Plastics for Orthopedic and Medical Applications - omtec

Welcome LetterThank you for choosing OMTEC!Our mission is to provide access to the intelligence, theexpertise, the companies and the people that will helpyou overcome your most critical challenges, identify themost lucrative opportunities and excel. A crucial componentof that mission is weeding out the hype and thefluff.Use the pages of this program to prioritize your boothvisits and educational sessions. Note that several complimentarymeals and snacks alleviate the need to burntime and dollars trekking down the street or acrosstown. We have also added a business center to furtherenhance your show floor productivity. A new poster/display area houses current musculoskeletal-specificresearch projects. The Welcome Reception on Wednesdayafternoon in the Exhibit Hall affords targeted networkingtime…previous attendees will affirm, businessgets done, so please plan to attend.Table Of ContentsSchedule Of Events...................... 4Floor Plan...................................... 6Keynote Addresses...................... 8Lectures & Workshops................ 9Exhibitor Listing..........................16Index Of ExhibitorsBy Capability..........................44Attendee Resources..................46We encourage you to grab any of us during the conferencefor assistance of any kind. Our team is alwayspresent in the ORTHOWORLD booth or the registrationarea. Don’t waste a moment wondering if we mightknow or be able to help…just ask. We are honored to beof service to you.We know this to be certain:Education fuels knowledge.Networking builds relationships.The right people with the right knowledge and skillsnet us increased levels of performance and success.These fundamentals are promoted at OMTEC to guideyou and your business to prosperity during times of uncertaintyand change.Thank you again for choosing OMTEC. We are committedto delivering return on your investment. On behalfof the entire ORTHOWORLD team, we wish you a productiveand enlightening meeting. Onward!Best regards,April C. BrightGeneral ManagerORTHOWORLD, Inc.Page 3

Schedule Of EventsWednesday June 158:00 AM Breakfast Keynote Address: Room 51 - Hospital + Surgeon: YourChanging Customer Marshall Steele, M.D., Marshall Steele & AssociatesBreakfast Served at 7:30 AMSponsored by Bradshaw Medical9:00 AM Exhibit Hall Opens9:00 - 10:00 AM Coffee Break Served in Exhibit Hall, Sponsored by JPMC10:30 AM Educational Sessions BeginLecture10:30 a.m. - 12:00 p.m.Planning For and ManagingFDA Inspections:Logistics/ProcessArchitecture/QSITJohn Gagliardi, MidWestProcess InnovationLecture10:30 a.m. - 11:30 a.m.Getting Started with CEMarking: Your Passport toEuropeSuzanne Halliday, Ph.D.,BSI GroupLecture10:30 a.m. - 12:00 p.m.Supply Chain Management:Lessons LearnedMahender Singh, Ph.D.,Massachusetts Institute ofTechnologyLecture10:30 a.m. - 12:00 p.m.High Performance MedicalPlasticsMaria Gallahue-Worl,Solvay Advanced Polymers12:00-1:30 PM Luncheon Served in Exhibit Hall, Sponsored by RochlingWorkshop1:30 p.m. - 3:45 p.m.Planning For and ManagingFDA Inspections: WorkingWith Actual Scenarios fromFDA InspectionsJohn Gagliardi, MidWestProcess InnovationLecture1:30 p.m. - 2:30 p.m.The Fundamentals ofReimbursement:Understanding HowCoverage, Coding andPayment Impact a MedicalTechnologyKelli Hallas, EmersonConsultantsLecture1:30 p.m. - 3:00 p.m.Advanced MechanicalInspection: How to MakeInspection Better, Fasterand More Cost-EffectiveKelly Lucenti, MillstoneMedical OutsourcingWorkshop1:30 p.m. - 3:45 p.m.Sales & OperationsPlanning: The Basics andBeyondTom Wallace, T.F. Wallace& Company2:00-2:30 PM Refreshments Served In Exhibit Hall, Sponsored by Onyx Medical2:00-2:30 PM Poster Presentation In Exhibit Hall: Cartilage-on-Cartilage articulatingsystem as a wear benchmark for artificial replacement systemsWorkshop Cont.Discussion Panel3:00 p.m. - 4:00 p.m.Best Practices inOEM/Supplier Relationships:Getting the MostValue from the SupplierPerspectiveLecture Cont.Workshop Cont.4:00-5:30 PM Reception in Exhibit Hall, Sponsored by Greatbatch Medical5:30 PM Exhibit Hall ClosesPage 4

