />

• Instruments<br />

- Cutting Blocks, Trocars,<br />

Sharps, Needles<br />

Zeiss CMM provides 3-D<br />

profiling.


Robotic Abrasive Belt Polishing and Buffing<br />

Pinnacle Technologies is the world leader in robotic deburring, abrasive belt polishing and buffing<br />

systems for orthopaedic components. We provide powerful solutions through unparalleled service,<br />

support and training. When you work with us, you will tap into decades of innovations and<br />

advancements.<br />

System Design and Advantages<br />

• Heavy duty double walled platform precision welded structure<br />

• Laser Cut Reference Housings<br />

• No Floor Bolting Required with our leveling system<br />

• Integrated safety cabin and dust collection<br />

• Assembled size 2430mm x 3353mm (fits 20ft Container)<br />

• Easy factory relocation without reprogramming<br />

• Extremely accurate references<br />

• Electrical wiring inside double walled platform<br />

• Easy cleaning and wire free footprint<br />

• Easy to retrofit for future developments<br />

• Single and double stacked belt units<br />

• Free belt and deburring attachment options<br />

• Large diameter shaft and bearings (for continuous duty cycles and very low<br />

maintenance cost)<br />

• Dust extraction hoods with 2 or 3 outlets<br />

ABRASIVE BELT UNIT FEATURES<br />

• <strong>The</strong> contact wheel is direct driven (facilitates use of non-woven abrasive wheels, buffing<br />

wheels etc.)<br />

• One inverter per electric drive motor<br />

• Contact wheel protection system<br />

• Easy adjustment system for different belt lengths from 3200 mm<br />

up to maximum 4000 mm.<br />

• Maximum contact wheel face width of 120 mm.<br />

• Precision belt tracking and tensioning<br />

• Fully programmable pressure control system with belt cooling<br />

and lubricating system which increases belt life up to 300%<br />

BUFFING UNIT<br />

• Direct driven spindle with large diameter shaft<br />

• Large diameter buffing wheels, up to 1000 mm and 8-10 weeks<br />

buff life<br />

• Low heat generation<br />

• Closed loop feed back system for buff wear compensation using<br />

brushless motors and high<br />

precision ball screw components.<br />

• System automatically maintains constant SFM and a constant<br />

programmed pressure while following the part contour<br />

SOFTWARE, HARDWARE and SERVICE<br />

• System software access supplied<br />

• Remote troubleshooting via Internet<br />

• Ability to download software files, part programs and<br />

parameters from service website<br />

• Rapid response to service calls<br />

• Spare parts list for all commercial and Pinnacle components<br />

• Pinnacle components dispatched within 24 hours<br />

• Instruction and maintenance manuals provided (also available<br />

online )<br />

• Robotic Offline Programming System<br />

• Unique calibration software - robot programs can be transferred<br />

from one robotic cell to another without requiring touch up<br />

• Laser gauging system for part recognition and measurement<br />

• Universal tooling design with heavy duty construction specifically<br />

for abrasive polishing and buffing applications<br />

Player Profile<br />

Pinnacle Technologies, Inc.<br />

681 Lawlins Road - Bay 140<br />

Wyckoff, NJ 07481<br />

USA<br />

201-891-7049 (phone)<br />

201-891-7930 (fax)<br />

bpenque@pinnacletechnologies.com<br />

Web site<br />

www.pinnacletechnologies.com<br />

Facility<br />

40,000 sq.ft. manufacturing<br />

facility<br />

Founded<br />

1989<br />

Contacts<br />

Robert Penque<br />

President<br />

Mark Bergonzi<br />

General Manager<br />

Enrico Colombo<br />

International Director of Sales<br />

Robotic Applications<br />

Silvio Vanali<br />

Robotics Systems Product<br />

Manager<br />

Stefano Pedretti<br />

Software Development Manager<br />

Lance Thomas<br />

Technical Service Manager<br />

Alex Grazioli<br />

Robotic Programming &<br />

Applications Manager<br />

BONEZone • Winter 2005 63


PE-PR<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

Grove Mill, Todmorden Road<br />

Bacup<br />

Lancashire OL13 9EF<br />

UK<br />

64 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

Penn Manufacturing Industries MM MN<br />

506 Stump Road<br />

Montgomeryville, PA 18936<br />

USA<br />

Penn United Technology Inc. MT RM ST<br />

799 North Pike Road<br />

Cabot, PA 16023<br />

USA<br />

Perplas Ltd. RM<br />

213 Vandale Drive<br />

Houston, PA 15342<br />

USA<br />

724-352-6550 (phone)<br />

724-352-4970 (fax)<br />

+44-(0)-1706-874171 (phone)<br />

+44-(0)-1706-879826 (fax)<br />

724-746-9390 (phone)<br />

724-746-9392 (fax)<br />

Doug_Sproat@Pennunited.com<br />

www.pennunited.com<br />

brooks@perplas.com<br />

www.perplas.net<br />

Perryman Company RM<br />

Phillips Precision, Inc. / MediCraft — Player DS MM MN<br />

7 Paul Kohner Place<br />

Elmwood Park, NJ 07407<br />

USA<br />

201-797-8820 (phone)<br />

201-797-3039 (fax)<br />

mphillips@phillipsprecision.com<br />

www.phillipsprecision.com<br />

Custom Implants, Instruments, Sterilization Cases & Trays. Phillips<br />

Precision has manufactured advanced orthopaedic implants &<br />

instruments for over 40 years. CNC milling, turning, screw machining;<br />

wire/RAM EDM; TiG welding; laser marking; passivation; CNC<br />

brake bending & turret punching. MediCraft develops/manufactures<br />

custom instrument cases, trays and racks, and introduced the<br />

“industry standard” rounded corner, recessed handle design.<br />

Both companies ISO 9001:2000 certified.<br />

Pinnacle Technologies, Inc. MT<br />

Pinnacle Technologies, Inc.<br />

681 Lawlins Road, Bay 140<br />

Wyckoff, NJ 07481<br />

USA<br />

201-891-7049 (phone)<br />

201-891-7930 (fax)<br />

bpenque@pinnacletechnologies.com<br />

www.pinnacletechnologies.com<br />

375 River Park Circle<br />

Marquette, MI 49855<br />

USA<br />

6859 North Foothills Highway<br />

Boulder, CO 80302<br />

USA<br />

50 Raymond<br />

Waterville, Quebec J0B 3H0<br />

Canada<br />

Robotic Abrasive Belt Polishing and Buffing. Robotic finishing cells<br />

designed around your specific needs. We combine cutting-edge technology<br />

with hands-on experience in automated polishing & buffing<br />

to provide powerful solutions through unparalleled service, support<br />

and training. Robotic finishing cells are competitively priced and<br />

backed by a guaranteed 24-hour turnaround service. Units are preassembled,<br />

pre-wired, pre-programmed.<br />

Pioneer Surgical Technology MM MN<br />

906-226-9909 (phone)<br />

906-226-4443 (fax)<br />

303-415-9865 (phone)<br />

303-415-9866 (fax)<br />

819-837-2491 (phone)<br />

819-837-1095 (fax)<br />

pbunten@perrymanco.com<br />

www.perrymanco.com<br />

sales@pioneersurgical.com<br />

www.pioneersurgical.com<br />

Point Technologies, Inc. MM MN RM SP ST<br />

PPD Meditech MM MN<br />

102 Pickering Way, Suite 508<br />

Exton, PA 19341<br />

USA<br />

610-524-8300 (phone)<br />

610-524-6559 (fax)<br />

b.lyons@precimed.com<br />

www.precimed.com<br />

215-362-1217 (phone)<br />

215-362-3918 (fax)<br />

Precimed, Inc. — Player DS FO MM MN<br />

Design, Development & Manufacture of Precision Surgical Products.<br />

Founded in 1988, Precimed is focused on the manufacture of<br />

implants and instruments for orthopaedic and trauma surgery.<br />

Reamers, drill and taps, broaches, handles, screwdrivers, screws,<br />

trauma sets. U.S. FDA-registered facilities opened in 1998.<br />

Worldwide sales and support including Europe, North & South<br />

America, Africa, Asia & India. FDA-registered, ISO 9001:2000, ISO<br />

13485:2003, EN 46001, CE Mark.<br />

naveentodi@pennmfg.com<br />

www.pennmfg.com<br />

jobrien@pointtech.com<br />

www.pointtech.com<br />

grepye@ppdgroup.com<br />

www.ppdgroup.com


Design, Development, & Manufacture of Precision Surgical Products<br />

Design and development expertise<br />

(copyrighted, patented and<br />

trademarked products)<br />

Full-service contract manufacturing<br />

Product Range<br />

Reamers<br />

Acetabular, patella, glenoid and calcar<br />

Straight or flexible intramedullary reamers<br />

Drills and Taps<br />

Twist, flexible and cannulated<br />

Manufacturing Capabilities<br />

• milling (up to 6-axis)<br />

• grinding (up to 6-axis)<br />

• turning (up to 20-axis)<br />

• long turning<br />

• laser cutting<br />

• laser welding<br />

• laser marking<br />

• silicone over-molding<br />

• plastic injection molding<br />

• MIM - metal injection molding<br />

• automated passivation<br />

• punching/stamping<br />

• sheet metal forming<br />

• wire EDM<br />

• finishing – full range of surface finishes<br />

(MASS, electropolish, glass bead blast,<br />

tumble, etc.)<br />

• packaging and labeling<br />

• dock-to-stock<br />

Broaches<br />

Our new broach tooth concept with continuous helical tooth pattern -<br />

tooth size adjusts progressively so that the distal teeth are finer and the proximal teeth<br />

are more aggressive. This distributes the teeth to provide a more efficient cut.<br />

Handles<br />

Quick-connect and ratcheting handles, angled drivers, flexible shaft and<br />

bayonet-mount modular tools<br />

Screwdrivers<br />

Straight, u-joint, cannulated, flexible/reversible<br />

Screws and Plates<br />

Custom or standard bone screws and plates<br />

Trauma Sets<br />

Acetabular Instrument, Mini Fragment, Small Fragment, Basic Fragment,<br />

Compression Plate, Cannulated<br />

Minimally-Invasive Instrumentation<br />

Hip, Knee, Trauma, Spine<br />

Columbia City, IN facility<br />

Player Profile<br />

Precimed S.A.<br />

L’Echelette 7<br />

CH - 2534 Orvin<br />

Switzerland<br />

+41-32-358-01-11 (phone)<br />

+41-32-358-01-00 (fax)<br />

sales@precimed.com<br />

Precimed, Inc.<br />

102 Pickering Way, Suite 508<br />

Exton, PA 19341<br />

USA<br />

610-524-8300 (phone)<br />

610-524-6559 (fax)<br />

precimed_usa@precimed.com<br />

Web site<br />

www.precimed.com<br />

Founded<br />

1988<br />

Certification<br />

FDA-registered<br />

ISO 9001:2000<br />

ISO 13485:2003<br />

EN 46001<br />

CE Mark<br />

Focus<br />

Implants and instruments for trauma,<br />

spine and reconstructive orthopaedic<br />

surgical protocols<br />

Background<br />

PRECIMED is a high-growth manufacturer<br />

and developer of surgical orthopedic products.<br />

Global operations are headquartered<br />

in Switzerland with facilities in the US, UK,<br />

Japan, and Asia.<br />

Precimed began as a precision cutting tool<br />

manufacturer and became an independent<br />

private entity in 1988. With over 20 years<br />

experience in the medical field current certifications<br />

include EN46001, ISO9001 and<br />

ISO 13485; Precimed carries the CE mark<br />

for all standard products and are an FDA<br />

registered company.<br />

Manufacturing sites include state-of-the-art<br />

equipment, including full product surface<br />

finishing capabilities, automated product<br />

flow controls, state-of-the-art CAD/CAM<br />

interface, and extensive industry experience<br />

and applications expertise. A wellestablished<br />

research and development<br />

team relies on state-of-the-art technology<br />

to provide innovative and cutting edge<br />

design and development solutions to customers<br />

and the orthopedic industry. This<br />

includes a focus on the creation and<br />

development of intellectual property.<br />

With over 260 customers worldwide, sales<br />

and support include Europe, North and<br />

South America, Africa, Asia and India.<br />

BONEZone • Winter 2005 65


PR-RA<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

415 West 12th Avenue<br />

Sault Ste Marie, MI 49783<br />

USA<br />

906-632-4800 (phone)<br />

906-632-5619 (fax)<br />

rpete@precisionedge.com<br />

www.precisionedge.com<br />

128 Market Street<br />

Saddle Brook, NJ 07663<br />

USA<br />

201-843-7427 (phone)<br />

201-843-9235 (fax)<br />

sales@gopmmi.com<br />

www.gopmmi.com<br />

850 West Bradley Avenue<br />

El Cajon, CA 92020<br />

USA<br />

619-448-2711 (phone)<br />

619-448-2005 (fax)<br />

jimm@pmpnj.com<br />

www.pmp-elcajon.com<br />

66 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

Precision Castparts Corp. CA FO<br />

4600 Southeast Harney Drive<br />

Portland, OR 97267<br />

USA<br />

Precision Edge Surgical Products Company LLC — Player MM MN SP ST<br />

515 Argonne Road<br />

Warsaw, IN 46580<br />

USA<br />

50 Maple Street<br />

Norwood, NJ 07648<br />

USA<br />

201-767-1600 (phone)<br />

201-767-6739 (fax)<br />

lwhitney@ptiplastics.com<br />

www.ptiplastics.com<br />

Manufacturer of Surgical Cutters, Instruments & Implants. Small and<br />

large bone cutting tools including blades, burs, drills, reamers, Kwires,<br />

trocars, taps, screws, etc. Custom products including instruments<br />

& implants for joint and spine. CNC machining and grinding,<br />

laser cutting, welding and marking, Swiss turning, milling, stamping,<br />

EDM, gundrilling, electropolish, passivating, FPI, coatings, sterile<br />

packaging. ISO 9001:2000 certified.<br />

Precision Metal Machining, Inc. — Player MM MN<br />

PMMI specializes in the production of orthopaedic instruments and<br />

implants. We have developed a talented team that has a broad<br />

base of knowledge in machining exotic materials including titanium,<br />

cobalt chrome and plastics. At PMMI, we excel in producing quantities<br />

that range from prototypes to full production runs. We can also<br />

offer assistance during the design & development process to control<br />

costs. ISO 9001:2000 certified.<br />

Precision Metal Products, Inc. — Player FO MM MN SP ST<br />

Orthopaedic Implant Forgings in Titanium, Cobalt-Chrome-<br />

Molybdenum, Stainless Steel and Customer Specific Alloys. Our inhouse<br />

capabilities include heat treating, lab testing, 4-axis and 5axis<br />

CNC machining, chemical milling, secondary finishing operations<br />

and complete tool design and fabrication. We are ISO<br />

9001:2000 certified.<br />

Precision Technology of Warsaw, LLC MM MN<br />

574-269-1120 (phone)<br />

574-269-4850 (fax)<br />

Precision Technology, Inc. — Player MM<br />

Innovation in Plastics Machining. Orthopaedic Implants, Trial<br />

Components and Surgical Support Instrumentation. Our plastics<br />

machining processes provide exceptional quality, timely delivery and<br />

better ROI from your overall manufacturing expenditure. PTI<br />

Fabrication Mediums: Celcon®, Delrin®, LEXAN®, PEEK,<br />

polypropylene, Radel®, Teflon® PTFE, UHMWPE and cross-linked<br />

UHMWPE, Ultem®. Our plant operates 24/7. FDA-registered.<br />

203-925-8525 (phone)<br />

800-297-8665 (toll free)<br />

203-925-8535 (fax)<br />

info@ptwarsaw.com<br />

www.ptwarsaw.com<br />

Preferred Tool and Die, Inc. MM MN MT<br />

30 Forest Parkway<br />

Shelton, CT 06484<br />

USA<br />

714-546-4045 (phone)<br />

714-546-1109 (fax)<br />

info@preferredtool.com<br />

www.preferredtool.com<br />

Pro-Dex/Micro Motors MN YY<br />

151 East Columbine<br />

Santa Ana, CA 92707<br />

USA<br />

11125 Yankee Road<br />

Centerville, OH 45458<br />

USA<br />

503-794-2053 (phone)<br />

800-628-6656 (toll free)<br />

503-794-2047 (fax)<br />

RAM Medical Solutions MM MN<br />

937-885-7700 (phone)<br />

937-885-7727 (fax)<br />

rlittle@pcc-structurals.com<br />

www.precast.com<br />

jim.mckenney@pro-dex.com<br />

www.pro-dex.com<br />

sales@ram-ms.com<br />

www.ram-ms.com


Innovation in Plastics Machining<br />

Orthopaedic Implants, Trial Components<br />

and Surgical Support Instrumentation<br />

PTI is a precision plastics machining house with a concentration in medical device and<br />

implant manufacturing technology. Our plastics machining processes are able to provide<br />

exceptional quality, timely delivery and a better ROI from your overall manufacturing<br />

expenditure. When bringing your high quality orthopaedic or medical device products to<br />

market, take advantage of the numerous advantages PTI offers such as:<br />

• Control over Costs: Standardize your manufacturing costs with an outsourced<br />

partner. PTI’s only business is your manufacturing. Take advantage of this core<br />

competency and leverage it in your model.<br />

• Supreme Quality: With our state of the art manufacturing facility, internal quality<br />

control manual and the very best in machines, PTI is able to provide a higher<br />

level of quality<br />

• Available Collaborative Engineering: PTI offers substantial engineering guidance<br />

for clients. Leverage our 31 years of plastics machining experience in your design<br />

stages. PTI offers dedicated client portals for all clients.<br />

• 24/7 Plant Operations: PTI is able to accommodate the largest and most<br />

sophistcated manufacturing jobs. Our 52,000 sq. ft. manufacturing facility allows<br />

high output levels. We are able to provide consistent delivery of “any material —<br />

any design” throughout our relationships.<br />

• A Dedicated and Expeditious Industry Partner: A common theme of precise<br />

quality, advancement in manufacturing technologies and a quantifiable ROI for all<br />

clients exists throughout our organization. PTI has developed long-term partner<br />

ships with the largest orthopaedic device and implant companies in the world.<br />

Leverage our collective years of manufacturing expertise.<br />

PTI Fabrication Mediums: Celcon®, Delrin®, LEXAN®, PEEK, polypropylene, Radel®,<br />

