The 2006 Supplier Directory - Orthoworld
The 2006 Supplier Directory - Orthoworld
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
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MANUFACTURERS OF ORTHOPAEDIC SURGICAL CUTTING TOOLS<br />
& PRECISION INSTRUMENTATION<br />
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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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We have been manufacturing<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
▲ ▲ ▲ ▲ ▲ ▲ ▲ ▲ ▲ ▲ ▲<br />
Concurrent engineering<br />
Precision machining<br />
Electropolishing<br />
Titanium anodizing<br />
Passivation<br />
Laser marking<br />
Assembly and test<br />
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.
Ortho FactBook<br />
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charges, etc. in an easy-to-navigate binder format.<br />
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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