Schedule Of EventsThursday June 168:00 AM Breakfast Keynote Address: Room 51 - The Global Orthopaedic Industry:A High Altitude ViewDon Urbanowicz, Urbanowicz Consulting, LLCBreakfast Served at 7:30 AMSponsored by Orchid Orthopedic Solutions9:00 AM Exhibit Hall Opens10:00 AM Educational Sessions BeginLecture10:00 a.m. - 11:00 a.m.Clinical Evaluation 101: AKey Requirement to GainingAccess to the EuropeanMarketSuzanne Halliday, Ph.D.,BSI GroupLecture10:00 a.m. - 11:30 a.m.The Secret to a SuccessfulProduct Launch: TheIntegration of Reimbursement,Clinical, Regulatoryand Marketing StrategiesKelli Hallas, EmersonConsultantsLecture10:00 a.m. - 11:30 a.m.Orthopaedic Biomaterials:Using History to InformInnovationAyyana Chakravartula,Ph.D., Exponent FailureAnalysis AssociatesAdditionalEducation TBA.11:30 PM Luncheon Served in Exhibit Hall2:00-2:30 PM Poster Presentation In Exhibit Hall:Optimized follower load system for lumbar spine flexion/extension testingLecture1:00 p.m. - 2:00 p.m.Vesting for Success: TenMust Have Elements for aSuccessful Business SupplierAgreementKate Vitasek, University ofTennesseeWorkshop1:00 p.m. - 2:30 p.m.The Toolbox for HighSpeed Innovation andNew ProductDevelopmentGreg Githens, PMP, NPDP,Catalyst ManagementConsultingLecture1:00 p.m. - 2:00 p.m.The View from Washington:What Device MakersNeed to Know aboutFDA’s Latest Priorities andInitiativesMartin Browning,EduQuest, Inc.Exhibitor & AttendeeFeedback Session3:00 p.m. - 4:00 p.m.Open Invitation to allOMTEC participants toshare any and allfeedback.3:00 PM ADJOURN - BREAKDOWN EXHIBIT HALLPlease reference pages 8-15 in the Final program for speaker bios and session abstracts.Many presentations and handouts are available for download at www.omtecexpo.com.You can make use of this resource immediately, or look for an email notification following the event.Follow OMTEC on Twitter: @OMTEC_2011Page 5

Floor PlanHALL GDonald E. Stephens Convention CenterJune 15-16, 2011Shaded booths indicateevent sponsors.New EntranceLocationMAIN ENTRANCEFH126124140CentexMachiningParagonMedicalPulseTechnologies142CamBioceramics245AisleAisle100 200127 226BradshawMedical125EnsingerC&A ToolEngineering224246-247Greatbatch MedicalPrecisionMetalProductsPartmaker227225BARCarpenterTechnologySurfaceDynamicsAisle300326JarvisSurgical324TitaniumIndustries122PCCStructurals120121220221320MAINENTRANCEForecreuAmerica118PacificInstruments116AmericanTool & Die114LAB MedicalManufacturing112RolledAlloysTegraMedical119UnitedOrthopedic115Trigon113rose plasticUSA218EmersonConsultants214MarketWire212Millstone RochlingMedical EngineeringOutsourcing PlasticsXTornosXX215CurbellPlastics213ZOLLERHangsterfer'sLaboratories318Triangle314VulcaniumMetals312MedinREGISTRATIONXXXXXXXXXXXXXX XXDESKBAR109-208209 308Juno Pro-Dex HoosierNew BusinessCenterConcession100 101 102Level 3InspectionSAYANOrthopaedicsElectropolishingSystemsEmailStationXXXENTRANCEPage 6