Teflon® PTFE, UHMWPE and cross-linked UHMWPE, Ultem®.<br />

• Celcon® is a registered trademark of Ticona.<br />

• Delrin® is a registered trademark of DuPont.<br />

• LEXAN® is a registered trademark of GE Plastics.<br />

• PEEK is a trademark of Victrex®.<br />

• Radel® is a registered trademark of Solvay Advanced Polymers.<br />

• Teflon® PTFE is a registered trademark of DuPont.<br />

• Ultem® is a registered trademark of GE Plastics.<br />

Player Profile<br />

Precision Technology, Inc.<br />

50 Maple Street<br />

Norwood, NJ 07648-2004<br />

USA<br />

201-767-1600 (phone)<br />

201-767-6739 (fax)<br />

Web site<br />

www.ptiplastics.com<br />

Founded<br />

1971<br />

Contacts<br />

Ira Housman<br />

President/CEO<br />

ihousman@ptiplastics.com<br />

Larry Whitney<br />

Vice President/<br />

Chief Operating Officer<br />

lwhitney@ptiplastics.com<br />

John Effertz<br />

Plant Manager<br />

jeffertz@ptiplastics.com<br />

Orlando Lopez<br />

Manager, Quality Assurance<br />

olopez@ptiplastics.com<br />

Robert Boyce<br />

Controller<br />

rboyce@ptiplastics.com<br />

Facility<br />

52,000 sq. ft.<br />

Certification<br />

FDA-registered<br />

Focus<br />

medical device and<br />

implant manufacturing<br />

Recognition<br />

2001 “Machining <strong>Supplier</strong> of the<br />

Year” [Smith and Nephew]<br />

BONEZone • Winter 2005 67


RI-SA<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

Grand-Rue 53<br />

Corgemont, 2606<br />

Switzerland<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

Rickman Tool, Inc. — Player MM MN<br />

1202 East 4th Street<br />

Rochester, IN 46975<br />

USA<br />

574-223-8198 (phone)<br />

574-223-8125 (fax)<br />

m.faylor@rickmantool.com<br />

www.rickmantool.com<br />

Riley Medical AT DS PA<br />

27 Wrights Landing<br />

Auburn, ME 04210<br />

USA<br />

Riley Medical Europe AT DS LP PA<br />

8600 Evergreen Boulevard<br />

Minneapolis, MN 55433<br />

USA<br />

207-384-5973 (phone)<br />

800-245-3300 (toll free)<br />

207-786-5553 (fax)<br />

+41/324-881-010 (phone)<br />

+41/324-881-000 (fax)<br />

763-7861520 (phone)<br />

763-786-1305 (fax)<br />

melinoc@rileymedical.com<br />

www.rileymedical.com<br />

sales@rileyeurope.com<br />

www.rileyeurope.com<br />

RMS MM MN PA ST<br />

bjohnson@machine.com<br />

www.rmsmachining.com<br />

RSB Alloy Applications, LLC YY<br />

1137 Dunkelberger Road<br />

Leesport, PA 19533<br />

USA<br />

610-926-7976 (phone)<br />

610-916-0951 (fax)<br />

robert_s_brown@earthlink.net<br />

www.orthosupplier.com/profiles/<br />

rsb-alloy-applications2.htm<br />

RTI International Metals, Inc. RM<br />

1000 Warren Avenue<br />

Niles, OH 44446<br />

USA<br />

151 Old New Brunswick Road<br />

Piscataway, NJ 08854<br />

USA<br />

732-752-8300 (phone)<br />

732-752-8315 (fax)<br />

golamco@sswt.com<br />

www.sswhitemedical.net<br />

123 Moore Road<br />

Weymouth, MA 02189<br />

USA<br />

781-335-5300 (phone)<br />

781-340-0517 (fax)<br />

bcorreia@sagerpt.com<br />

www.sagerprecision.com<br />

330-544-7791 (phone) dbertko@rtiintl.com<br />

www.rtiintl.com<br />

S.S. WHITE® Medical Products Inc. — Player MN<br />

Custom Orthopaedic Surgical Instrumentation. A world class leader<br />

in the design and manufacture of surgical instrumentation. Our full<br />

service facility provides you with speedy turn around for prototypes<br />

and production orders. Years of service have earned us the trust<br />

and respect of the largest surgical orthopaedic implant manufacturers<br />

worldwide for their contract manufacturing needs. FDA Medical<br />

Device Manufacturer, CGMP and ISO 9001:2000 certified.<br />

Sager Precision Technologies, Inc. — Player LP MM MN SP ST<br />

PO Box 1220<br />

Scranton, PA 18501-1220<br />

USA<br />

1917 South Lynnwood Drive East<br />

Warsaw, IN 46580-7557<br />

USA<br />

Orthopaedic Implants, Spinal Products & Medical Devices. Rapid<br />

prototyping, automated spherical lapping/polishing, multi-pallet horizontal<br />

milling, ultraprecision machining, twin spindle turning, Class<br />

100/1000 clean room inspection & packaging, electromechanical<br />

assembly & testing, laser marking, titanium anodizing, passivating,<br />

electropolishing. Inventory programs thru MRP, JIT, Kanban, EDI for<br />

“Dock to Stock” programs. FDA-registered, ISO 9001:2000;<br />

13485:2003, EN46001.<br />

Sandvik Materials Technology RM<br />

570-585-7727 (phone) curt.nicolio@sandvik.com<br />

www.smt.sandvik.com/bioline<br />

Satterley & Associates, LLC CA DS MM MN MR MT RM ST<br />

68 BONEZone • Winter 2005<br />

Manufacturer of Precision Orthopaedic Products. A family-owned precision<br />

machining group with a strong reputation for delivering complex,<br />

difficult-to-manufacture orthopaedic implants and instruments,<br />

including nearly every conceivable type of precision-machined hook,<br />

plate and screw, as well as a full range of orthopaedic surgical<br />

instruments. Wire EDM, CMM, 3-, 4- and 5-axis mills, 2- and 4-axis<br />

CNC Swiss-style & multi-axis lathes. FDA-registered.<br />

574-269-3430 (phone)<br />

574-269-3430 (fax)<br />

esatterley@hotmail.com<br />

www.satterleyassoc.com


Orthopaedic Implants, Spinal Products & Medical Devices<br />

SAGER precision technologies is a leading manufacturer of<br />

orthopaedic implants, spinal products and medical devices.<br />

From rapid prototyping thru full production, our management team and production staff<br />

are adept at applying their experience and expertise to finding solutions to your needs.<br />

With two facilities totaling 48,000 sq. ft., we offer single-source responsibility for<br />

producing components from raw material thru finished goods.<br />

Process Capabilities<br />

• Concurrent engineering with customer’s development team<br />

• Rapid Prototyping<br />

• Automated spherical lapping and polishing<br />

• Multi-Pallet horizontal milling<br />

• Ultraprecision machining in climate-controlled cell with CMM<br />

• Twin spindle turning<br />

• Class 100 and 1000 clean room inspection and packaging<br />

• Electromechanical assembly and testing<br />

• Laser marking, Titanium anodizing, Passivating, Electropolishing<br />

Systems and Services<br />

• Sager-managed inventory programs thru reacting to customer’s MRP, JIT, Kanban<br />

and EDI for “Dock to Stock” programs<br />

• Project management with concurrent engineering from development through<br />

production<br />

• Statistical Process Control<br />

• Autocad and Solidworks CAD/CAM interfaces for Engineering Services<br />

• Continuous improvement using Kaizen event analysis<br />

Player Profile<br />

Sager Precision<br />

Technologies, Inc.<br />

123 Moore Road<br />

Weymouth, MA 02189<br />

USA<br />

781-335-5300 (phone)<br />

781-340-0517 (fax)<br />

Web site<br />

www.sagerprecision.com<br />

Founded<br />

1984<br />

Contacts<br />

Brad Correia<br />

President<br />

Facility<br />

Manufacturing facilities in<br />

Weymouth and Plymouth, MA<br />

Staff<br />

110 employees<br />

Certification<br />

FDA-registered<br />

ISO 9001:2000; 13485:2003<br />

EN46001<br />

BONEZone • Winter 2005 69


SC-ST<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

15 Woodworker’s Way<br />

Seabrook, NH 03874<br />

USA<br />

70 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

Schutte TGM, LLC MM MN MT<br />

4055 Morrill Road<br />

Jackson, MI 49201<br />

USA<br />

SCT, Inc. MN<br />

509 Commerce Street<br />

Franklin Lakes, NJ 07417<br />

USA<br />

Seabrook International, LLC CP LP MM MN MT PA SO SP ST<br />

Signal Orthopaedics / Xylon<br />

400 Pyramid Drive<br />

Marysville, MI 48040<br />

USA<br />

201-337-4212 (phone)<br />

201-337-3278 (fax)<br />

603-474-1919 (phone)<br />

603-474-1833 (fax)<br />

810-364-7070 (phone)<br />

810-364-7072 (fax)<br />

SIM Surgical MN<br />

1650 Headland Drive<br />

Fenton, MO 63026<br />

USA<br />

636-349-4960 (phone)<br />

800-521-2985 (toll free)<br />

636-326-2417 (fax)<br />

vozehc@sctinc.org<br />

pds@seabrookinternational.com<br />

www.seabrookinternational.com<br />

Signal Medical Corporation RM<br />

Slater Tools Inc. MT<br />

44725 Trinity Drive<br />

Clinton Township, MI 48038<br />

USA<br />

586-465-5000 (phone)<br />

586-465-3030 (fax)<br />

Southeastern Technology — Player MM MN<br />

905 Industrial Drive<br />

Murfreesboro, TN 37129<br />

USA<br />

615-890-1700 (phone)<br />

877-789-2500 (toll free)<br />

615-890-2914 (fax)<br />

TMorriello@SoutheasternTech.com<br />

www.southeasterntech.com<br />

300 Pump Road<br />

Lancaster, PA 17603<br />

USA<br />

717-392-8570 (phone)<br />

717-392-8578 (fax)<br />

sales@specializedmedical.com<br />

www.specializedmedical.com<br />

Orthopaedic Surgical Instruments & Implants. Our Program<br />

Managers serve as your key contact from concept through delivery.<br />

Our supply chain of strategic partners provides a variety of services<br />

in respective areas of expertise including engraving, coatings, welding,<br />

electrical components, water jet and CNC. FDA-registered.<br />

GMP compliant.<br />

Implants - Devices - Clean Room Packaging. Full service medical<br />

device contract manufacturing for 40 years. Custom design & prototype<br />

development. Trial runs or full-scale production. Comprehensive<br />

engineering/manufacturing support services. CNC screw machining,<br />

5-axis CNC milling, wire EDM, titanium anodization, laser marking,<br />

assembly & packaging in class 10,000 clean rooms. SMD is<br />

dedicated to meeting the most demanding specifications:<br />

ISO 13485:2003, FDA CGMP/QSR.<br />

signalmd@sbcglobal.net<br />

j.bartling@simsurgical.com<br />

www.simsurgical.com<br />

direct@slatertools.com<br />

www.slatertools.com<br />

Specialized Medical Devices, Inc. — Player MM MN PA SP YY<br />

Spire Biomedical ST<br />

One Patriots Park<br />

Bedford, MA 01730-2396<br />

USA<br />

781-275-6001 (phone)<br />

800-510-4815 (toll free)<br />

781-275-6010 (fax)<br />

biosales@spirecorp.com<br />

www.spirebiomedical.com<br />

Stahlwerk Ergste Westig GmbH RM<br />

Letmather Str. 69<br />

Schwerte, 58239<br />

Germany<br />

517-782-2938 (phone)<br />

517-782-2940 (fax)<br />

+49-2304-79-7259 (phone)<br />

+49-2304-79-482 (fax)<br />

davidtgm@acd.net<br />

www.schuttetgm.com<br />

medtech-vertrieb@zapp.com<br />

www.zapp.com


Implants - Devices - Clean Room Packaging<br />

Full Service Medical Device<br />

Contract Manufacturing<br />

With so much depending on the performance of<br />

your product, the need for absolute precision can be<br />

a life or death issue. That’s why, for over 40 years,<br />

orthopaedic and spinal companies have turned to<br />

Specialized Medical Devices for their most demanding<br />

medical devices and implants.<br />

SMD manufactures the most demanding Swiss Screw<br />

Machine products to within +/-.0001”.<br />

From prototype development to full production,<br />

SMD’s experienced engineers turn your design<br />

concepts into the finest quality medical products.<br />

From small run, individual components to full scale production and assembly, SMD is<br />

the first choice for Orthopaedic and Spinal companies. Because the pursuit of perfection--repeatable,<br />

consistent precision products--is an ongoing process. A process that<br />

SMD is committed to on every project. For one very important reason: Because you<br />

can’t afford anything less.<br />

• Contract Manufacturing<br />

• Clean Room assembly & packaging<br />

• Contract Packaging<br />

• 5-axis CNC Vertical Milling and Wire EDM<br />

• 10-axis CNC Screw Machining<br />

• Implants: connectors, hooks, plates, rods, screws<br />

• Devices: awls, anchor inserters, biopsy, drivers<br />

• Quickturn Prototyping<br />

Ultra precision CNC 5-asix vertical milling and CNC 10axis<br />

screw machining of complete implant systems as<br />

well as complementary disposable and reusable instruments.<br />

Specializing in titanium, stainless steel, cobalt chrome<br />

and PEEK as well as exotic metals.<br />

Turnkey finishing services include titanium anodization,<br />

laser marking, vacuum heat treating, passivation, electropolishing<br />

and bead blasting. Dimensional tolerances<br />

to within +/-.0001.<br />

Dedicated to meeting the most demanding specifications: using a product realization<br />

process based quality management system certified to ISO 13485:2003, Directive 93/42<br />

EEC and maintaining compliance with the FDA CGMP/QSR with capabilities for AQL<br />

sampling and SPC.<br />

Small Business, Woman Owned, Non-union Shop<br />

Dock-to-Stock and JIT Delivery Capabilities<br />

Player Profile<br />

Specialized Medical Devices, Inc.<br />

300 Pump Road<br />

Lancaster, PA 17603<br />

USA<br />

717-392-8570 (phone)<br />

717-392-8578 (fax)<br />

sales@specializedmedical.com<br />

Web site<br />

www.specializedmedical.com<br />

Founded<br />

1962<br />

Contacts<br />

Jack F. Fulton<br />

VP, Sales & Marketing<br />

JackF@specializedmedical.com<br />

Facility<br />

48,000 sq. ft.<br />

Staff<br />

130 employees<br />

Certification<br />

FDA-registered<br />

ISO 13485 certified<br />

Materials<br />

Titanium<br />

Stainless Steel<br />

Cobalt Chrome<br />

PEEK<br />

BONEZone • Winter 2005 71


ST-SY<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

370 Summit Point Drive<br />

Henrietta, New York 14467<br />

USA<br />

72 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

Stealth Medical Technologies, LLC — Player FO MM MN ST<br />

1489 Cedar Street<br />

Holt, MI 48842<br />

USA<br />

517-694-2300 (phone)<br />

517-694-2340 (fax)<br />

info@stealth-medical.com<br />

www.stealth-medical.com<br />

2975 South Horseshoe Drive<br />

Naples, FL 34104<br />

USA<br />

509 South 22nd Avenue<br />

Suite 508<br />

Bozeman, MT 59718<br />

USA<br />

239-643-6577 (phone)<br />

888-446-6862 (toll free)<br />

239-643-6530 (fax)<br />

STS duoTEK, Inc. AT PA YY<br />

585-321-5000 (phone)<br />

585-321-3058 (fax)<br />

406-556-3270 (phone)<br />

406-556-1322 (fax)<br />

trubino63@yahoo.com<br />

www.structuremedical.com<br />

gwhitbourne@stsduotek.com<br />

www.stsduotek.com<br />

Summit Corporate Services, Inc. YY<br />

damon@summitcorporate.com<br />

www.summitcorporate.com<br />

Supra Alloys, Inc. RM<br />

351 Cortez Circle<br />

Camarillo, CA 93012<br />

USA<br />

805-388-2138 (phone)<br />

800-647-8772 (toll free)<br />

805-987-6492 (fax)<br />

craig@supraalloys.com<br />

www.supraalloys.com<br />

Symmetry Design & Development Center (DDC) AT CA DS FO MM MN PA YY<br />

2094 Boeing Drive<br />

Warsaw, IN 46582<br />

USA<br />

574-267-8700 (phone)<br />

574-267-6618 (fax)<br />

info@symmetrymedical.com<br />

www.symmetrymedical.com<br />

Symmetry Jet FO MM MN SP ST<br />

5212 Aurelius Road<br />

Lansing, MI 48911<br />

USA<br />

517-882-4311 (phone)<br />

517-882-2330 (fax)<br />

info@symmetrymedical.com<br />

www.symmetrymedical.com<br />

Symmetry Medical Cheltenham Ltd. AT DS MM MN PA SP ST<br />

Unit 1, Malvern View Business Park<br />

Stella Way, Bishops Cleeve<br />

Gloucestershire, GL52 7DQ<br />

UK<br />

486 West 350 North<br />

Warsaw, IN 46582<br />

USA<br />

+44-1242-662-040 (phone)<br />

+44-1242-678-324 (fax)<br />

574-267-8700 (phone)<br />

574-267-7306 (fax)<br />

info@symmetrymedical.com<br />

www.symmetrymedical.com<br />

Symmetry Medical Inc. — Player AT CA DS FO MM MN PA SP ST YY<br />

220 West Market Street<br />

Warsaw, IN 46580<br />

USA<br />

574-268-2252 (phone)<br />

574-267-4551 (fax)<br />

tammyal@symmetrymedical.com<br />

www.symmetrymedical.com<br />

info@symmetrymedical.com<br />

www.symmetrymedical.com<br />

Symmetry PolyVac AT DS LP MM MN SP ST<br />

253 Abby Road<br />

Manchester, NH 03103<br />

USA<br />

Forging, Machining, Coating & Polishing. World leader in the forging,<br />

machining, coating and polishing of exotic metal alloys for the<br />

orthopaedic industry. We are prepared to meet your needs with<br />

total in-house processing from concept to final production. When<br />

you combine the highest quality with maximum savings, you have<br />

the Stealth Advantage. We are committed to complete customer<br />

satisfaction in everything we do. ISO 9001:2000.<br />

Structure Medical, Inc. CP MM<br />

Instruments, Implants Cases and Total Solutions® <strong>Supplier</strong>. <strong>The</strong><br />

world now has one source for instruments, cases and implants.<br />

With nine strategically located facilities throughout the U.S. and<br />

Europe, we provide unparalleled service to the medical device<br />

industry worldwide. With Symmetry DDC, Symmetry Jet, Symmetry<br />

Othy, Symmetry PolyVac, Symmetry Thornton (TPC) and Symmetry<br />

UltreXX, we are your one source for Total Solutions.® ISO<br />

13485:2003, FDA Registered, ISO 9001:2000, EN 46002:1997, EN<br />

46001, CE Marking, Environmental ISO 14001:1996/2004.<br />

Symmetry Othy AT DS LP MM MN PA SP ST<br />

603-647-7822 (phone)<br />

603-647-7877 (fax)<br />

info@symmetrymedical.com<br />

www.symmetrymedical.com


Symmetry Medical Is Your One Source for Total Solutions®<br />

<strong>The</strong> world now has one source for instruments, cases and implants —Symmetry Medical.<br />

We are a global market leader, offering trusted brands, Jet®, Othy®, PolyVac®, Thornton<br />

(TPC) and UltreXX®. With Symmetry Medical you get over 200 years of combined<br />

experience.<br />

With 13 strategically located facilities throughout the United States and Europe, we<br />

provide unparalleled service to the medical device industry worldwide. Our global<br />

representation gives you local, personalized service.<br />

Our products and services extend into over 25 medical device markets, such as<br />

orthopedic, spinal, trauma, dental, cardiovascular, ophthalmology, etc.<br />

Our unique position as a single source supplier helps you get new products to market<br />

faster. We provide comprehensive services, including complete systems ready for use.<br />

We go beyond the ordinary to include kitting, inventory management, co-development<br />

and more.<br />

Symmetry Medical Inc. is Symmetry DDC, Symmetry Jet, Symmetry Othy, Symmetry PolyVac, Symmetry Thornton<br />

(TPC) and Symmetry UltreXX.<br />

Symmetry Design & Development Center (DDC) opened January 2004. DDC offers Design Services/Co-development,<br />

Prototypes, Project Management, Total Solutions® and Symmetry Products.<br />

Symmetry Jet, located in Lansing, MI, specializes in precision forging, machining and full finishing for the<br />

orthopedic industry.<br />

Symmetry Othy, formed in Indiana in 1976, is a world leading supplier of custom and standard surgical<br />

instruments.<br />

Symmetry Medical Cheltenham (formerly Symmetry Othy UK) was founded in February 1977 in Cheltenham,<br />

England. It became part of Symmetry Medical Inc. in 1998, supplying instruments to the European medical<br />

community.<br />

Symmetry PolyVac USA, formed in Manchester, New Hampshire in 1983, is a world leading provider of metal,<br />

plastic and hybrid cases. PolyVac became a part of the group as a subsidiary of Symmetry Medical Inc. in July<br />

1996.<br />

Symmetry PolyVac France (formerly EuroSter SA) was acquired by Symmetry Medical Inc. in August 1999 as a<br />

distributor of plastic surgical instrument cases and trays. PolyVac, located in Lille, France, is a design and manufacturing<br />

facility for cases and trays.<br />

Symmetry Thornton (TPC) was founded in 1895 in Sheffield, England. Symmetry Thornton (TPC) specializes in<br />

precision forging, casting, rapid prototyping, machining and full finishing for orthopedic implants.<br />

Symmetry UltreXX was founded in 1988 in Avilla, Indiana. It is a world leading supplier of precision spinal and<br />

trauma instruments and implants.<br />

Symmetry Medical is your one source for<br />

Total Solutions®.<br />

Player Profile<br />

Symmetry Medical Inc.<br />

220 West Market Street<br />

Warsaw, Indiana 46580<br />

USA<br />

574-268-2252 (phone)<br />

574-267-4551 (fax)<br />

Web site<br />

www.symmetrymedical.com<br />

Founded<br />

Thornton (TPC) - 1895<br />

Othy Instruments - 1976<br />

Othy UK - 1977<br />

PolyVac Cases - 1983<br />

Jet - 1985<br />

UltreXX - 1988<br />

PolyVac France - 1999<br />

Design & Development Center<br />

(DDC) - 2004<br />

Contacts<br />

Andrew J. Miclot<br />

Senior Vice President<br />

Marketing, Sales, Business<br />

Development & Investor<br />

Relations Officer<br />

Facilities<br />

553,700 sq.ft. worldwide<br />

Staff<br />

1,797 worldwide<br />

Certification<br />

ISO 13485:2003<br />

FDA Registered<br />

ISO 9001:2000<br />

EN 46002:1997<br />

EN 46001<br />

CE Marking<br />

Environmental ISO 14001:<br />

1996/2004<br />

Focus<br />

Custom and standard surgical<br />

instruments<br />

Custom and standard cases<br />

Design & Development Centers<br />

Implant components<br />

Complete sets<br />

BONEZone • Winter 2005 73


SY-TH<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

2663 South Freeman Road<br />

PO Box 338<br />

Monticello, IN 47960<br />

USA<br />

574-583-3868 (phone)<br />

574-583-9250 (fax)<br />

tools@ffni.com<br />

www.cutting-tools.com<br />

Wilmington Facility<br />

115 Eames Street<br />

Wilmington, MA 01887-3379<br />

USA<br />

978-642-2400 (phone)<br />

978-658-4334 (fax)<br />

tecomet.sales@viasyshc.com<br />

www.viasyshealthcare.com<br />

11230 Deerfield Road<br />

Cincinnati, OH 45242<br />

USA<br />

74 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

Symmetry PolyVac France AT DS MM MN SP ST<br />

Zl de la Pilaterie, 14,<br />

Rue de la Ladrie, BP 165<br />

59653 Villeneuve d’Ascq<br />

Cedex<br />

France<br />

Beulah Road<br />

Sheffield S6 2AN<br />

UK<br />

200 Progress Way West<br />

Avilla, IN 46710<br />

USA<br />

28181 River Drive<br />

Circleville, OH 43113<br />

USA<br />

1100 Nola Avenue<br />

Barberton, OH 44203<br />

USA<br />

Manufacture, Sharpening & Reconditioning of Cutting Tools. Hand<br />

grinding, polishing and inspection. We’ll ship your custom burrs and<br />

cutting tools within seven to ten days of receipt of order. Although<br />

most orders are processed on an as-needed basis, we maintain a<br />

select inventory for JIT needs. S.S. twist drills & reamers manufactured<br />

to your specs. Burrs for aluminum, other non-ferrous metals,<br />

std. carbide, routers for fiberglass. FDA-registered.<br />

Tecomet, a subsidiary of VIASYS Healthcare — Player FO LP MM MN MT SP ST<br />

Extreme Performance in Orthopedics. Tecomet is an innovative<br />

manufacturing partner with the capacity and flexibility to perform<br />

under extreme conditions. We bend over backwards to provide engineered<br />

solutions, reduced time-to-market and contain costs. State<br />

of the art technologies, innovative, on-demand manufacturing and<br />

flexible management has made Tecomet a leader for more than 30<br />

years. FDA-registered, ISO 9001:2000.<br />

Teleflex Aerospace Manufacturing Group — Ohio FO MN<br />

<strong>The</strong>ken Orthopaedic AT<br />

+33-3-28-09-94-54 (phone)<br />

+33-3-20-72-31-04 (fax)<br />

Symmetry Thornton (TPC) CA FO MM MN ST<br />

+44-114-285-5881 (phone)<br />

+44-114-233-6978 (fax)<br />

260-897-2117 (phone)<br />

260-897-3884 (fax)<br />

513-489-9800 (phone)<br />

513-489-2409 (fax)<br />

740-477-5000 (phone)<br />

800-654-5696 (toll free)<br />

740-477-5001 (fax)<br />

330-753-9923 (phone)<br />

330-753-9925 (fax)<br />

info@symmetrymedical.com<br />

www.symmetrymedical.com<br />

Symmetry UltreXX MM MN SP ST<br />

T & L Sharpening, Inc. — Player MN<br />

Teleflex Medical OEM — Player MM MN<br />

2345 Waukegan Road<br />

Suite 120<br />

Bannockburn, IL 60015<br />

USA<br />

847-572-8000 (phone)<br />

847-572-8001 (fax)<br />

www.teleflexmedicaloem.com<br />

Developer and Manufacturer of Orthopedic Instruments and<br />

Devices A preeminent global outsource provider focused on orthopedic<br />

instruments and medical devices, including sutures. From<br />

concept development to manufacturing solutions, we provide dedicated<br />

engineering and technical services to ensure the successful<br />

transition from concept through development, manufacturing, and<br />

product packaging. Our brands include KMedic and Beere.<br />

FDA-registered, ISO 13485.<br />

info@symmetrymedical.com<br />

www.symmetrymedical.com<br />

info@symmetrymedical.com<br />

www.symmetrymedical.com<br />

contactus@teleflexaerospace.com<br />

www.teleflexaerospace.com<br />

Telesis Technologies, Inc. LP MT SP ST<br />

donovan@telesis.com<br />

www.telesis.com<br />

rtheken@thekensurgical.com<br />

www.thekensurgical.com


Leading <strong>Supplier</strong> of Orthopaedic Implants<br />

<strong>The</strong> ability to provide engineered solutions, manage<br />

cost containment and reduce product launch time<br />

through concurrent engineering has made Tecomet a<br />

leading supplier of orthopedic implants. Tecomet has<br />

the capacity and expertise OEMs require to deliver complex<br />

products with the highest quality. With innovative<br />

manufacturing and flexible management, Tecomet has<br />

earned a reputation for its ability to perform under<br />

extreme conditions.<br />

Extreme Manufacturing<br />

Tecomet specializes in reconstructive, trauma, spinal<br />

implants and cranio maxillofacial mesh. Tecomet offers<br />

cost-effective, on-demand cell manufacturing for flexibility<br />

and cost containment.<br />

Hip Systems As the manufacturer of the first near net shape forged hip stem, Tecomet<br />

has a long history in forging technology and has continued to improve its expertise in<br />

forged Cobalt Chrome, Titanium and Stainless Steel hip systems.<br />

Plate Systems From forged and machined plates for long bone fracture fixation to intricate<br />

photo-etched mini-plates for hand, foot, cranio maxillofacial and joint revision,<br />

Tecomet is using the optimal process to produce high quality implants at the targeted<br />

cost.<br />

Cranio Maxillofacial Mesh Engineered photochemical etching provides the foundation for<br />

top quality titanium trauma and reconstruction implants. A virtually unlimited range of<br />

designs, patterns and thicknesses allow applications specific to cranial and maxillofacial<br />

surgery, otolaryngology, neurology, plastic surgery and orthopedics.<br />

Extreme Technology<br />

Tecomet offers unique, proprietary technologies–in forging, machining and photochemical<br />

etching–to help OEMs and surgeons design new products. Engineers may take<br />

advantage of patented technologies to integrate new features, or to develop innovative<br />

products that are truly one-of-a-kind.<br />

Extreme Speed<br />

In 2005, Tecomet introduced LaunchQuick a dedicated, state-of-the-art, Process<br />

Development Center. LaunchQuick provides the collaborative environment surgeons<br />

and OEMs need to spawn new ideas. With the latest equipment and most sophisticated<br />

technologies at their fingertips, customers work side by side with the manufacturing<br />

experts at Tecomet to produce first article, pre-series, and to solve the most difficult<br />

manufacturing challenges. LaunchQuick provides a seamless transition to full-scale,<br />

on-demand manufacturing, and greatly reduces lead times for critical programs.<br />

Player Profile<br />

TECOMET<br />

Wilmington facility<br />

115 Eames Street<br />

Wilmington, MA 01887-3379<br />

USA<br />

978-642-2400 (phone)<br />

978-658-4334 (fax)<br />

tecomet.sales@viasyshc.com<br />

LaunchQuick<br />

Process / Product<br />

Development Center<br />

Bob Lynch, Sr. Director R&D and<br />

Product Development<br />

978-642-2468 (phone)<br />

robert.lynch@viasyshc.com<br />

Web site<br />

www.tecomet.com<br />

Founded<br />

1964<br />

Contacts<br />

Pat O’Neill<br />

Director of Sales<br />

630-222-5780 (phone)<br />

pat.oneill@viasyshc.com<br />

Donna Baker<br />

Inside Sales Manager<br />

781-782-6440 (phone)<br />

donna.baker@viasyshc.com<br />

Alice Higdon<br />

South Central/South East<br />

901-233-6396 (phone)<br />

alice.higdon@viasyshc.com<br />

Geoff Krakora<br />

West Coast<br />

480-239-1864 (phone)<br />

geoff.krakora@viasyshc.com<br />

Facility<br />

100,000 sq. ft.<br />

Staff<br />

170 employees<br />

Certification<br />

FDA-registered<br />

ISO 9001:2000<br />

Background<br />

Tecomet is a subsidiary of VIASYS<br />

Healthcare Inc. (NYSE: VAS), a world-class<br />

medical technology company dedicated to<br />

improving the quality of human life. With<br />

more than 2,000 employees worldwide,<br />

VIASYS is committed to delivering the<br />

highest quality products and services to<br />

the medical community.<br />

BONEZone • Winter 2005 75


TH-UN<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

181 East Halsey Road<br />

Parsippany, NJ 07054<br />

USA<br />

973-428-1900 (phone)<br />

888-482-6486 (toll free)<br />

973-428-7250 (fax)<br />

rraess@titanium.com<br />

www.titanium.com<br />

116 Pleasant Avenue<br />

Upper Saddle River, NJ 07458<br />

USA<br />

201-825-1212 x 530 (phone)<br />

201-236-9814 (fax)<br />

dstrohmeyer@trianglemfg.com<br />

www.trianglemfg.com<br />

Highland Industrial Park<br />

601 Park East Drive<br />

Woonsocket, RI 02895<br />

USA<br />

76 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

Thortex, Inc. MM MN ST<br />

15045 NE Mason Street<br />

Portland, OR 97230<br />

USA<br />

Ticona-U.S. RM<br />

8501 North Loop East<br />

Houston, TX 77029<br />

USA<br />

Titanium Industries, Inc. — Player RM<br />

12428 State Route 88<br />

PO Box 287<br />

Garrettsville, OH 44231<br />

USA<br />

Titanium Mill Products. Titanium Industries is the premier distributor<br />

of titanium mill products used for surgical implant applications in<br />

the medical industry. Throughout our titanium service center network<br />

across the U.S. and Canada, we stock the most extensive<br />

inventory of ASTM specifications of titanium bar, billet, plate, sheet<br />

and wire products. ISO 9001:2000 and AS9100A certified.<br />

Tornos Technologies MM MN MT<br />

70 Pocono Road<br />

PO Box 325<br />

Brookfield, CT 06804<br />

USA<br />

203-775-4319 (phone)<br />

203-775-4281 (fax)<br />

Triangle Manufacturing Co., Inc. — Player MM MN RM<br />

Design, Manufacturing, Speed to Market. For more than 50 years,<br />

Triangle Manufacturing has been a customer-focused, value-added<br />

engineering/manufacturing partner to some of the largest, most<br />

advanced medical companies in the world. With emphasis on the<br />

highest quality standards as well as on-time delivery, Triangle provides<br />

lean manufacturing solutions to the medical industry.<br />

FDA-registered, ISO 9001:2000 certified.<br />

Troy Innovative Instruments, Inc. MM MN<br />

330-527-9567 (phone)<br />

330-527-3299 (fax)<br />

401-762-4100 (phone)<br />

401-762-4262 (fax)<br />

contact@tornosusa.com<br />

www.tornos.ch<br />

tii@nacs.net<br />

www.orthosupplier.com/profiles/<br />

troy-innovative-instruments2.htm<br />

Tytex Inc. USA RM<br />

80 Shelton Technology Center<br />

Shelton, CT 06484-0105<br />

USA<br />

gwerman@tytex.com<br />

www.tytex.com<br />

Unique Design AT YY<br />

Unique Instruments, Inc. — Player MM MN PA SP ST<br />

6688 Dixie Highway<br />

Bridgeport, MI 48722<br />

USA<br />

989-746-0780 (phone)<br />

989-746-9004 (fax)<br />

sales@uniqueinstruments.com<br />

www.uniqueinstruments.com<br />

503-654-5726 (phone)<br />

503-654-9711 (fax)<br />

713-671-0097 x305 (phone)<br />

800-242-8469 x305 (toll free)<br />

713-671-0306 (fax)<br />

203-922-0105 (phone)<br />

203-922-0130 (fax)<br />

Surgical Cutting Accessories, Instruments & Implants. Total supply<br />

chain solution, from engineering & prototyping through production<br />

& packaging. Extensive experience supporting new product launches<br />

to reduce your time to market. Sterile packaging & stocking programs<br />

to reduce your inventory investment. Laser etching, TiN coating,<br />

color coding, electropolishing. Drills, taps, reamers, burs,<br />

blades, instruments, implants. FDA-registered, ISO 9001:2000,<br />

ISO 13485:2003.<br />

dwalker@thortexinc.com<br />

www.orthosupplier.com/<br />

profiles/thortex2.htm<br />

harvey.stein@ticona.com<br />

www.ticona.com<br />

info@uniqueD.com<br />

www.uniqueD.com


Surgical Cutting Accessories, Instruments & Implants<br />

Quality — Over 25 years of superior craftsmanship in producing the finest surgical cutting accessories,<br />

instruments and implants. It is a quality difference skilled surgeons can feel.<br />

Supply Chain Solutions — We will work with you to develop stocking programs that improve customer<br />

service levels and reduce your inventory investment.<br />

Information Technology — Integrated enterprise system, quality system and finite capacity scheduling<br />

have transformed our ability to provide exceptional on-time performance in meeting your leadtime<br />

requirements.<br />

Full-Service Capabilities<br />

Dedicated Prototype Cell — Dedicated machinery and personnel with capabilities identical to our<br />

production cells provide rapid turn-around prototypes and smooth production scale-up.<br />

Custom Packaging & Labeling — Complete sterile and non-sterile packaging and labeling<br />

capabilities.<br />

Engineering Support — From prototype through production, our engineers can assist you with<br />

material selection, product performance enhancement and design support for manufacturability.<br />

Specialized Processes —<br />

• Color Code Identification of Cutting Accessories<br />

• Electron Beam Welding, Laser Welding, Induction Welding and Brazing<br />

• Chemical and Laser Etching<br />

• Titanium Nitride Coating, Ion Nitride Coating, Anodizing, Diamond Coating<br />

• Electro-Polishing, Micro De-burring<br />

• Laser Cutting, Gundrilling, Multi-Axis Cutter Grinding<br />

Complete Range of Products<br />

Surgical Drill Bits And Reamers — Cannulated drills and reamers, dental implant cutters, step drills<br />

and reamers are produced for orthopaedic, maxillo-facial, cranial/neuro and ENT procedures.<br />

Surgical Cutting Burs — Fluted and diamond coated burs for otology, podiatry, arthroscopy, neuro,<br />

maxillo-facial and other surgical specialties.<br />

Surgical Blades — Extensive array of blades used in total knee procedures, arthroscopy applications<br />

involving ACL reconstruction, podiatry and other specialties.<br />

Surgical Instruments — Multi-component instrument assemblies and handles utilizing lightweight<br />

alloys.<br />

Implants — Precision-machined spinal and orthopaedic implants utilizing stainless steel and titanium.<br />

We have extensive experience in producing fracture fixation plates and spinal screw, hook<br />

and rod systems.<br />

Player Profile<br />

UNIQUE Instruments, Inc.<br />

6688 Dixie Highway<br />

Bridgeport, MI 48722<br />

USA<br />

989-746-0780 (phone)<br />

989-746-9004 (fax)<br />

sales@uniqueinstruments.com<br />

Web site<br />

www.uniqueinstruments.com<br />

Founded<br />

1977<br />

Contacts<br />

Mark Burba<br />

Chief Operating Officer<br />

Mike Lushin<br />

Engineering & Sales Manager<br />

Facility<br />

70,000 sq. ft.<br />

Staff<br />

300 employees<br />

Certification<br />

FDA-registered<br />

ISO 9001:2000<br />

ISO 13485:2003<br />

Focus<br />

• surgical cutting accessories<br />

• surgical instruments<br />

• implants<br />

BONEZone • Winter 2005 77


UN-ZA<br />

AT<br />

analysis/testing<br />

CA<br />

casting<br />

CP<br />

component parts<br />

DS<br />

delivery systems<br />

FO<br />

forging<br />

LP<br />

laser processing<br />

MM<br />

implant mfg.<br />

MN<br />

instrument mfg.<br />

MR<br />

manufacturer reps.<br />

MT<br />

machinery/tooling<br />

PA<br />

packaging/<br />

sterilization<br />

RM<br />

raw materials<br />

SO<br />

software<br />

solutions<br />

SP<br />

surface preparation<br />

ST<br />

surface treatments<br />

YY<br />

consultants<br />

3045 Commercial Avenue<br />

Northbrook, IL 60062-1997<br />

USA<br />

847-498-3111 (phone)<br />

888-326-7556 (outside Illinois)<br />

(toll free)<br />

847-498-2810 (fax)<br />

dyoho@vulcanium.com<br />

www.vulcanium.com<br />

West Lenni Road<br />

PO Box 127<br />

Lenni, PA 19052<br />

USA<br />

610-459-1000 (phone)<br />

800-999-1700 (toll free)<br />

610-459-1084 (fax)<br />

westlakeplastics@westlakeplastics.com<br />

www.westlakeplastics.com<br />

Unit 12 Parkway Close<br />

Parkway Industrial Estate<br />

Sheffield, S9 4WJ<br />

UK<br />

78 BONEZone • Winter 2005<br />

BoneZone <strong>2006</strong> <strong>Supplier</strong> <strong>Directory</strong><br />