Floor Plan345 346 442-443AutocamMedicalMediTECHMedicalPolymersSoutheasternTechnologyCafe331-333OrchidOrthopedicSolutions327325Oak ViewTool321Rollomatic319GibraltarLaboratories315Esprit/DPTechnology313Orthoplastics432 433PMCMedical430Aeromed426SeabrookInternationalNew-ScienceInsurance424AIP420PrecisionPiece Parts418SolvaySpecialtyPolymers414CaPBiomaterials412SupraAlloysAisle400OnyxMedicalX425-427421XX415413XMaroxDonsonMachineXX532530526524520ASTROMedicalDevices518IonBond514FMI Medical Fort WayneInstruments MetalsMahar ToolArcamIn'TechMedicalAdvantageManufacturingTechnologiesMicrowarePrecision512Makino533TeleflexMedicalOEM531EndoManufacturingAisleAisleAisleAisle500 600700800527 626 627 726 727 826TotalPlastics525RTIInternational519-521RoslerMetal515BrownPrecision513MedivativeTechnologies632NormanNoble630PromimicBob, Inc.624BoedekerPlastics620PiperPlastics618gSource614SHL612TEScoAssociates633AcmeManufacturing631MinnesotaRubber &PlasticsNeedleTechProducts625InternationalTitaniumAssociation621BritishStandardsInstitute619 718 719FairviewMachine615InfinityPlastics613PraxisTechnology732Walter, aUnitedGrindingCompany730OTECPrecisionFinishingTwin CityEDM724ProfessionalPlastics720AllianceGlobalTechnologyPacificAmericanMedicalService714UniversalPrecision712Bodycote733FinishingInnovations731 830CanwellMedicalTeroLabSurface725KensFineMedtech721NSEAutomatechAmericanExpressOpen715AccelLAB713ElectrolizingCorp ofOhio832APSMaterialsDurrEcocleanMicroMachine824820818814812SonoscanEmailStation825-827OkumaAmericaXX821813XTenergy815-819RichardsMicroToolRestrooms309SS WhiteMedical408HansaMedical409Tecomet508PAKManufacturing509Metal Craft608DeloroStellite609GEHRINGCUT708VistekMedicalBAR200 201 402 500-501 502 600 601KnightMechanicalTestingAvalignTechnologiesEptamPlasticsBranch Medical Maetta PPDMeditechDexcowin602ArwoodMachineSTAGEEntrance to Educational SessionsNew White PapersSession AreaPage 7