United Orthopedic Corporation MM MN<br />

14F-2 No. 268 Lian Cheng Road<br />

Chung Ho. City<br />

Taipei 235<br />

Taiwan<br />

619 Oak Street<br />

PO. Box 1529<br />

Oak Harbor, WA 98277<br />

USA<br />

886-2822-73996 (phone)<br />

886-2822-73997 (fax)<br />

Upchurch Medical ttrt MM MN<br />

360-679-8718 (phone)<br />

800-372-6042 (toll free)<br />

800-359-3460 (fax)<br />

Vulcanium Metals Incorporated — Player RM<br />

<strong>The</strong> Best in Titanium. We are a global leader in the distribution of<br />

titanium mill products, stocking metal for implantation, instrumentation<br />

and other medical applications for quick delivery worldwide.<br />

Sheet, plate, bar and billet to ASTM medical implant specifications<br />

are immediately available with complete documentation and melt<br />

source traceability. Value-added services available. VMI is<br />

ISO 9001:2000 certified.<br />

Westlake Plastics Company — Player RM<br />

<strong>The</strong> First Name in Plastics for Orthopaedics. Manufacturer of<br />

extruded and compression molded high performance thermoplastics<br />

for the orthopaedic marketplace. All stock medical products at<br />

Westlake Plastics are typically USP Class VI approved base resins,<br />

lot controlled and traceable & stress relieved. We supply the major<br />

plastics products used in three major product categories: containers,<br />

instruments and implant systems.<br />

Zapp (GB) Ltd. RM<br />

44-0114-278-8822 (phone)<br />

44-0114-278-8833 (fax)<br />

jasonlin@uoc.com.tw<br />

www.uoc.com.tw<br />

rlowell@idexcorp.com<br />

www.upchurchmedical.com<br />

david.hardacre@zapp.com<br />

www.zapp.com<br />

Strategic Sourcing for the Orthopaedic Industry<br />

Visit the <strong>Supplier</strong> <strong>Directory</strong> online at<br />

www.orthosupplier.com


Orthopedic Surgical Instruments & Access, Procedural and Closure Devices<br />

Your Total OEM Resource for Surgical Instruments, Medical Devices,<br />

Components, and Contract Manufacturing Services<br />

Teleflex Medical OEM products and services encompass the Beere Medical®, KMedic®, Deknatel®, and TFX OEM<br />

brands. <strong>The</strong> teams serving these brands provide dedicated engineering and technical service to ensure the successful<br />

transition of your product as it evolves from concept through development, manufacturing, and product<br />

packaging. Teleflex Medical OEM’s manufacturing facilities comply appropriately to:<br />

• 9001: 2000 ISO<br />

• 13485: 2003 ISO<br />

• FDA Registered Medical Device Manufacturer<br />

• CFR 21 Part 820 cGMP Compliant<br />

• Delivers to customer-defined quality requirements<br />

OEM Orthopedics - Beere Medical and KMedic, leading global suppliers of orthopedic and spinal surgical instruments,<br />

together provide a single source for your instrument needs. Beere, known for its innovation and precision<br />

machined instruments and ergonomic silicon handles and KMedic, a leader in handcrafted forged instruments,<br />

have a total offering of more than 5,000 high quality surgical instruments.<br />

Beere’s offering is heavily focused on:<br />

• Ergonomic Ortho-Grip® silicone rubber handles<br />

• Ratcheting screwdrivers<br />

• Torque limiting instruments<br />

• Spinal implant removal kit<br />

KMedic’s broad product offering encompasses instruments for surgical procedures including:<br />

• General Orthopedic<br />

• Spine<br />

• Trauma<br />

• Reconstructive<br />

• Arthroscopic<br />

OEM Access, Procedural, and Closure Devices - Deknatel provides a full line of high quality absorbable/nonabsorbable<br />

surgical suture materials including Force Fiber® to the world’s largest medical device companies.<br />

Materials are extruded, braided, dyed, and coated in tightly controlled environments to achieve exact customer<br />

specifications ranging from spools to fully assembled devices including needle attachment. Specifically:<br />

Medical Grade Sutures, Fibers and Resins<br />

• Absorbable & Non-Absorbable<br />

• Braided or Twisted<br />

• Extruded<br />

• Contract, Private Label, Packaging, and Sterilization Services<br />

TFX OEM offers a wide array of medical devices, high-precision extrusions, and guidewires for access and diagnostic<br />

procedures. Our extensive experience and knowledge of materials has enabled us to overcome complex<br />

manufacturing challenges associated with heat shrinkable and precision extrusions incorporating tight tolerances,<br />

ultra thin walls, and multiple lumens. Our finishing expertise includes laser microdrilling, tip forming and micromolding.<br />

TFX OEM manufactures a broad array of delivery systems (listed below) with moveable core and Jformed<br />

distal ends. Specifically:<br />

Extrustions/Catheter Fabrication<br />

• PTFE, FEP, PFA, ETFE, & PVDF Extrusion<br />

• Polyethylenes<br />

• Polypropylenes, Polycarbonate<br />

• Profile Extrusion<br />

• Step Grinding & Centerless Grinding<br />

• Finishing for Flaring, Tipping Drilling, and Hub Molding<br />

• Tube Testing Capabilities<br />

• Prototype Compounding Capabilities<br />

Guidewires<br />

• PTFE Precoated<br />

• Access & Interventional<br />

• Specialty Wires<br />

• Private Label Sterile<br />

Custom Devices<br />

• Peelable Introducers<br />

• OTN Introducers<br />

• Introducer Kits<br />

• Epidural Catheters<br />

• Microcatheters<br />

• Assembly, Packaging and Sterilization<br />

• Multilumen Catheters<br />

• Multi-durometer braided catheter<br />

Player Profile<br />

Teleflex Medical OEM<br />

Representing Beere, KMedic, Deknatel and<br />

TFX OEM<br />

2345 Waukegan Road, Suite 120<br />

Bannockburn, IL 60015<br />

USA<br />

847-572-8000 (phone)<br />

847-572-8001 (fax)<br />

Web site<br />

www.teleflexmedicaloem.com<br />

Contacts<br />

Beere Medical OEM<br />

5307 95th Avenue<br />

Kenosha, WI 53144<br />

262-657-2800 (phone)<br />

800-295-8505 (toll-free)<br />

262-657-2801 (fax)<br />

info@beeremedical.com<br />

KMedic OEM<br />

5307 95th Avenue<br />

Kenosha, WI 53144<br />

262-657-2800 (phone)<br />

800-295-8505 (toll-free)<br />

262-657-2801 (fax)<br />

oeminfo@kmedic.com<br />

TFX OEM<br />

50 Plantation Drive<br />

Jaffrey NH 03452<br />

603-532-7706 (phone)<br />

800-548-6600 (toll-free)<br />

603-532-6108 (fax)<br />

tfxsales@teleflexmedical.com<br />

Deknatel OEM<br />

375 Forbes Boulevard<br />

Mansfield, MA 02048-1805<br />

508-964-6021 (phone)<br />

800-458-2553 (toll-free)<br />

508-964-6078 (fax)<br />

sfillion@teleflexmedical.com<br />

Founded<br />

1943 - Teleflex Incorporated<br />

Certification<br />

FDA-registered<br />

ISO 13485<br />

Focus<br />

Orthopedic, trauma and spinal surgical<br />

instruments and access, procedural and<br />

closure devices.<br />

Innovative, High Quality Products - As a<br />

preeminent outsource provider, Teleflex<br />

Medical OEM has the market vision, corporate<br />

strength and global presence to be<br />

your long-term business partner. From<br />

concept development to our manufacturing<br />

solutions or even complete privatelabel<br />

procedure kits, Teleflex Medical OEM<br />

provides medical device manufacturers<br />

with the widest range or solutions, and<br />

unsurpassed customer service.<br />

Perhaps that’s why, for more than 30<br />

years, medical device manufacturers<br />

around the world have turned to Teleflex<br />

Medical OEM. We have the ability, through<br />

our global presence, to support your<br />

worldwide operations.<br />

BONEZone • Winter 2005 79


Forging, Machining, Coating & Polishing<br />

Since our beginning in 1994, we have quickly established our reputation as a world leader in<br />

the near-net forging of exotic alloys for the orthopaedic implant industry.<br />

Our advanced technical capabilities and highly skilled workforce allow us to serve as a comprehensive,<br />

“one-stop” resource for our customers. We specialize in products made from titanium,<br />

cobalt-chromium-molybdenum and zirconium and offer complete design, forging,<br />

machining, polishing and porous coating services. By partnering with our customers at every<br />

step in the production process, we are able to provide cost-effective solutions to the toughest<br />

engineering problems and deliver quality products that meet or exceed design specifications.<br />

<strong>The</strong> quality management system at Stealth Medical Technologies is certified to the ISO<br />

9001:2000 American National Standard. In developing, maintaining and improving our quality<br />

systems, the requirements of our customers are the primary concern. We deliver products<br />

that are top-quality, structurally sound and dimensionally exact. Our Quality Statement says it<br />

best: “Complete customer satisfaction through responsibility, integrity and commitment to<br />

excellence in everything we do.”<br />

Expertise & Mastery — We’ve mastered the net and nearnet<br />

shape forging process of exotic alloys and have quickly<br />

become a leading supplier to the medical implant<br />

industry. With an experienced workforce, state of the art<br />

design technology and forging expertise, we offer top-ofthe-line<br />

products that are both customized and flawless.<br />

Unique & Customized — We specialize in the use of exotic<br />

alloys, including titanium, cobalt-chromium-molybdenum<br />

and zirconium. Our specially developed forging process<br />

results in precisely crafted products that are exceptionally strong and durable. This process<br />

allows us to manufacture your product to exact dimensional requirements with little or no<br />

machining, thus providing you with significant cost savings.<br />

Comprehensive, Knowledgeable & Customer Focused — Our entire operation has been<br />

designed to meet the needs of our customers, and our unique “one-stop” service allows us<br />

to offer an integrated plan that encompasses all aspects of design, quality control and production<br />

of your product.<br />

• 2-D AutoCAD and 3-D Unigraphics design services<br />

• Robotic radial forge<br />

• CNC controlled screw-type forging presses<br />

• CAM programming/CNC machining with horizontal/vertical mills<br />

• EDM precision die sinking<br />

• Quality lab includes automatic CMM/Non-Destructive Testing<br />

• Porous coating of implants using sintered titanium and cobalt<br />

Commitment to Quality — Achieving and maintaining ISO 9001:2000 certification demonstrates<br />

that STEALTH has developed and implemented effective quality systems throughout<br />

its production process, and that monitoring mechanisms are in place to ensure that requirements<br />

for quality are being maintained. When we release a product, it is high quality, structurally<br />

sound and dimensionally exact.<br />

Experience the Best — STEALTH has become the industry leader in the forging of exotic<br />

alloys for the orthopaedic implant industry. Our mission statement says it best — “Complete<br />

customer satisfaction through responsibility, integrity and commitment to excellence in<br />

everything we do.”<br />

Player Profile<br />

STEALTH Medical Technologies<br />

Corporate Headquarters<br />

1489 Cedar Street<br />

Holt, MI 48842<br />

USA<br />

517-694-2300 (phone)<br />

517-694-2340 (fax)<br />

Web site<br />

www.stealth-medical.com<br />

Founded<br />

1994<br />

Contacts<br />

Mike Miller<br />

Chief Executive Officer<br />

517-694-2300<br />

miller@stealth-medical.com<br />

Bill Frey<br />

C.O.O.<br />

517-694-2300<br />

frey@stealth-medical.com<br />

Joe Zuzula<br />

Sales, Marketing & Quality<br />

517-694-2300<br />

zuzula@stealth-medical.com<br />

Jeffrey Anto<br />

Director, Coating & Finishing Division<br />

901-853-7555<br />

anto@stealth-medical.com<br />

Facility<br />

Staff<br />

200 employees<br />

Certification<br />

ISO 9001:2000<br />

Focus<br />

orthopaedic implant industry<br />

Background<br />

“Since our company’s establishment<br />

in 1994, we have quickly built a<br />

strong reputation as a manufacturer<br />

of the highest quality, most structurally<br />

sound, customized specialty<br />

forgings available in the industry.<br />

This is a result of our undaunting<br />

commitment to provide a product<br />

that not only meets, but exceeds our<br />

customer’s stringent specifications<br />

and requirements.”<br />

Mike Miller<br />

Chief Executive Officer<br />

Stealth Medical Technologies<br />

BONEZone • Winter 2005 81


“MY CAREER PATHS AND OBJECTIVES HAVE<br />

EXPANDED CONSIDERABLY SINCE MY<br />

MEMBERSHIP BEGAN, AND<br />

CONTINUE TO GROW<br />

EXPONENTIALLY.<br />

THANK YOU!!!”<br />

- Member since 2000<br />

THE INSTITUTE FOR ORTHOPAEDICS<br />

BUSINESS INTELLIGENCE NETWORK<br />

(http://www.orthoworld.com/member_benefits.php)<br />

email: knowledge@orthoworld.com


THE INSTITUTE FOR ORTHOPAEDICS<br />

An international business intelligence network of industry professionals and<br />

entrepreneurs, designed to keep you abreast of the latest business developments<br />

and ahead of your competition, both inside and outside your company.<br />

Covers Reconstructive, Spine, Trauma, Arthroscopy/Sports Medicine<br />

Biologics and other market segments.<br />

Membership provides you the following<br />

Access to the private members area of www.orthoworld.com, which includes:<br />

Daily OrthoFlash - Real-time, strategic orthopaedic<br />

news flashes emailed directly to you and available with<br />

links to full text citations.<br />

<strong>The</strong> OrthoWorld Archives - <strong>The</strong> world’s largest database<br />

of strategic orthopaedic intelligence.<br />

Comprehensive directories of orthopaedic specific<br />

resources including:<br />

- 510(k)s, Patent Offices, M&A Activities, Databases/<br />

Libraries, etc.<br />

- Manufacturers, Products, <strong>Supplier</strong>s, Consultants,<br />

Distributors, Institute Members, Meetings, Societies, etc.<br />

- Members Discussion Forum<br />

Members also receive the following publications<br />

Bare Bones®:<br />

<strong>The</strong> premier monthly<br />

executive summary of key<br />

strategic orthopaedic events.<br />

OrthoKnow®:<br />

Monthly high-level<br />

strategic insights into the<br />

orthopaedic industry.<br />

<strong>The</strong> Worldwide Orthopaedic<br />

Market Overview:<br />

<strong>The</strong> annual summary of<br />

the global orthopaedic<br />

market that features:<br />

• Product sales by region<br />

and segment<br />

• Company sales overall and<br />

by segment<br />

• Strategic alliance activity<br />

• Product and company news<br />

• Emerging technologies in<br />

orthopaedics<br />

Executives, product managers, engineers, venture capitalists, distributors and sales reps<br />

all stay on top and out ahead by knowing the latest technologies, treatments, products<br />

and trends affecting the market.<br />

KNOWLEDGE ENTERPRISES, INC.<br />

<strong>The</strong> OrthoPeople<br />

147 Bell Street, Suite 303 Chagrin Falls OH 44022 USA<br />

440 247 9051 Fax 440 247 9053 www.orthoworld.com


11 Presidential Way<br />

Woburn, MA 01801<br />

Phone: 781.994.5000<br />

Fax: 781.994.5001<br />

info@bostoncenterless.com<br />

ISO 9001:2000 Certified<br />

Precision Grinding<br />

• BioDur ® 316LS stainless<br />

• BioDur ® 108 alloy<br />

• BioDur ® TrimRite ® stainless<br />

• Custom 455 ® stainless<br />

• Custom 465 ® stainless<br />

• Titanium alloys<br />

• Tolerances to .000050"<br />

• Finishes to 3Ra<br />

Straightness, roundness and size<br />

tolerance are essential to medical<br />

component manufacturing. At Boston<br />

Centerless, we understand your needs<br />

and provide materials precisely to<br />

specification each and every time,<br />

allowing your machining process to run<br />

smoothly. We have a state-of-the-art<br />

facility with an extensive inventory of<br />

medical alloys.<br />

BioDur, Custom 465, Custom 455 and TrimRite are<br />

registered trademarks of CRS Holdings, Inc.,<br />

a subsidiary of Carpenter Technology Corporation.<br />

800 -343-4111 • www.bostoncenterless.com


Introduction<br />

Mass finishing may conjure up an image of thousands of parts<br />

being dumped into a barrel, slopped with water and tumbled<br />

part-on-part, within some media to some specific end. This<br />

vision perhaps represents the best that technology had to offer<br />

many years ago. While this procedure is still acceptable in applications<br />

requiring only minimum levels of process control, today’s<br />

machinery has evolved to permit sophisticated batch processing<br />

with lot integrity, as well as a single part flow to minimize onhand<br />

stock.<br />

Whether the objective is reducing intraoperative glare, removing<br />

burrs on screws, minimizing tissue trauma or refining surface<br />

structure to eliminate microscopic recesses that can harbor infection,<br />

mass finishing processes meet a wide range of functional<br />

and cosmetic requirements and, compared to hand finishing,<br />

offer significant advantages in terms of simplicity and automation.<br />

Definition<br />

Mass finishing comprises a large number of processes including<br />

relatively low energy vibratory finishing (0.75 - 1.5 G); higher<br />

energy centrifugal disc finishing (5 - 7 G) or centrifugal barrel<br />

finishing (10 - 20 G); and spin, spindle and drag finishing<br />

(4 - 20 G).<br />

All of these methods are independent processes within the overall<br />

manufacturing cycle, and all are characterized by the interaction<br />

of a component with equipment, media and, in many cases, a<br />

chemical solution. In certain instances, dry finishing is used to<br />

eliminate the waste water generated by conventional mass finishing<br />

processes.<br />

<strong>The</strong>se basic components combine with parameters such as cycle<br />

time, amplitude, frequency or speed, lubricity, pH, etc. to finetune<br />

the process.<br />

Kyle Elmblad<br />

Technical Manager<br />

Hammond Roto-Finish<br />

Vibratory Finishing<br />

Vibratory finishing is a batch process whereby components are<br />

placed into a machine for a finite period of time and are then<br />

extracted. In some cases, a continuous flow of parts in and out of<br />

a machine is possible. For extremely delicate parts, vibratory<br />

machines equipped with urethane-lined dividers protect the<br />

components from damaging part-on-part contact.<br />

Vibratory finishing<br />

may be used to blend<br />

away machining lines<br />

left from the manufacturing<br />

process (See<br />

Figure 1.), or after<br />

robotically grinding<br />

and polishing<br />

ergonomic contours<br />

into a surgical instrument.<br />

As seen in<br />

Figure 2, a device may<br />

receive a dull finish to<br />

reduce surface glare.<br />

In this turnkey application,<br />

the finishing<br />

operation is cellular<br />

and encompasses<br />

robotic handling,<br />

mechanical finishing<br />

and feeding of the<br />

parts into a vibratory<br />

finishing unit.<br />

Centrifugal Disc Finishing<br />

Centrifugal disc finishing<br />

utilizes a spinning<br />

base in the bottom<br />

of the finishing<br />

unit to produce a torroidal<br />

flow of parts<br />

and media. (See<br />

Figure 3.) Centrifugal<br />

force moves parts to<br />

the outside wall,<br />

where the relative<br />

TECHNOLOGY<br />

Mass Finishing Processes—<br />

Not Just for Marbles Any More<br />

Figure 1.<br />

Vibratory finishing of a femoral component.<br />

Figure 2.<br />

Vibratory finishing of a surgical instrument.<br />

Figure 3. Centrifugal disc finisher.<br />

continued on page 86<br />

BONEZone • Winter 2005 85


TECHNOLOGY<br />

Mass Finishing Processes, continued from page 85<br />

motion between the parts and media, combined with compression<br />

at the surface of the outside wall, greatly increases the work<br />

accomplished.<br />

Centrifugal disc finishers are perhaps the most versatile type of<br />

machine used in the industry, due to a the higher energy level<br />

with greater ability for automation and reduced operational labor.<br />

<strong>The</strong>se machines finish the widest variety of components for the<br />

medical device industry. Bone screws, acetabular and femoral hip<br />

components, femoral knee components, clamps, cutters, drill bits<br />

and forceps all derive benefit from centrifugal disc finishing. (See<br />

Figures 4, 5, and 6.)<br />

Figure 4.<br />

Mass-finished knee components.<br />

Figure 5.<br />

Mass-finished hip components.<br />

Figure 6.<br />

A wide variety of mass-finished components.<br />

Centrifugal Barrel<br />

Finishing<br />

Centrifugal barrel<br />

machines resemble<br />

Ferris wheels, as seen<br />

in Figure 7. <strong>The</strong><br />

machine consists of<br />

a rotating turret<br />

with individual barrels<br />

mounted to its<br />

exterior. <strong>The</strong> barrels<br />

rotate in the direction<br />

opposite the<br />

turret, creating an<br />

action that applies a<br />

tremendous amount<br />

of compression<br />

between the media<br />

and the part during<br />

rotation.<br />

<strong>The</strong> extremely high<br />

energy associated<br />

with centrifugal barrel<br />

machining is<br />

especially beneficial<br />

when finishing difficult-to-process<br />

parts<br />

or those made of<br />

extremely hard alloy,<br />

and works equally<br />

well with fragile or<br />

delicate parts. <strong>The</strong><br />

process is laborintensive,<br />

but<br />

rewards the user<br />

with exceptional finishes<br />

that appear to<br />

be hand-buffed. In<br />

certain instances, compartmentalized barrels (or 1/2- or 1/3-size<br />

barrels) are used to process individual components where parton-part<br />

contact is undesirable.<br />

86 BONEZone • Winter 2005<br />

Spin, Spindle and<br />

Drag Finishing<br />

Spin, spindle and drag<br />

machines apply centrifugal<br />

force and subject a fixed part<br />

to a finishing media, as<br />

opposed to other applications<br />

in which parts move freely<br />

within the action of a media.<br />

In this process, the parts are<br />

fixtured and move through<br />

either a static or a counterrotating<br />

mass of media where<br />

tremendous amounts of energy<br />

are generated. (See Figure 8.)<br />

<strong>The</strong> major advantage to this<br />

finishing method is that a part,<br />

being fixtured, cannot possibly<br />

contact another part—thus<br />

eliminating the potential for<br />

part-on-part damage.<br />

Summary<br />

Whatever the medical device,<br />

a mass finishing process exists<br />

that may improve its function or appearance. Generally, the<br />

equipment and process are chosen to meet the specific needs of<br />

the part based on finish requirements, production and floor<br />

space. <strong>The</strong> mass finishing industry has outgrown its historic lowtech<br />

image and, with proper controls, mass finishing can be a<br />

robust and dependable part of the manufacturing process.<br />

<strong>The</strong> Hammond Roto-Finish Compound Group is ISO:9002 certified.<br />

<strong>The</strong> company manufactures such equipment as Vibratory Bowls,<br />

Tubs and Multi-Pass® machines for continuous processing;<br />

Centrifugal Disc Machines with the Up-Flow design; Steel,<br />

Ceramic, Plastic and a new Dry Media; Roto-Finish Roto-Brite®<br />

Compounds and Turn-Key systems including material handling,<br />

robots, vision and inspection equipment.<br />

Kyle Elmblad is the Technical Manager for Hammond Roto-Finish<br />

of Kalamazoo, Michigan. He is a degreed chemist with 23 years of<br />

experience in the Metal Finishing Industry and has published several<br />

articles for the industry. He can be reached at KElmblad@rotofinish.com.<br />

HAMMOND ROTO-FINISH<br />

1600 Douglas Avenue<br />

Kalamazoo, MI 49007<br />

USA<br />

269-345-7151 (phone)<br />

269-345-1710 (fax)<br />

www.roto-finish.com<br />

Figure 7.<br />

Centrifugal barrel finisher.<br />

Figure 8.<br />

Fixtured part moves through media.


Laminated electrical steel cores—those used for electric motors or<br />

other electromagnetic devices—have been utilized for well over a<br />

century. <strong>The</strong> stamping and assembly processes used in the manufacture<br />

of these structures have advanced dramatically during the<br />

past 20 years.<br />

Old Rules No Longer Apply<br />

New three-dimensional (3D) stamping technology for die-producing<br />

laminated stacks offers medical design engineers geometric<br />

freedom that was previously unattainable. Nearly any 3D<br />

shape can be produced, permitting electromagnetic cores to be<br />

designed to conform to confined spaces. <strong>The</strong> core’s surface intersections,<br />

once rigidly fixed at 90˚, can now follow a more ideal<br />

wire path. Integral mounting surfaces or features may be added<br />

to the core, eliminating the need for additional mounting hardware.<br />

Holes (round or otherwise) can not only be included in the<br />

core, they can also be perpendicular or parallel to the core’s axis.<br />

All this can be achieved inside a single progressive lamination die,<br />

without secondary operations.<br />

Interlocking lamination dies brought a new level of flexible<br />

automation to the electric motor manufacturing industry by<br />

dynamically adjusting the skew angle of rotor cores in response to<br />

material thickness and stack height, and by indexing the stack to<br />

evenly distribute coil stock gamma (variations in thickness) in the<br />

finished stack.<br />

Figures 1 through 4 illustrate how Varilok principles can be<br />

applied to actual products. <strong>The</strong>se are only typical applications of<br />

the system and should not imply that the process is in any way<br />

limited to these designs.<br />

Figure 1 portrays normal<br />

and sectional views of stator<br />

segments. <strong>The</strong> same geometry<br />

is possible with a common<br />

one-piece stator core.<br />

Figure 1 – Stator Core Segments<br />

Tom Neuenschwander<br />

Vice President, Technology<br />

LH Industries Corp.<br />

Rotor and Stator Cores<br />

<strong>The</strong> rotor and stator cores<br />

produced via interlock die<br />

systems are measurably<br />

improved over cores<br />

Motor Technology:<br />

TECHNOLOGY<br />

Varilok Stamping Process Changes the<br />

Rules for Design of Laminated Stacks<br />

produced by the conventional means of stamping loose laminations,<br />

stacking and skewing the lams in a fixture, and joining the<br />

stack together by welding or keying. In addition to reductions in<br />

labor cost and improved productivity, this technology brought a<br />

new level of precision to the laminated cores produced and to the<br />

handling of individual laminations and the stack inside the die.<br />

Not the least of these quality improvements is the improved balance<br />

of the finished cores.<br />

Die designs have been continually enhanced to accommodate an<br />

ever-increasing number of variations between individual laminations<br />

in a given stack. For example, computer-controlled cam<br />

operations in the die—necessary to produce the end laminations<br />

that separate one stack from the next—also permit the inclusion<br />

of other variations in the stack. Shaft hole punches, relief punches<br />

and counterbore punches are all programmable to allow creation<br />

of complex part geometries. However, each lamination in<br />

the motor stack typically shares a common outside periphery,<br />

providing common choke surfaces at the assembly station.<br />

Figure 2 shows application of several unique Varilok features to a<br />

linear voice coil motor core. Integral mounting features and<br />

precise openings to locate guides for the actuator are utilized.<br />

Limitless Stack<br />

Geometries<br />

New techniques for stamping<br />

3D stacks open new<br />

possibilities. Part geometries<br />

often considered impossible<br />

to produce in a progressive<br />

interlock die are now<br />

achievable. Programmable<br />

punches may be utilized for Figure 2 – Linear Voice Coil Motor Core<br />

trimming multiple outside<br />

shapes on individual laminations; discrete segments on a given<br />

lamination layer offer still greater geometric flexibility; and servodriven<br />

die modules accommodate a greater number of trim stations<br />

in a die of reasonable size.<br />

continued on page 90<br />

BONEZone • Winter 2005 89


TECHNOLOGY<br />

Motor Technology, continued from page 89<br />

Virtually any outside shape is possible, as is nearly any type of<br />

cavity or opening into the part, through or blind. This is<br />

achieved by establishing a basic part recipe: select a desired core<br />

shape, determine which surface(s) of the part should be normal<br />

to the die line and then pass horizontal cutting planes through<br />

the part with a vertical spacing equal to the thickness of stock to<br />

be used.<br />

Figure 3 illustrates non-moving electromagnetic cores used, in<br />

this instance, in automotive ignition systems. Similar shapes<br />

might be preferable for other uses.<br />

Figure 3 – Auto Ignition Pencil Cores<br />

90 BONEZone • Winter 2005<br />

This provides the recipe, the<br />

shape of each individual<br />

lamination, and the order in<br />

which individual laminations<br />

must be produced to<br />

yield the final desired 3D<br />

shape. In turn, this will dictate<br />

the number of programmable<br />

cutting stations and<br />

the proper position of each<br />

in the tool.<br />

Each trim or contouring punch must be enabled/disabled so that<br />

it influences only the particular lamination(s) for which it is<br />

intended. Each lamination is individually trimmed to its desired<br />

shape and carried in the progressive strip to arrive in the correct<br />

order at the assembly or choke station.<br />

Control of the Process<br />

One feature present in each lamination except the first (usually<br />

called the “end”) lamination is an interlock feature. <strong>The</strong> interlock<br />

tabs or “bosses” may be shaped and located as required. Each<br />

interlock feature extends from one lamination to enter the adjacent<br />

lam below; thus, each subsequent lam is locked together in<br />

a stack.<br />

<strong>The</strong> “end” lamination has an opening to receive an interlock, but<br />

has no interlock feature to extend into the lam below it. Hence,<br />

it keeps the stack it is attached to from locking to the stack<br />

immediately below it. In this manner, stacks can be produced<br />

sequentially and continuously, keeping the choke station constantly<br />

filled with parts, which is essential to generating the consistent<br />

back-pressure needed to interlock parts together.<br />

Figure 4 provides a look at how a larger cylindrical surface can be<br />

manufactured, in this example for a generator pole piece.<br />

<strong>The</strong> peripheries of each lamination are die-cut, so close tolerances<br />

and high repeatability are a given. All part dimensions that run<br />

perpendicular to the pass line of the tool (for example, the part’s<br />

overall height) are to some extent dependent on the stack-up of<br />

stock thickness. Coil stock on the thin side of its range produces<br />

shorter stacks, while<br />

thick stock produces<br />

taller stacks. This<br />

does not mean that<br />

action cannot be<br />

taken to mitigate the<br />

accumulation—plus<br />

or minus—of stock<br />

thickness variance.<br />

<strong>The</strong> die control sys-<br />

Figure 4 – Generator Pole Piece Cores<br />

tem to manage the<br />

programmable die functions and servo actions described must<br />

offer unrivalled flexibility. Its basic features should match the<br />

complexity of the tool to be run, and it must handle important<br />

matters such as part recipes, die protection, diagnostics, die I/O<br />

for all actuable die features, servo motor operations, production<br />

scheduling and even coil stock measurement. By either adding or<br />

removing a lam, stack height adjustments can be produced that<br />

improve the dimensional accuracy of the finished product. This<br />

can be accomplished either with a stock measuring system in<br />

place or by simply adjusting the lamination counts.<br />

Stamped Parts for Other Purposes<br />

Although these newer technologies were initially employed in<br />

tools for the production of electromagnetic components, laminated<br />

structures produced with these methods can be used for purely<br />

mechanical reasons, as in substitution for machined or cast parts.<br />

Die-cut edges are extremely accurate and repetitive, and even<br />

those features whose depth or height is determined by lamination<br />

stack-up dimensions are generally as accurate as can be attained<br />

by other more common manufacturing methods.<br />

Summary<br />

<strong>The</strong> Varilok process was not engineered for any specific product<br />

and is not limited in application to any specific industry.<br />

Growing naturally from other advancements in die/stamping<br />

technology, it changes the fundamental geometric rules of lamination<br />

stamping and now offers new opportunity for application<br />

in the manufacture of medical devices.<br />

LH Industries Corp. designs and manufactures progressive stamping<br />

dies and industrial control systems and provides contract stamping<br />

services in its 80,000 square foot. facility. L.H. Carbide, a sister<br />

company, manufactures progressive tooling and dies. Varilok is a<br />

trademark of L.H. Carbide Corporation.<br />

LH Industries Corp.<br />

4420 Clubview Drive<br />

Fort Wayne, IN 46804-4498<br />

USA<br />

260-432-5563 (phone)<br />

260-432-2503 (fax)<br />

Web: www.lhindustries.com<br />

E-mail: tneuensc@lhindustries.com


Introduction<br />

Used to make gun barrels more than 100 years ago, gundrilling is<br />

the process of boring long or deep holes. Back then, it was a particularly<br />

time consuming and costly manufacturing process.<br />

Today, gundrilling is a reliable high-production method used to<br />

create both long and short holes. However, it is still regarded as a<br />

“black art” process that is best left to the experts. This should not<br />

be the case.<br />

Gundrilling is commonly employed for the production of cannulated<br />

intramedullary devices as nails, screws and cannulated<br />

instruments such as drills. Gundrilling provides very straight<br />

holes with extremely close tolerance and excellent surface finish<br />

in diameters as small as .040” (1mm).<br />

Gundrills<br />

A gundrill consists of a hollow carbon steel tube with a V-shaped<br />

groove or flute along its length, and a carbide cutting tip ground<br />

with a similar flute. <strong>The</strong> tip contains a hole below the cutting<br />

edge that aligns with the hole in the tube. <strong>The</strong> hole allows cutting<br />

oil to pass at high pressure through the shank and over the<br />

tip to lubricate, cool and flush chips back along the V flute. See<br />

Exhibit 1, Drill Construction.<br />

Exhibit 1: Drill Construction<br />

<strong>The</strong> drill point is typically at one-quarter that of the diameter of<br />

the drill. <strong>The</strong> tip is ground so that, as the drill rotates, the tip<br />

cuts only on the left side of the hole center—the right side being<br />

ground to clearance angles to allow cutting oil to pass, as shown<br />

in Exhibit 2, General Purpose Nose Grind.<br />

Exhibit 2: General Purpose Nose Grind<br />

Neil Ryall<br />

Sales Manager<br />

Kays Engineering Inc.<br />

TECHNOLOGY<br />

Gundrilling:<br />

Should We Do It Ourselves?<br />

<strong>The</strong> net result is a tool that, due to cutting forces, wants to move<br />

its eccentric point to the hole center, but is prevented from doing<br />

so by the remainder of the tip diameter. This side pressure is<br />

absorbed by a support or wear pad (See Exhibit 3, Drill Tip<br />

Nomenclature.) that rubs and burnishes the hole, effectively creating<br />

its own guide bushing as it drills. Once set on its path, the<br />

drill locks itself into a direction and follows it without deviation.<br />

<strong>The</strong> resultant<br />

hole is virtually<br />

identical to the<br />

size of the drill<br />

used and yields a<br />

fine burnished<br />

finish and a hole<br />

witha practically<br />

zero deviation<br />

from its path.<br />

Exhibit 3: Drill Tip Nomenclature<br />

As the drill point<br />

is eccentric and cannot be self-started, it must be supported by<br />

special set-ups. It is not suggested that limited success is obtainable<br />

on machining or turning centers where high pressure<br />

“through the tool” coolant supplies are available; but, it can only<br />

be limited. Difficulties related to drill shank support, starting<br />

conditions, tool change and hole straightness, as well as actual<br />

maximum coolant pressure dictated by method of transfer to the<br />

tool, will be the limiting factors. <strong>The</strong> hole specifications for<br />

implants, drills and screws are so critical that their production is<br />

often beyond the capability of conventional CNC machines.<br />

Certain situations demand the use of gundrilling machines.<br />

Gundrilling Machines<br />

Gundrilling machines come in numerous configurations according<br />

to a particular industry sector and application. Within the<br />

medical device industry, machinery is typically characterized by<br />

the use of single-, twin- or multi-spindle machines with drilling<br />

stroke lengths of 15”, 30” or 48”—configurations characterized<br />

by compactness and ease of use. For instance, Exhibit 4 on the<br />

following page shows an Eldorado M75 machine with 15” nominal<br />

stroke supplied for the manufacture of bone screws and drill<br />

guides.<br />

continued on page 92<br />

BONEZone • Winter 2005 91


TECHNOLOGY<br />

Gundrilling, continued from page 91<br />

Exhibit 4: Eldorado Model M75-15 with<br />

Part Counter Rotation<br />

<strong>The</strong> single or multiple drilling spindles and slides are horizontally<br />

mounted with fixed work tables. Parts may be fixtured between a<br />

part counter rotation driven chuck and tailstock with a pneumatic<br />

advance/retract rotating female support cone. Both variable<br />

spindle speed motors and feed drive servos are PLC-controlled<br />

with programmable operator interfaces.<br />

Critical to a gundrilling machine’s performance is its initial build<br />

quality. This precursor to success is not always understood. Some<br />

users believe that a relatively simple process such as gundrilling<br />

demands little sophistication in the design and production of<br />

machinery—a belief with which this author strongly disagrees,<br />

arguing that compromise is unacceptable in relation to hole<br />

straightness and sizing, drill life and finish integrity.<br />

<strong>The</strong>re is no substitute for the provision of hardened box ways,<br />

hand-scraped surfaces and laborious alignment protocols in the<br />

production of precision high production machinery. Gundrilling<br />

machines must follow this discipline. Linear ways and milled<br />

wear surfaces, while perhaps acceptable for other types of manufacturing<br />

machinery, cannot provide equivalent long-term performance<br />

and reliability to the aforementioned build standards.<br />

Set-up<br />

In most applications, set-up consists of a spindle assembly driven<br />

by an AC servo and precision ball screw. An in-line chip box collects<br />

the returning cutting oil and chips as they are flushed back<br />

along the drill flute. <strong>The</strong> part is held by the chip box mounted<br />

part counter rotation drive and rotating tailstock support. <strong>The</strong><br />