Keynote Addresses8:00 a.m., Wednesday June 15Keynote: Hospital + Surgeon:Your Changing CustomerMarshall Steele, M.D.Chief Executive OfficerMarshall Steele & AssociatesThe business climate for device manufacturers is rapidly changing.No longer is the surgeon the only customer. Physicians and hospitalsare increasingly finding ways to align their incentives, and hospitalsand physicians are beginning to speak with one voice. In thefuture, vendors may have many customers: the partnership of thehospital and the surgeon, patients, group purchasing organizationsand even the payers themselves.New device manufacturers are springing up that will providegeneric versions of our current implants at half the cost. Establisheddevice manufacturers have a choice: Do they just focuson the technical aspects of their products? Do they compete onprice? Do they partner with hospitals, surgeons, patients andinsurers in a new and different way?Transparency is quickly emerging caused by patients, physicians,insurers and hospitals. Medical device companies will need tocollect outcomes on their products in the hands of all users, notjust the elite few. This trend creates both concern as well as opportunityfor medical device companies. They must become partners,not suppliers. They must create value for all stakeholders andwork with them to improve healthcare from a quality perspective,and an economic one, as well. Woe to those that persist in theold economic model.We will discuss why these trends are occurring, how fast theywill occur and what device manufacturers should consider doingto face all new challenges.Dr. Marshall Steele is a board certified orthopaedic surgeon,founder and Chief Executive Officer of Marshall Steele & Associates,a firm that implements musculoskeletal service lines andprograms in hospitals. The firm creates Destination Centers inorthopaedics and spine, provides data collection tools for bothpatient- and hospital-reported outcomes and a nascent nationalregistry for benchmarking and best practices.Dr. Steele started his orthopaedic practice in 1977 as a solopractitioner and grew it to 16 sub-specialized orthopaedic surgeons.Between 1996 and 2005, he also served as the MedicalDirector of Surgical Business Development at Anne ArundelMedical Center in Annapolis, Maryland. He was instrumentalin helping to develop many very successful specialty surgicalprograms that have received national attention.He has received numerous awards, including the Pascal Awardfor Youth Sports, The Leadership Award given by his peers,and was recently inducted into the Anne Arundel County BusinessHall of Fame. Dr. Steele has long been passionate aboutdefining, measuring and improving quality. His most recentbook is Orthopedics and Spine, Service Line Strategies for SuperiorPerformance (Healthleaders 2009).8:00 a.m., Thursday June 16Keynote: The Global OrthopaedicIndustry: A High Altitude ViewDon UrbanowiczPrincipalUrbanowicz Consulting, LLCDon will provide a high altitude view of the global orthopaedicindustry, including the resultant opportunities and issues expectedto be encountered over the next five years.His presentation will include an overview of worldwide marketgrowth and competition, and a discussion of the resultant impactof post-recession, post-reform and the current FDA climate onmedical device companies (and each of their key departments,including marketing, product development, regulatory, reimbursement,operations and quality), hospitals, surgeons, patientsand payers.This session will address these specific points:• What is the state of the worldwide orthopaedic businessand its major players?• How will the recession, healthcare reform and currentFDA climate impact the variety of stakeholders?• What are the expected opportunities and risks over thenext five years?Attendees will receive these tools to put to immediate use:• Identification of relevant industry trends/opportunitiesand their impact on you and your customers• The ability to incorporate issues, trends and opportunitiesinto your strategic planning process; confirming whethereach validates, alters or completely changes your goforwardstrategy• Identification of new skills or processes that you and/oryour team may need to develop and implementUrbanowicz Consulting, LLC (UC) is a medical device advisoryfirm with a musculoskeletal focus, seeking to enable prospectiveclients to achieve their strategic and transaction-related goals bycapitalizing on market opportunities.Don Urbanowicz, UC’s principal, has a 30-year track record inthe healthcare industry, with a deal-making focus over the pastten years. Don has held prior senior management/leadership positionsat Stryker, Smith & Nephew, Sofamor Danek and Aircast.He has successfully developed and implemented strategic planningand business development transaction life cycle processes.He has also successfully concluded numerous pre-revenue andbolt-on transactions, many of which were outside the U.S. Donhas a deep understanding of how strategics think about, approachand place value on potential transactions.Page 8

Lectures and WorkshopsLecture: The View fromWashington: What Device MakersNeed to Know about FDA’s LatestPriorities and InitiativesMartin BrowningPresident and Co-FounderEduQuest, Inc.Martin Browning, co-author of the original 21 CFR Part 11, aformer field investigator and senior executive in FDA’s Officeof Regulatory Affairs, will help you review your operationsto better align them with FDA expectations. Included willbe scrutiny of the highly volatile issue of orthopaedic deviceaccessories and tools that cumulatively trigger a huge numberof MDRs and recalls. Martin will also discuss FDA’s heightenedconcerns for more vigorous, ongoing supplier evaluations.These specific points will be addressed:• FDA’s top concerns about orthopaedic devicemanufacturers• Enforcement targets and priorities for 2011 and beyond• Potential minefields for device makers: accessories andtools• Latest FDA and international expectations for supplierselection and controls• Lessons learned from internal audits of facilities inseven different countriesAttendees will receive these specific tools to put to immediateuse:• Actionable list of FDA “hot button” issues• EduQuest Advisory Report on “The Hot Potato ofResponsibility: How to Manage Outsourcing and NotGet Burned”• Free subscription to EduQuest-ions & Answers, a monthlyQ&A with FDA compliance professionals at EduQuestMartin Browning is the President and Co-Founder of EduQuest,Inc., a global team of FDA compliance experts based nearWashington, D.C. Martin has more than 30 years of regulatoryexperience at FDA and as a highly sought-after advisor toindustry. His 22-year career at FDA included work as aninvestigator and as a senior manager in the Office of RegulatoryAffairs at FDA headquarters. At EduQuest, Martin helps clientssolve problems related to FDA regulation, quality assurance,software and systems engineering and compliance auditing,including the assessment of vendors and outsourced operations.Page 9