drill is held in the spindle, if necessary using a suitable drill driver<br />

adaptor, and the drill tip and shank pass through a drill bushing,<br />

as shown in Exhibit 5, Gundrilling Drill Basics.<br />

92 BONEZone • Winter 2005<br />

<strong>The</strong> drill bushing is critical.<br />

It supports the drill<br />

so that it can start to cut,<br />

considering the eccentric<br />

point, and controls the<br />

initial path of the drill. It<br />

must be set to tolerances<br />

of “gundrilling standards,”<br />

typically drill<br />

diameter -0/+.0002”. Any<br />

more tolerance and the<br />

drill could easily deviate, giving greater runout and, in severe<br />

cases, premature drill wear and breakage. <strong>The</strong> drill bush should<br />

always make physical contact with the work face ensuring maximum<br />

possible support of the drill, avoiding both leakage of the<br />

high pressure coolant and also chip entrapment. All coolant and<br />

chips must pass back along the drill flute.<br />

Exhibit 5: Gundrilling Drill Basics<br />

Whip guide assemblies are mounted between the spindle and rear<br />

of the chip box. <strong>The</strong>y are employed to support long or extra long<br />

drill shanks and to minimize vibration. <strong>The</strong>y will also travel<br />

along the slide being collected by the carriage as it advances and<br />

being dragged back to home position at the end of the cycle. In<br />

most applications, the whip guide inserts are made of molded<br />

polyurethane and either round holed or contoured to the drill<br />

cross section (usually for the rear of the chip box only). <strong>The</strong>y will<br />

be a good fit to the drill shank and rotate in bearings to avoid<br />

drag.<br />

It is generally accepted that a whip guide support is required for<br />

up to every 40:1 length to diameter ratio of unsupported length<br />

between spindle and chip box. Example: for a drill diameter of<br />

10mm and an unsupported length of 500mm. 500/10 = 50:1= 1 x<br />

whip guide will be needed.<br />

Chip Removal<br />

Chips must be removed at a rate equal to or greater than that at<br />

which they are being produced. To do so, the cutting edges and


earing pad must be lubricated and cooled. High pressure<br />

coolant is introduced into the center of the drill tube through the<br />

spindle of the gundrilling machine to help break and evacuate<br />

the chips along the V groove of the tool and out of the hole.<br />

<strong>The</strong> coolant, usually mineral oil, travels through the tubular drill<br />

shank, through the hole in the tip, and flushes the chips back<br />

along the drill flute and into a catchment area known as a chip<br />

box. If a “balanced condition” exists—whereby chips are being<br />

flushed and removed freely and steadily—then drilling is continuous<br />

and uninterrupted until completion.<br />

<strong>The</strong> Drilling Operation<br />

<strong>The</strong> drill is set up in the spindle and supported by the traveling<br />

whip guide and rear chip box whip guide. <strong>The</strong> correct drill bushing<br />

is installed and lies in contact with the work piece which, in<br />

turn, is mounted in the counter rotation chuck and tailstock support.<br />

Parameters are programmed into the machine control.<br />

Primary considerations include spindle speed, feed or penetration<br />

rate and coolant pressure/flow.<br />

Spindle speed – <strong>The</strong> optimal speed is determined mostly<br />

by the amount of heat generation at the cutting<br />

edge. Overspeed is often evidenced by chip discoloration,<br />

but primarily by the wear rate of the outer<br />

corner of the tool. Other contributory factors to the<br />

actual cutting speed include the hardness and structure<br />

of material being cut; coolant type, pressure and flow;<br />

the grade of carbide and quality of the gundrilling<br />

tool; and the primal quality and current condition of<br />

the machine itself.<br />

Feed (penetration) rate – <strong>The</strong> optimum feed rate is that needed to<br />

form a controllable chip while balancing the wear rate of the<br />

drill’s cutting edges. Too slow, and edges may “rub” work, hardening<br />

the face of the material. Too fast, and the cutting force<br />

may twist the drill shank and cause vibration, shocking the tip.<br />

Penetration rates vary from .375 to 4.000 IPM in the alloys mentioned<br />

in Exhibit 6, subject to material condition and hardness.<br />

Coolant pressure/flow – Unlike less critical machining processes<br />

such as conventional drilling and turning, in gundrilling operations,<br />

the coolant must achieve three objectives: cool, remove<br />

chips as fast and as efficiently as possible, and lubricate the cutting<br />

edges and the support or wear pads on the drill periphery.<br />

(This latter factor is often overlooked and may result in friction,<br />

overheating, poor finish, premature drill wear and potential<br />

breakage.)<br />

Lubricants<br />

Gundrilling oils should be selected with the greatest care. <strong>The</strong>y<br />

must offer high lubricity with extreme pressure additives to withstand<br />

the burnishing action of the wear pads. To maximize tool<br />

life, avoid the use of soluble oils unless absolutely necessary, as<br />

they invariably do not have the same lubrication capability as<br />

these specialist oils. However, consideration may need to be given<br />

to soluble oils if oil additives such as chlorine are unacceptable.<br />

Oil Temperature<br />

Overheating causes denaturing of the oil, consequential<br />

deterioration of hole quality, and potential tool breakage.<br />

Generally, air coolers or water-type heat exchangers are fitted to<br />

coolant systems as standard. Where environments experience<br />

high ambient temperatures and have no plant cooling water, then<br />

refrigerated cooling systems should be fitted.<br />

Cutting Parameters<br />

Primarily, metals employed in the manufacture of medical devices<br />

fall into one of three categories, none of which pose especially<br />

difficult challenges to the gundrilling process. Of the three types,<br />

titanium is the easiest to gundrill. Cutting parameters for these<br />

materials are indicated in Exhibit 6.<br />

• Precipitation hardening stainless steels - 15-5 PH, 17-4 PH<br />

• Austenitic stainless steels - 310, 316, 320 Series<br />

• Titanium - Ti-6Al-4V<br />

Material Hardness Bhn Cutting Speed<br />

SFM (Mpm)<br />

TECHNOLOGY<br />

Exhibit 6: Gundrilling Cutting Parameters for<br />

Typical Medical Device Materials<br />

Penetration Rate<br />

IPM (mmpm)<br />

15-5 PH, 17-4 PH 275 - 325 150 (46M) .700 (18mm) to<br />

.870 (22mm)<br />

310, 316, 321<br />

Series<br />

135 - 185 210 (64M) 1.500 (38mm) to<br />

2.160 (55mm) *<br />

Ti-6Al-4V 320 - 380 100 (30M) .625 (16mm) to<br />

.750 (19mm) **<br />

* Assumes free-cutting drawn material. Forged materials, in particular, will be<br />

up to 50% less.<br />

** With rigid, well-aligned set-up and fixturing; regulated oil temperature of<br />

less than 100° F, this figure may be increased significantly. It is not unusual<br />

to drill at 1.2” (30mm).<br />

Example: Knee Nail Ti-6Al-4V .213” diameter hole through x<br />

15.787” (400mm) long = 15.787 divided by .800 = 19.7 min.<br />

drill time (conservatively), but possibly 15 minutes.<br />

Benefits<br />

Not only, as described, can gundrilling achieve the highest quality<br />

holes in terms of diameter tolerance and surface finish in a single<br />

drill pass, but a gundrilled hole can be almost “perfect” in terms<br />

of straightness. Deviation in concentricity to the outside diameter<br />

is a function of build quality, machine condition and set-up, as<br />

well as maintenance of consumable/wearable parts. It is generally<br />

accepted that hole straightness with a rotating drill will be within<br />

.001”/1” (0.1mm/100mm) total indicator reading (TIR). With<br />

counter rotation of the part, 50% of this value i.e. .0005”/1”<br />

continued on page 94<br />

BONEZone • Winter 2005 93


TECHNOLOGY<br />

Gundrilling, continued from page 93<br />

(0.05mm/100mm) is achievable. This is a good working average,<br />

but considerably better result are obtainable with customer<br />

collaboration and “fine tuning” at the time of machine assembly<br />

and run off.<br />

Conclusion<br />

Gundrilling is often underappreciated as a simple, reliable, cost<br />

effective, in-house process. However, gundrilling is no longer a<br />

discipline beyond the comprehension or mastery of the OEM.<br />

<strong>The</strong> versatility of gundrilling machinery makes the process ideally<br />

suited for low as well as high volume production. With correct<br />

set-up, it is a matter of “pressing a button” and waiting until the<br />

hole is complete, even for considerable depths of 150 times drill<br />

diameter and beyond.<br />

<strong>The</strong> type of component or device being produced obviously dictates<br />

the preferred drilling method; however, gundrilling is now<br />

an affordable consideration whose benefits are in reach of even<br />

smaller users that demand both quality and flexibility for the<br />

drilling of both long and short holes. As a rule-of-thumb, gundrilling<br />

proves faster than conventional or high performance<br />

If you knew the final destination of your design would end up in your body, of<br />

course you’d prefer using only the best available material. But whether it’s for<br />

you or a total stranger in need, for long-life and performance of your device,<br />

always start with premium quality material.<br />

helical twin flute drilling when hole depth is in excess of ten<br />

times diameter, and yields unrivalled straightness, hole tolerance<br />

and surface finish.<br />

With the benefits of today’s technology, gundrilling is a realistic<br />

upgrade to the OEM tooling arsenal that can prove to be a cost<br />

effective alternative for meeting capacity requirements.<br />

Kays Engineering Inc. specializes in the design, manufacture and<br />

build of DeHoff and Eldorado precision deep hole drilling machines<br />

and high pressure coolant systems. <strong>The</strong> company provides technical<br />

support and field service for this equipment and also designs and<br />

manufactures custom machine tools and one-of-a-kind processing<br />

equipment. Neal Ryall is a Sales Manager for Kays and can be<br />

reached at nryall@kays-dehoff.com.<br />

Kays Engineering, Inc.<br />

900 Industrial Drive<br />

Marshall, MO 65340 USA<br />

660-886-9929 (phone)<br />

660-886-2249 (fax)<br />

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Introduction<br />

Due to their high degree of biocompatibility and their high<br />

strength-to-weight ratios, titanium and titanium alloys have long<br />

been used in the manufacture of biomedical devices. Given the<br />

significant advances in the fields of powder metallurgy and, more<br />

specifically, metal injection molding, there is an increasing<br />

amount of interest in the use of spherical titanium powders in<br />

the manufacture of orthopaedic implants.<br />

Techniques for producing spherical titanium powders include the<br />

Plasma Rotating Electrode Process (PREP) and Gas Atomization<br />

—both of which yield spherical titanium powders at significant<br />

throughput. Each process produces powders with distinct characteristics<br />

in terms of size distribution and purity. However, neither<br />

truly addresses the needs of providing high purity (


TECHNOLOGY<br />

Plasma Atomization, continued from page 97<br />

Droplets shear off in a superheated state, com-pletely consuming<br />

the wire, as demonstrated in Exhibit 3. <strong>The</strong> droplets disperse,<br />

then fall down a tall water jacket argon-filled tower. <strong>The</strong> droplets<br />

spend enough time in freefall to physically transform into their<br />

most natural state dictated by surface tension: a perfect sphere.<br />

Exhibit 3:<br />

Three Argon Plasma Torch Jets Converging on Titanium Wire<br />

<strong>The</strong> spheres are collected semi-continuously under an argon<br />

blanket, and then sieved generally into three powder sizes: 0-<br />

45µm, 45-75µm and +75µm. <strong>The</strong> biggest challenge when using<br />

metallic powders in a biomedical component manufacturing<br />

process is ensuring that the final component exhibits properties<br />

comparable to that of machined, cast, wrought or forged components.<br />

Metal Injection Molding (MIM)<br />

MIM is a technique derived from plastic injection molding. With<br />

MIM, metallic powders are blended with thermoplastic binders<br />

and injected into a complexly-shaped, totally enclosed mold at<br />

temperatures around 150oC. <strong>The</strong> polymeric material is then dissolved<br />

or burnt off from the “green” component in the de-binding<br />

stage.<br />

<strong>The</strong> subsequent porous component is then sintered to approach<br />

full density characteristics. <strong>The</strong> problem when using MIM with<br />

titanium and other reactive alloys is that during each step, the<br />

risk for contamination elevates. Titanium reacts with oxygen,<br />

hydrogen, nitrogen and carbon, thus modifying detrimentally the<br />

mechanical properties of the final component.<br />

With plasma-atomized spherical titanium powders—given the<br />

strict controls on the wire and minimal pick-up of contaminants<br />

during processing—raw MIM powder initially possesses excellent<br />

purity, a step above powders produced from other processes.<br />

Typically, 0-45µm sized powders are used. Since plasma-atomized<br />

titanium powders are very flowable at fine size ranges, minimal<br />

amounts of binder are required to ensure that the mold is completely<br />

filled with the feedstock.<br />

98 BONEZone • Winter 2005<br />

Given the bonded structure of the intermediate component, the<br />

carbon-based polymer can easily be liberated during the de-binding<br />

stage, leaving virtually no carbon to contaminate the final<br />

component. Once it is sintered, the final component produced<br />

with plasma-atomized titanium powders exhibits excellent<br />

mechanical properties.<br />

Summary<br />

Plasma-atomized titanium powders have been used extensively<br />

for surface coatings of porous structures on orthopaedic implants.<br />

Varying size ranges of powders have been used for laser sintering<br />

and laser deposition in the rapid prototyping and rapid manufacturing<br />

of components. As the orthopaedic implant industry<br />

comes to embrace powder metallurgy—and, more particularly,<br />

techniques such as MIM—spherical titanium powders produced<br />

by plasma atomization will represent a key underpinning in the<br />

emergence and acceptance of these techniques.<br />

Thomas Whitton is Business Development Manager at AP&C<br />

Advanced Powders and Coatings Inc., a division of Raymor<br />

Industries Inc. He can be reached at: twhitton@raymor.com.<br />

AP&C Advanced Powders and Coatings is a wholly-owned subsidiary<br />

of Raymor Industries. AP&C’s mission is to become the leading<br />

Canadian producer of advanced materials and nanomaterials for<br />

high value-added applications. AP&C comprises four operating divisions:<br />

(1) nanotechnology products, including nano-powders, nanocoatings<br />

and single-walled carbon nanotubes (C-SWNT) for “the<br />

applications of tomorrow;” (2) thermal spray coatings, which largely<br />

targets military, aeronautical, aerospace, specialized industrial and<br />

mining applications; (3) spherical metallic powders, primarily used<br />

for biomedical and aerospace applications; and (4) net-shape forming,<br />

a component manufacturing technique used for ballistic protection<br />

and other aerospace and military applications.<br />

AP&C Advanced Powders and Coatings, Inc.<br />

2000 William St.<br />

Montreal, Quebec<br />

H3J 1R8 CANADA<br />

514-932-8805 (phone)<br />

514-932-5635 (fax)<br />

References<br />

Froes, F.H., Developments in Titanium P/M, University of Idaho<br />

Web Site, 2002.<br />

Smagorinski, M et al., Production of Spherical Titanium Powder<br />

by Plasma Atomization, PM2TEC 2002, Orlando, June 2002.<br />

Limberg, W., Aust, W. et al, Metal Injection Moulding of an<br />

Advanced Bone Screw 7Nb alloy Powder, PM2004, Vienna,<br />

October 2004.


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to learn more.


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Introduction<br />

Acrylic bone cement has been on the market for over 30 years,<br />

and surgeons have used over 18 million doses from one manufacturer<br />

alone 1<br />

to secure prostheses such as hip and knee replacements.<br />

Various biomedical corporations now produce versions of<br />

this material, along with mixing devices.<br />

How does a surgeon decide which brand to use? Researchers have<br />

carried out various studies looking at how mixing affects certain<br />

properties of bone cement. In addition, different brands of<br />

cements have been compared. However, until now, no study has<br />

examined the interaction between the mixers and cements over a<br />

broad range of properties. <strong>The</strong> following recounts an attempt to<br />

determine if the choice of mixer or cement is critical for bone<br />

cement use.<br />

Process<br />

To answer this question objectively, two of the most popular<br />

bone cements as well as three of the marketed mixing systems<br />

were compared. One manufacturer produced Cement A along<br />

with Mixer 3. A different company markets Cement B, Mixer 1,<br />

and Mixer 2. All mixers are vacuum assisted devices, which are<br />

popular for reducing the methacrylate fumes 2 released by the<br />

cements. Application of the vacuum also reduces the porosity 3 of<br />

the resulting bonds, increasing the mechanical integrity. Cement<br />

A was mixed with Mixers 1 and 3; Mixers 1 and 2 were used for<br />

Cement 2. All samples were tested for setting time, porosity, tensile<br />

strength and flexural strength.<br />

Both the A and B materials are two-part poly (methyl methacrylate)<br />

(PMMA) bone cements. Each of the three mixing systems is<br />

designed to be used with bone cements in a clinical setting to<br />

prepare a twodose shot of cement under vacuum.<br />

Mixing<br />

Each mixing step was accomplished in accordance with the manufacturer’s<br />

instructions for the particular bone cement and mixer.<br />

Liquid was added to the mixer before the powder when mixing<br />

Cement A and was used in the opposite order for Cement B. <strong>The</strong><br />

manufacturers recommended using a vacuum of about 22 inch<br />

Hg for Cement B and approximately 25 inch Hg for Cement A.<br />

Mixer 1 and Mixer 3 were operated with 30 seconds of mixing,<br />

Jennifer Robertson, Ph.D., <strong>The</strong>rmal/Physical Group Leader<br />

Grant Hancock, Equipment and Maintenance Manager<br />

James Rancourt, Ph.D., President and Technical Director<br />

Polymer Solutions Incorporated<br />

TESTING<br />

Comparative Analysis of<br />

Bone Cements and Mixers<br />

whereas the Mixer 2 system was operated with one minute. Due<br />

to differences in the viscosities and working times for the two<br />

cements, Cement A was injected into the molds 2.5 minutes after<br />

starting the mixing while Cement B was injected after 3.5 minutes.<br />

Cement A exhibited a significantly higher viscosity than did<br />

Cement B. A longer pre-injection time could be employed for<br />

Cement B, since it took a longer time for an equivalent viscosity<br />

to develop.<br />

Mixer 1 and Mixer 3 were used to prepare a total of twelve mixes<br />

of Cement A, alternating the mixer with each batch. Mixer 1 and<br />

Mixer 2 were then used in an alternating fashion to prepare<br />

twelve total batches of Cement B. In this manner, six sets of test<br />

bars from each mixer/cement combination were prepared for<br />

porosity testing. <strong>The</strong> entire process was then repeated to generate<br />

mechanical test specimens from another six sets of bars for each<br />

mixer/cement combination.<br />

During the molding process, Cement A was noted to be significantly<br />

more viscous than Cement B. <strong>The</strong>refore, significantly<br />

more force was required in order to fill the molds when we used<br />

Cement A. At times, an audible pop was heard from a bubble<br />

breaking. <strong>The</strong> manufacturer had reported that Cement A often<br />

showed large voids in the end of the mold opposite the filling<br />

port, and this was indeed observed. <strong>The</strong> lower viscosity of<br />

Cement B evidently helped to alleviate this problem, as no large<br />

voids were observed in Cement B specimens.<br />

Setting Time<br />

Cement A was blended using both Mixer 1 and Mixer 3, and the<br />

cure of the resulting samples was monitored for setting time by<br />

insertion of a thermocouple attached to a MicroDaq recorder<br />

into the end of the mold. Similarly, Cement B was mixed in both<br />

Mixer 1 and Mixer 2 to determine any variations resulting from<br />

the different mixers. <strong>The</strong>se molded samples were then used for<br />

porosity measurements.<br />

Exhibit 1 shows the setting times for the cement mixes. <strong>The</strong>se<br />

were calculated based on ASTM F451 4 , which defines setting<br />

time as that at which the cement reaches the average of the<br />

continued on page 102<br />

BONEZone • Winter 2005 101


TESTING<br />

Comparative Analysis, continued from page 101<br />

ambient temperature and the maximum temperature. In addition<br />

to the average and standard deviation values shown in the Exhibit<br />

1, additional statistical analyses were performed on the data. It<br />

was determined that all setting time data provided a normal distribution,<br />

and a One-Way ANOVA (analysis of variance) calculation<br />

indicated that no statistically significant differences in setting<br />

time existed between the two mixers for a given cement. <strong>The</strong>re<br />

was, however, a significant difference in setting times for the two<br />

cements with Cement B having a longer setting time relative to<br />

Cement A. This would allow a surgeon an increased window in<br />

which to work with this cement in a clinical situation.<br />

<strong>The</strong> maximum temperature reached by a given cement/mixer<br />

combination varied, although this seemed to have little effect on<br />

the setting times. In addition, the ambient temperature changed<br />

somewhat during the course of a day’s molding. Both of these<br />

temperatures were recorded using the thermocouple. (See<br />

Exhibit 1.)<br />

Exhibit 1. Setting Time Results for the Two Cements and Three Mixers<br />

Though mixing is carried out under vacuum, it is possible for air<br />

to become trapped in the cement, leading to porosity. Clearly,<br />

any voids in a molded component could lead to weakening,<br />

which is to be avoided in in vivo applications. <strong>The</strong>refore, porosity<br />

of the prepared bone cement bars was measured. Variations both<br />

between mixers and between cements are relevant.<br />

To test the porosity two bars from each of the first batch sets<br />

were machined down to a specified size and then stained on both<br />

sides with a machine dye. Both surfaces of each bar were handsanded<br />

to remove surface dye. Any dye still visible existed in a<br />

porous void below the level of the surface. <strong>The</strong> porosity level was<br />

determined using a digital technique to quantify the level of dye<br />

visible on each side of a bar. This method analyzed both sides of<br />

each bar in a two bar set and resulted in one porosity value for<br />

the four surfaces.<br />

Exhibit 2 summarizes the results of the porosity testing. One can<br />

see that the uncertainty inherent in these measurements is quite<br />

large, as the standard deviation is often larger than the average of<br />

the readings. Statistical analysis of the porosity results showed<br />

that the data were not normally distributed, so an ANOVA calculation<br />

could not be performed. This is not unexpected since<br />

102 BONEZone • Winter 2005<br />

Exhibit 2. Results of Porosity Testing<br />

Cement A has a significantly higher viscosity<br />

relative to Cement B, making it<br />

more difficult to fill the molds and leading<br />

to increased occurrence of large voids.<br />

From the data, it is evident that Cement A<br />

has a higher average percent porosity than<br />

Cement B. Also, it appears that Mixer 3<br />

resulted in a higher mean porosity. It<br />

should be noted, though, that Mixer 3 was<br />

used only for Cement A, and Mixer 2 only<br />

for Cement B, so this comparison is somewhat<br />

skewed.<br />

Tensile Testing<br />

<strong>The</strong> tensile mechanical properties of the bone cements on each<br />

set of bars were measured in accordance with ASTM D638-03 5 .<br />

Type V dog bone specimens were machined from the molded<br />

bars and tested.<br />

Tensile testing results are summarized in Exhibits 3 and 4.<br />

Statistical analysis of the data revealed that tensile strength and<br />

modulus results provided a normal distribution, but the distribution<br />

of the elongation data was not normal over all samples. An<br />

ANOVA calculation showed that Cement A exhibited a higher<br />

tensile strength relative to Cement B, while the trend for the<br />

modulus was the opposite. Since the distribution of the data was<br />

not normal, an ANOVA could not be performed on the elongation<br />

data. However, the elongation was numerically greater for<br />

Cement A than Cement B, although the difference was slight.<br />

One can note, though, that the values only range from around<br />

2% to 3% for either of the cements, so it is not clear that this<br />

difference would be important in practice.


Flexural Testing<br />

<strong>The</strong> flexural properties of bone cements are also important since<br />

many physiological motions are not pure tension and compression.<br />

To measure these properties, mechanical testing was carried<br />

out based on ISO 5833:2002(E) 6 . Exhibits 3 and 4 also summarize<br />

results of the flexural testing. All flexural data exhibited a<br />

normal distribution. An ANOVA calculation showed that, when<br />

the mixers were compared, no statistically significant differences<br />

Exhibit 3. Results of Mechanical Testing<br />

Exhibit 4. Mechanical Properties for the Two Cements and Three Mixer<br />

TESTING<br />

were identified in the bending strength or the bending modulus.<br />

<strong>The</strong>re was a statistically significant difference between the<br />

cements, in the bending strength and the bending modulus.<br />

Cement A demonstrated a higher bending strength relative to<br />

Cement B. Conversely, Cement B showed a higher bending<br />

modulus than that observed for Cement A.<br />

Conclusions<br />

In conclusion, this testing showed the following:<br />

• <strong>The</strong> setting time was longer for<br />

Cement B than for Cement A.<br />

• Cement B was less porous than<br />

Cement A.<br />

• Cement A has a higher tensile strength<br />

than Cement B. <strong>The</strong> mixer used did<br />

not have any effect on the strength.<br />

continued on page 104<br />

BONEZone • Winter 2005 103


TESTING<br />

Comparative Analysis, continued from page 103<br />

• Cement B has a higher tensile modulus than Cement A.<br />

• Cement A has a numerically higher elongation than Cement B.<br />

• Cement A has a higher bending strength than Cement B.<br />

• Cement B has a higher bending modulus than Cement A.<br />

• <strong>The</strong> choice of mixer did not affect setting time, porosity, tensile<br />

properties, or flexural properties.<br />

Several combinations of mixers and cements were evaluated in an<br />

effort to determine whether any particular combination provided<br />

superior properties. No clear “winner” emerged. <strong>The</strong> choice of a<br />

mixer seems to be entirely a matter of personal choice, as it was<br />

observed that the mixer had no effect on results. <strong>The</strong> cements did<br />

show some differences. Cement B offered the advantages of a<br />

longer working time and lower porosity, as well as greater tensile<br />

and flexural strength. Cement B was also easier to inject into a<br />

mold. Cement A, though, exhibited a higher modulus in tension<br />

and flex and showed a slightly higher level of elongation. <strong>The</strong><br />

trade-offs must be carefully considered to determine what will<br />

benefit not just the surgeon in ease of use, but also the patient<br />

receiving a new prosthesis.<br />

References<br />

1. http://www.stryker.com/jointreplacements/sites/bonecement/?WT.mc_id=1224<br />

2. Schlegel UJ, Sturm M, Ewerbeck V, and Breusch SJ, “Efficacy of Vacuum Bone Cement<br />

Mixing Systems in Reducing Methylmethacrylate Fume Exposure,” Acta Orthop Scand,<br />

75: 559-566, 2004.<br />

3. Wilkinson JM, Eveleigh R, Hamer AJ, Milne A, Miles AW, and Stockley I, “Effect of<br />

Mixing Technique on the Properties of Acrylic Bone-Cement,” J. Arthrop, 15: 663-667,<br />

2000.<br />

4. ASTM F451 Standard Specification for Acrylic Bone Cement, American Society for<br />

Testing and Materials, 1999.<br />

5. ASTM D638 Standard Test Method for Tensile Properties of Plastic, American Society for<br />

Testing and Materials, 2003.<br />

6. ISO 5833:2002(E) Implants for Surgery-Acrylic Resin Cements, International Standards<br />

Organization, 2002.<br />

Jennifer Robertson is the <strong>The</strong>rmal/Physical Group Leader at Polymer<br />

Solutions Incorporated. She can be reached at (540) 961-4300 or<br />

Jennifer@polymersolutions.com. Grant Hancock is the Equipment<br />

and Maintenance Manager at Polymer Solutions Incorporated. He<br />

can be reached at (540) 961-4300 or Grant@polymersolutions.com.<br />

James Rancourt is the President and Technical Director of Polymer<br />

Solutions Incorporated and can be reached at (540) 961-4300 or<br />

jim@polymersolutions.com. Polymer Solutions Inc. is a chemical<br />

analysis testing laboratory with 15 years’ experience answering difficult<br />

questions regarding polymer and plastic analysis testing. Services<br />

include rheology testing, RoHS compliance testing, differential scanning<br />

calorimetry testing, polymer synthesis, molecular weight analysis,<br />

polymer analysis testing and plastic analysis testing, including deformulation<br />

and failure analysis.<br />

Polymer Solutions Incorporated<br />

1872 Pratt Drive, #1375<br />

Blacksburg, VA 24060<br />

540-961-4300 (phone)<br />

877-961-4341 (toll-free)<br />

540-961-5778 (fax)<br />

www.polymersolutions.com<br />

info@polymersolutions.com<br />

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BONE CALENDAR<br />

Zone®<br />

JANUARY<br />

01/11-01/14 Tucson, AZ<br />

AAHS - American Association for Hand Surgery<br />

36th Annual Meeting<br />

FEBRUARY<br />

02/15-02/16 Birmingham, UK<br />

Medical Device Technology Magazine<br />

13th Annual Medical Device Technology Exhibition<br />

and European Conference<br />

MARCH<br />

03/08-03/11 San Diego, CA, USA<br />

NASS - North American Spine Society<br />

Spring Break <strong>2006</strong>: Back to the Evidence<br />

03/19-03/22 Chicago, IL, USA<br />

ORS - Orthopaedic Research Society<br />

Annual Meeting<br />

03/22-03/26 Chicago, IL, USA<br />

AAOS - American Academy of Orthopaedic Surgeons<br />

Annual Meeting<br />

03/25 Chicago, IL, USA<br />

AOFAS - American Orthopaedic Foot & Ankle Society<br />

Specialty Day Meeting<br />

MAY<br />

05/10-05/13 Montreal, Quebec, Canada<br />

SAS - Spine Arthroplasty Society<br />

SAS Summit 6<br />

05/18-05/21 Hollywood, FL, USA<br />

AANA - Arthroscopy Association of North America<br />

Annual Meeting<br />

05/20-05/24 Boston, MA, USA<br />

NAON - National Association of Orthopaedic Nurses<br />

Annual Congress<br />

05/21-05/24 Phoenix, AZ, USA<br />

BONES - Bones Society<br />

Annual Meeting<br />

05/21-05/24 Las Vegas, NV, USA<br />

CCJR - Current Concepts Institute<br />

Current Concepts in Joint Replacement - Spring <strong>2006</strong> Course<br />

05/31-06/03 Denver, CO, USA<br />

ACSM - American College of Sports Medicine<br />

Annual Meeting<br />

JUNE<br />

06/13-06/17 Bergen, Norway<br />

ISSLS - <strong>The</strong> International Society for the Study of<br />

the Lumbar Spine<br />

33rd Annual Meeting<br />

6/21-6/22 Rosemont, IL, USA<br />

OMTEC - Orthopaedic Manufacturing & Technology<br />

Exposition and Conference<br />

2nd Annual Meeting<br />

06/21-06/24 San Antonio, TX, USA<br />

AOA - American Orthopaedic Association<br />

119th Annual Meeting<br />

06/26-06/29 Davos, Switzerland<br />

European Cells & Materials Conferences<br />

ECM VII: Cartilage and Joint Repair<br />

06/29-07/02 Hershey, PA, USA<br />

AOSSM - American Orthopaedic Society for Sports Medicine<br />

32nd Annual Meeting<br />

JULY<br />

07/13-07/15 La Jolla, CA, USA<br />

AOFAS - American Orthopaedic Foot & Ankle Society<br />

22nd Annual Summer Meeting<br />

07/23-07/27 Maui, HI, USA<br />

North American Spine Society and the Japan Spine<br />

Research Society<br />

Spine Across the Sea<br />

SEPTEMBER<br />

09/07-09/09 Washington, DC, USA<br />

ASSH - American Society for Surgery of the Hand<br />

61st Annual Meeting<br />

09/13-09/16 Monterey, CA, USA<br />

SRS - Scoliosis Research Society<br />

41st Annual Meeting<br />

09/15-09/19 Philadelphia, PA, USA<br />

ASBMR - American Society for Bone and Mineral Research<br />

28th Annual Meeting<br />

09/26-09/30 Seattle, WA, USA<br />

NASS - North American Spine Society<br />

21st Annual Meeting<br />

09/27-09/29 Glasgow, Scotland<br />

BOA - British Orthopaedic Association<br />

Annual Meeting<br />

BONEZone • Winter 2005 107


BONE<br />

Zone®<br />

CLASSIFIEDS<br />

U.S. Surgical Orthopedics Manufacturer<br />

Sales Executive (International Opportunity)<br />

US and global, travel involved<br />

We are a global surgical instruments manufacturer seeking an<br />

experienced executive to lead our sales initiatives in North<br />

America. This highly visible position will report to the CEO<br />

and will provide direction and leadership to all sales initiatives<br />

required to achieve the Company’s aggressive growth<br />

plans. Extensive experience and knowledge in the medical<br />

device industry, and more specifically orthopedics, is<br />

required. This role also requires the ability to actively participate<br />

in the sales cycle, simultaneously manage several priorities,<br />

hire and develop an effective sales team and design<br />

incentive plans in alignment with corporate goals. A college<br />

degree with a career track demonstrating the ability to<br />

achieve specified sales goals and 10-15 years of experience<br />

in progressively responsible sales and management roles is<br />

required. Extensive travel, including some international. We<br />

offer an attractive compensation package including a competitive<br />

base salary, incentive bonus based on performance<br />

achievement and a comprehensive benefits plan. Contact<br />

Information: Please respond in confidence to<br />

SurgOrtho@orthoworld.com.<br />

3D Machining, Inc.<br />

QA Manager<br />

West Palm Beach, Florida<br />

Directs and coordinates activities of quality assurance department.<br />

ESSENTIAL DUTIES AND RESPONSIBILITIES include the<br />

following: Manages and supervises personnel in the department;<br />

accountable for incoming, in process and final inspection;<br />

Facilitating and conducting all ISO and customer audits;<br />

Communicating directly with customers on drawing specification<br />

/ inspection requirements; Personally participating on<br />

the floor with manufacturing for inspection, gage support,<br />

and process improvement. 3D Machining, Inc. is a privately<br />

held manufacturer of Medical Device assemblies, components,<br />

and instruments, located in South Florida. 3D is currently<br />

certified to ISO 9001:2000 and ISO 13485. Contact<br />

employment@3d-machining.com, IsoTis Orthobiologics, Vice<br />

President, Research & Development, Irvine, California.<br />

Reporting to the CEO, the Vice President of Research &<br />

Development will lead and oversee the research and product<br />

development functions for the Company (internal R&D staff<br />

of 6-8, as well as collaboration with academic collaborators).<br />

<strong>The</strong> scope of this role near term will focus heavily on managing<br />

the product development activities for the Company’s<br />

product offerings. Longer term, this individual, in close cooperation<br />

with Marketing, will provide the vision and leadership<br />

for research into areas of orthobiologics that will drive the<br />

For the most current orthopaedic employment<br />

opportunities please visit: www.OrthoCareers.com.<br />

growth of the Company in this emerging field. <strong>The</strong> VP R&D<br />

will be accountable for: • Staffing and organizing the R&D<br />

organization to facilitate rapid movement of development<br />

projects from concept to production (3-4 months) • Establish<br />

dedicated project teams for the development of specific identified<br />

projects (3-4 months) • Successfully conclude the<br />

development of the first new, identified, 3 product improvements<br />

(9-12 months) • In close cooperation with Marketing,<br />

identify, plan and initiate the development of 3 additional<br />

products (to be launched in 18-24 months). Compensation<br />

will be commensurate with the candidates education, experience<br />

and track record and will consist of a base salary, a cash<br />

bonus, stock options and a comprehensive benefits package.<br />

A comprehensive relocation package will be provided as<br />

needed. Contact Information: Ruedi Sandmeier, Ph.D., Senior<br />

Consultant, sandmeier@bioquestinc.com BioQuest, LLC.<br />

Stryker Orthopaedics<br />

Manufacturing Engineer<br />

Mahwah, New Jersey<br />

Stryker is an exceptional company with exceptional people<br />

who deliver exceptional results. We have differentiated ourselves<br />

by responding in innovative ways to the needs of our<br />

global customers and patients. We have created a work environment<br />

that attracts talented, driven people who love to win<br />

and to serve others. We hold ourselves accountable to reach<br />

or exceed our goals and to continually improve everything we<br />

do. <strong>The</strong>se attributes are shared by the employees that make<br />

up Stryker. <strong>The</strong>y are the things that bring us together. <strong>The</strong>y<br />

are the foundation of all we do. And they are the enablers of<br />

both our past and future success. RESPONSIBILITIES:<br />

Provides the project management and quality engineering<br />

support to assist the team in the completion of new product<br />

introductions including vended product. This involves the<br />

qualification & selection of suppliers & coordination of all<br />

other pre launch activities. Also supports the manufacture of<br />

orthopedic implants in the areas of manufacturing engineering,<br />

production planning, purchasing and any other functions<br />

necessary for the team to meet its customers’ needs. Must<br />

have 2-4 years of Quality, Manufacturing or Mechanical<br />

Engineering experience. Validation experience is a plus.<br />

Working knowledge of FDA & international medical device<br />

regulations. Working knowledge of Advanced Quality tools<br />

such as Failure Mode Effect Analysis (FMEA), GD&T, SPC, Root<br />

Cause Analysis, and Mistake Proofing/Poka-Yoke is a plus.<br />

Ability to work cross functionally with Product Development,<br />

Operations, QA & Marketing. Excellent project management<br />

skills. Excellent problem solving & troubleshooting skills.<br />

Excellent interpersonal & communication skills. Must be a<br />

continued on page 110<br />

BONEZone • Winter 2005 109


Classifieds, continued from page 109<br />

positive & energetic team player. Candidate must be results<br />

oriented, multitasking, quick learner & show a strong track<br />

record of meeting deadlines. Must have excellent PC skills.<br />

Must be challenged by a team-based environment which<br />

places high degree of emphasis on accountability for new<br />

product development, cost reduction and quality/GMP compliance.<br />

Have knowledge of basic manufacturing equipment<br />

& processes. Stryker is an equal employment opportunity/<br />

affirmative action employer committed to hiring a diverse<br />

workforce. Contact Information: To apply online, please visit<br />

www.stryker.com/careers. Reference Code: 3033BR.<br />

CNC Programmer<br />

Mahwah, New Jersey<br />

DESCRIPTION: Responsible for developing the manufacture of<br />

orthopedic implants in a manufacturing cell in the areas of<br />

programming, manufacturing engineering, equipment maintenance,<br />

troubleshooting, and any other functions necessary<br />

for the team to meet its customers needs. Writing and editing<br />

programs using G & M code and parametric macro programming;<br />

Setting up lathes, screw machines, EDMs,<br />

grinders, robots and milling machines and designing fixtures<br />

and gages; Project management and frequent communication<br />

with vendors concerning products, forgings, tooling, fixtures<br />

and gages; Providing technical support for quality control,<br />

process improvements, cost savings, process development<br />

projects and product launches; Training and development of<br />

operators; Writing Operation Specifications and supporting<br />

quality documents; Writing and submission of Capital<br />

Expenditure Requests. REQUIRES 4 plus years experience<br />

with CNC programming in a production/manufacturing environment.<br />

Strong PC skills along with Pro E and Master CAM<br />

experience. Effective analytical skills with demonstrated success<br />

in problem- solving. Effective verbal and written communication<br />

skills. To apply online, please visit<br />

www.stryker.com/careers. Reference Code: 3038BR.<br />

Packaging Engineer/Designer<br />

Mahwah, New Jersey<br />

DESCRIPTION: A creative designer with the ability to convey<br />

consumer feedback to innovative, functional packaging solutions<br />

for orthopedic implants and instruments. As part of a<br />

cross functional team, convert consumer feedback into innovative<br />

functional package designs. Coordinates efforts of<br />

Package Engineering and Packaging <strong>Supplier</strong>s to evaluate<br />

concept designs and convert into robust tooling. Oversees<br />

mold design based on knowledge of package technologies<br />

and packaging materials. Works closely with package engineering<br />

and quality, to evaluate and approve packaging<br />

designs through capability studies and validations. Designs,<br />

creates, and modifies drawings as needed. Supports marketing<br />

concepts through prototype development. Develops database<br />

for global packaging designs. REQUIRES minimum of 5<br />

years experience in consumer product, medial device or<br />

110 BONEZone • Winter 2005<br />

pharmaceutical package design. CAD, CAE, Pro-Engineer,<br />

Unigraphics and or Solid works expertise. Demonstrated ability<br />

to work independently or in a team environment. Must<br />

have strong verbal and written communication skills. Must<br />

have strong PC skills. To apply online, please visit www.stryker.com/careers.<br />

Reference Code: 3037BR.<br />

Senior Designer<br />

Mahwah, New Jersey<br />

DESCRIPTION: <strong>The</strong> Senior Designer will work with assigned<br />

operations team members to lead the CAD development of<br />

implants and instrumentation manufacturing models through<br />

the modeling and detailing of designs. He or She will also<br />

develop / maintain expertise in Pro E design software and act<br />

as the technical mentor in this area for the team. Modeling<br />

and detailing of implant and instrumentation manufacturing<br />

designs utilizing the PRO E design software. Develop prototypes<br />

for design verification and validation. Serve as main<br />

design interface with R&D to gather input for design and<br />

evaluation of new product. Lead the utilization/management<br />

of the Design Controls(NPDP) Design and model tooling, fixturing,<br />

gauging, and machining paths. REQUIRES 5+ years of<br />

product design experience in the medical device industry or<br />

equivalent. Expertise in a parametric CAD design package.<br />

PRO E preferred. Expertise with design controls within a regulated<br />

industry helpful. Candidates should be self-starters,<br />

have a hands-on approach and capability to work independently.<br />

To apply online, please visit www.stryker.com/careers.<br />

Reference Code: 3039BR.<br />

Teleflex Medical<br />

Director, Research and Development-OEM Orthopedics<br />

Kenosha, Wisconsin<br />

Job Description: <strong>The</strong> Director of R&D – OEM Orthopedics is a<br />

high impact role in customer- focused product development<br />

reporting to the VP of R&D for the OEM business. <strong>The</strong> scope<br />

of this role will focus heavily in creating new product concepts<br />

for orthopedic customers and delivering sound product<br />

designs to the development teams located in Wisconsin.<br />

Activities will also include frequent visits to key customers for<br />

conceptual discussions, attendance at leading universities for<br />

orthopedic procedure observation and attendance at key<br />

educational meetings in the US and abroad. Key elements<br />

critical to the success of this role will be a dedication to customer<br />

service, creative design and an ability to see product<br />

development opportunities and start them on a development<br />

project leading to commercialization. Responsibilities:<br />

Conceptual design and development of OEM Orthopedic<br />

products, provide technical insight and recommendations for<br />

product improvements and next generation product platforms,<br />

surveillance of existing product designs to insure competitiveness,<br />

responsible for setting and meeting Design<br />

continued on page 111


Classifieds, continued from page 110<br />

Standards utilizing CAD improvements, FEA and other design<br />

tools to insure component modularity, SKU reductions and<br />

future component cost reduction, develops initial project<br />

plans and program schedules in conjunction with the development<br />

teams, maintains thorough understanding of competitive<br />

products and their advantages and drawbacks, identifies<br />

external capabilities that are complimentary to the OEM<br />

group leading to licensing and acquisitions, creates technical<br />

articles for publications and marketing support, responsible<br />

for resource management and personnel evaluations for<br />

direct reports, works with VP of R&D and others to develop<br />

new IP, technologies and technology strategies.<br />

Requirements: BS in Engineering discipline, advanced degree<br />

preferred, 10+ years experience in creative design, hands-on<br />

and team leadership, 10+ years experience in orthopedic<br />

product development with leading physicians., Breadth of<br />

knowledge in materials and the use of CAD and FEA tools for<br />

guiding new product design and development, Outstanding<br />

interpersonal skills, customer service attitude and ability to<br />

communicate effectively with all levels internal and external<br />

to the company. Additional Information: Relocation package<br />

is available. Contact Information: jobs@teleflexmedical.com.<br />

Senior Product Development Engineer<br />

Kenosha, Wisconsin<br />

Job Description: Teleflex Medical, a world-wide surgical device<br />

manufacturer, is seeking a Sr. Product Development Engineer<br />

to join their Spine Team in Kenosha, Wisconsin.<br />

Responsibilities include: Liaison between R&D and PD and<br />

between PD and manufacturing on the development of new<br />

instruments. Use of SolidWorks (3D Modeling) to create<br />

designs and drawings. Develop new products and technologies<br />

Address customer’s issues and improve performance,<br />

appearance, and impact of product to end-user Research new<br />

materials, assembly methods, and manufacturing processes<br />

Develop design controls from initial customer request<br />

through Verification/Validation of products Initiate, process,<br />

and review Engineering Change Notices Provide support to<br />

R&D, manufacturing, marketing, and customer service; interface<br />

with customers and suppliers. Education: BSME<br />

required; BS in Biomedical or Biomechanical Engineering preferred.<br />

Work Experience: 6-10 years in product design and<br />

development of medical products. Prefer 8-10 years of product<br />

design and development in orthopedic spine instruments<br />

and/or implants. Contact Information: All qualified applicants<br />

please submit resumes and respond with #B777 in the subject<br />

of your e-mail. E-mail to jobs@teleflexmedical.com.<br />

Product Development Engineer<br />

Kenosha, Wisconsin<br />

Job Description: Responsibilities include: Design new products,<br />

perform testing and stress analysis, provide engineering<br />

support to manufacturing and marketing; interface with customers<br />

and suppliers to achieve our goal of on-time delivery<br />

111 BONEZone • Winter 2005<br />

and high quality products. Proficiency in SolidWorks to create<br />

designs and drawings and AutoCad. Requires at least 3 years<br />

orthopedic experience in Product development, design control,<br />

analysis, testing, and validation; Solidworks;. experience<br />

with forged instruments. BS in Mechanical Engineering.<br />

All qualified applicants please submit resumes and respond<br />

with #B783 in the subject of your e-mail. E-mail to:<br />

jobs@teleflexmedical.com.<br />

Exactech, Inc.<br />

Product Test Engineer<br />

Gainesville, Florida<br />

DESCRIPTION: Conduct the verification/validation testing<br />

activities of several new orthopedic implants and instrument<br />

development projects. Define and execute scientifically sound<br />

test protocols. Provide design of experiment guidance,<br />

schedule coordination and results analysis for tests that need<br />

to be conducted by outside test facilities. Apply sound engineering<br />

problem-solving techniques to facilitate product<br />

development and maintenance efforts. This includes, but is<br />

not limited to, design, analysis, material selection, and<br />

inspection requirements. Prepare and submit written and oral<br />

communications that describe product design testing and<br />

multi-project testing status. Areas of involvement include customer<br />

and sales support, regulatory submissions, Design<br />

History Files, device evaluation and testing, manufacturing or<br />

supplier support, quality control, packaging, device complaint<br />

evaluation and patent disclosures. Assure timely and<br />

effective test completion according to the project plan and<br />

budget. Review requested product tests for feasibility and<br />

scientific validity. Approve test reports for accuracy and completeness.<br />

Participate in product design review meetings.<br />

Procure and evaluate necessary test equipment. Provide<br />

product development engineers with advice on how to establish<br />

appropriate test plans for their products (i.e. design of<br />

experiment, define tasks, dependencies, schedule and<br />

resource requirements). Assist in the resolution of manufacturing-<br />

or quality-related issues. Participate in the establishment<br />

of product development goals, project plans and<br />

resource requirements. Play a key role in setting product-testing<br />

strategies for new product development. Study and recommend<br />

improvements to existing product testing protocols<br />

and types. This entails staying “up to date” on emerging<br />

material and medical product testing technologies. This may<br />

be accomplished by attending seminars, classes, professional<br />

standard societies and industry meetings. Please submit a<br />

cover letter, resume and salary history in MS Word format to<br />

robyn.szabo@exac.com. Our website is www.exac.com.<br />

continued on page 114


Announcing .<br />

OMTEC <strong>2006</strong><br />

"For my purpose, your show was far more interesting than the<br />

MD&M show—which I will no longer attend."<br />

-post-event feedback from a Director of Materials Management<br />

at one of our industry's leading OEMs.<br />

<strong>The</strong> 2nd Annual<br />

Orthopaedic Manufacturing & Technology<br />

Exposition and Conference<br />

June 21-22, <strong>2006</strong><br />

Donald E. Stephens Convention Center,<br />

Rosemont, Illinois USA<br />

This show is not open to the public. A unique conference exclusively for<br />

OEM Buyers including Materials Managers, Purchasing Agents,<br />

Buyers/Planners and Engineers. Only Exhibitors and OEM Buyers<br />

will be admitted. Non-exhibiting suppliers will not be badged.<br />

visit www.orthosupplier.com or<br />

See Registration Form at page 114


PRESS RELEASE<br />

Second Annual Orthopaedic Manufacturing Technology Exposition &<br />

Conference (OMTEC) to be Held June <strong>2006</strong><br />

CHAGRIN FALLS, Ohio, Dec. 1 /PRNewswire/ -- OMTEC <strong>2006</strong> is the world’s only event focused<br />

upon meeting the strategic sourcing needs of the orthopaedic industry’s OEM buyers. Sponsored by <strong>The</strong><br />

Institute for Orthopaedics(TM), the event will be held June 21-22, <strong>2006</strong> at the Donald E. Stephens<br />

Convention Center in Rosemont, Illinois.<br />

“OMTEC is the only orthopaedic-specific platform offering face-to-face interaction between OEM<br />

buyers and third-party providers of products and services,” commented Jack Detweiler, Vice President of<br />

Business Development for Knowledge Enterprises. “For those with buying, planning, engineering, manufacturing,<br />

or other sourcing responsibilities, OMTEC stands uniquely focused to address their needs and<br />

interests.”<br />

<strong>The</strong> conference agenda will feature educational sessions covering biomaterials, offshore sourcing,<br />

machinery and manufacturing solutions, strategies for supply chain success and more. Exhibitors will include<br />

providers of contract manufacturing services, raw materials, machinery and equipment, coatings and other<br />

surface treatments, as well as consultants that offer product design and development services such as engineering,<br />

testing and analysis. <strong>The</strong> exhibit floor will not be open to the public. Only exhibitors and OEM buyers<br />

will be permitted. Exhibiting companies include:<br />

Accutek Testing Laboratory -- Acme Manufacturing -- Bolt Industries -- Branson Ultrasonics Corp. -- Britton-<br />

Gallagher -- Criterion Instrument -- Cutting Solutions -- Design Standards Corporation -- Doncasters<br />

Medical Technologies -- DOT GmbH -- Electrolizing Corporation of Ohio -- Ensinger -- Gauthier<br />

Biomedical -- Handy & Harman -- Holmed Corporation -- IonBond-Medthin Medical -- Kays Engineering<br />

-- MACDEE -- MAHE Medical -- Marox Corporation -- McLean Medical & Scientific -- MedicineLodge --<br />

Medin Corporation -- MediTECH Poly Hi Solidur -- Metal Craft Machine & Engineering -- Millstone<br />

Medical Outsourcing -- NEMCOMED -- New Concepts Prototyping -- Oberg Industries -- Onyx Medical<br />

Corporation -- PAK Orthopaedics -- Paragon Medical -- Pinnacle Technologies -- Precimed -- Precision Metal<br />

Products -- Precision Technology -- Quintus Composites -- Richter Precision -- Schutte TGM -- Southeastern<br />

Technology -- Specialized Medical Devices -- Spire Biomedical -- Stealth Medical Technologies -- Tecomet --<br />

Teleflex Medical OEM -- <strong>The</strong> MedTech Group -- Tornos Technologies -- Unique Design/Unique Instruments<br />

-- Vulcanium Metals


Classifieds, continued from page 111<br />

Stealth Medical Technologies<br />

Quality Control Manager<br />

Holt, Michigan<br />

Stealth is part of a growing and expanding organization. If<br />

you want to be part of an exciting and innovative company,<br />

this may be the position for you. We are seeking an experienced<br />

QC Manager to head QC operations at our Holt,<br />

Michigan location. You will be responsible for in-process<br />

inspection, non-destructive testing and final audit of forged<br />

medical devices (human implants). This position has three<br />

direct reports (supervisors) and will focus on managing quality<br />

goals for the company, determining inspection criteria for<br />

all products, participating in the new product development<br />

team, evaluating and implementing corrective action, and<br />

quality engineering (product & process validations). This full<br />

time position includes base salary, annual performance<br />

bonus, insurances, vacation, 401(k) plan, etc. View our website<br />

at www.stealth-medical.com. Send resume and salary history<br />

to HR@orchid-orthopedics.com.<br />

Tornier<br />

Product Manager<br />

Houston, Texas<br />

Qualifications include 3-5 years of successful marketing experience<br />

in the orthopaedic joint reconstruction field, or product<br />

management experience. Knowledge of the U.S. medical<br />

device marketplace and has demonstrated progressive levels<br />

of accomplishment, experience in the commercialization and<br />

promotion of new products. Ability to travel extensively and<br />

must have excellent presentation, communication and organizational<br />

skills. Responsible for supporting company’s U.S.<br />

marketing effort for a specific Tornier product line. Develop,<br />

coordinate and support the implementation of marketing<br />

plans, which involves product development, technical sales<br />

support and the development medical education training<br />

materials. Education: Bachelors degree or other equivalent<br />

advanced education qualification. Responsibilities include<br />

but are not limited to: Responsible for maximizing surgeon<br />

acceptance and market penetration of Tornier related products;<br />

Establish marketing goals and execute comprehensive<br />

brand strategy to ensure share of market; Coordinate the<br />

work of product specialists in such activities as product promotion,<br />

sales training and product up-dates; Forecast customer<br />

demand and participate in review of sales forecasts for<br />

the various Tornier products; Provide product leadership,<br />

technical support and medical education to the sales field<br />

distribution network; Ensures effective control of marketing<br />

results and that corrective action takes place to be certain<br />

that the achievement of marketing objectives are within designated<br />

budgets; Perform market and competitive product<br />

analysis; Develop working relations with leading orthopedic<br />

surgeons and staff to analyze their needs and maintain a dialog<br />

for current information; Communicate product related<br />

114 BONEZone • Winter 2005<br />

sales support information to the field sales force in the form<br />

of Product Updates and other documents, Assist sales in the<br />

management of field inventory, Support the selling activities<br />

through field training, field visits and case coverage, etc.;<br />

Support the advertising and promotion activities for assigned<br />

product(s); Interact with sales force and surgeon customers<br />

to develop in depth product market knowledge in order to<br />

anticipate market changes and trends and to seek new ideas<br />

for improvement of existing products and new products;<br />

Contribute ideas and offer solutions to critical market issues;<br />

Plan and forecast product sample inventory. <strong>The</strong> Product<br />

Manager will be based in Houston, Texas and will report<br />

directly to the Vice President of Marketing. Evaluation of performance<br />

will be reviewed on a quarterly basis. Company<br />

offers competitive compensation and benefits packages.<br />

Please e-mail a resume along with a cover letter to:<br />

HR@tornier.com.<br />

For the<br />

most current<br />

orthopaedic employment<br />

opportunities,<br />

please visit<br />

www.OrthoCareers.com.


(We wanted to say we go the extra mile, but we let our<br />

engineers write the headline.)<br />

When it comes to getting your product to market<br />

quickly, every detail matters, down to the micron.<br />

With Total Solutions ® we help with everything from<br />

small projects to complete sets, co-development, design,<br />

logistics – whatever you need. All this means you save<br />

time and money.<br />

This is Total Solutions. ®<br />

And it’s only from Symmetry Medical.<br />

www.symmetrymedical.com<br />

Total Solutions® is a registered trademark of Symmetry Medical Inc. Printed in USA © 2005 Symmetry Medical Inc. All rights reserved.


HOOK HOLDERS • RONGEURS • DISTRACTORS • INSERTERS • REDUCERS • TIGHTENERS<br />

C O M P R E S S O R S • R E M O V E R S • S C I S S O R S • E L E V A T O R S • C U R E T T E S • R O C K E R S • O P E N E R S<br />

SPINAL<br />

INSTRUMENTS<br />

PAK MANUFACTURING has been serving satisfied customers in<br />

the orthopaedic market for more than five years. Our style of<br />

superior service and responsiveness has made us a leading factor<br />

in the production of custom and specialty instruments, with well<br />

over 30 active customers. Having our own facilities and equipment<br />

right here in the USA has allowed us to distinguish ourselves by<br />

offering and performing to highly aggressive lead-time<br />

commitments while maintaining superior quality and competitive<br />

pricing. We understand your needs, let us be your instrument<br />

partner!<br />

"Manufacturers of custom and specialty<br />

hand held orthopaedic instruments from forgings"<br />

• Experienced manufacturer of all custom spinal<br />

instruments including cervical, thoraco-lumbar<br />

and disc replacement<br />

• Design help provided to yield optimal<br />

ergonomics and performance<br />

• Forging-based production insures highest<br />

value and aggressive lead times<br />

• US manufactured in our own 30,000 square<br />

foot facility<br />

704 South 21st Street, Irvington, NJ 07111<br />

Tel (973) 372-1090<br />

Fax (973) 372-1091<br />

Email info@pakmanufacturing.com<br />

Website www.pakmanufacturing.com<br />

Call today, and consult with an owner: Peter Wester, Peter Scranton or Alex Even-Esh.<br />

• Unmatched responsiveness!<br />

Made in USA<br />

©2003 PAK Manufacturing, Inc. All Rights Reserved.<br />

CALIPERS • PLATE INSTRUMENTS • ROD INSTRUMENTS • DOUBLE ACTION<br />

BENDERS • CUTTERS • CONNECTORS • FORCEPS • PROBES • GUIDES • RETRACTORS • SPREADERS

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