Lectures and WorkshopsLecture: OrthopaedicBiomaterials: Using History toInform InnovationAyyana Chakravartula, Ph.D.AssociateExponent Failure Analysis AssociatesThis lecture gives the history of orthopaedic biomaterials, withfocus on development trajectory. Materials used in orthopaedicimplants will be examined in the context of those from otherdevice fields, with areas for future exploration highlighted.Recent developments in biomaterials processing and regulatoryaffairs will also be covered.These specific points will be addressed:• History shows that orthopaedic biomaterial developmenthas advanced in large steps vs. other medicaldevice fields.• The current state of regulatory affairs is not favorable tochanges.Attendees will receive these specific tools to put to immediateuse:• Perspective on past failures and successes in orthopaedicbiomaterials• Developments in other medical device fields that caninform R&D in orthopaedics• A summary of the regulatory path for commonorthopaedic devicesDr. Chakravartula has particular expertise in the mechanicsof biomaterials. Her research has addressed composition,manufacture and performance of natural and syntheticmaterials used in biomedical applications, including cartilage,hydrogels and polyethylene. She has experience with the FDAregulatory process and with test development and validation forbiomaterials.Prior to joining Exponent, Dr. Chakravartula worked asa research scientist at Cambridge Polymer Group. Sheserved as an adjunct lecturer at Boston University, teachingan undergraduate-level course entitled “Mechanics ofBiomaterials,” and co-authored an undergraduate textbook bythe same name.Lecture and Workshop:Planning For and Managing FDAInspectionsJohn GagliardiPresidentMidWest Process Innovation, LLCPlanning for and Managing FDA Inspections• 1.5-hour introduction and lecture in the morning• 2-hour workshop in the afternoon of the same dayLearn how to develop and implement a coherent strategy andprocedure for managing and documenting FDA inspections. Aplanned, pre-meditated approach will be of critical importancewhen the Notice of Inspection form, FDA-482, is presented.These specific points will be addressed:Part I (Lecture), Logistics/Using Process Architecture/QSIT• Preparing/Designating an Inspection Team• Limiting Missteps/Managing the Closeout Meeting• Responding to an FDA 483Part II (Workshop), Working with Actual Inspection Scenarios• Choosing the appropriate objective evidence• Planning for and then answering the questions• Scenarios: FDA “hot buttons”Attendees will receive these tools to put to immediate use:• Effective preparation and behavior strategies formanaging an FDA inspection• Knowledge of potential scenarios and responsestrategiesMr. Gagliardi’s successful 40-year track record in the MedicalDevice and Pharmaceutical industries stems from his practicalapproach to process-orientation and business. He has been activelyinvolved in research and development, quality assurance,training, operations, process architecture, FDA inspections andregulatory affairs. John specializes in building systems in a compliantand business-ready manner.Lecture: High PerformanceMedical PlasticsMaria Gallahue-WorlGlobal Business Manager - HealthcareSolvay Specialty PolymersThis session will address the replacement of metal by high performanceplastic in the healthcare industry, following trends andmaterials selection, design considerations and examples.The following specific points will be covered:• Trends in the healthcare industry affecting materialselection for instruments and devices• Metal replacement by high performance plastic: keyconsiderations for material selection• Examples and case studiesMaria Gallahue is the Global Business Manager – Healthcare forSolvay Specialty Polymers, a leading global supplier of high-performancethermoplastics based in Alpharetta, Georgia. Maria’s18-year career in the polymer industry spans activities includingproduct and business management, marketing, manufacturing,quality control and design engineering. Maria has a long historyof identifying and achieving cost reduction for customersin a wide range of metal replacement projects. Maria has been amember of the Society of Plastics Engineers since 2002.Workshop: The Toolbox forHigh Speed Innovation and NewProduct DevelopmentGregory D. Githens, PMP, NPDPManaging PartnerCatalyst Management Consulting LLCPage 10

Orthopaedic, Trauma, CMF, and Spinal ImplantsNet Shape & Closed Die ForgingNet & Near Net Shape Forging | Closed Die Forging | Upset ForgingMechanical and Screw Presses from 700 to 1600 TonsTool Design and FabricationConventional & CNC Machining4 & 5-Axis CNC Milling | 8-Axis CNC Mill/Turn CentersHigh Speed Hard Die Milling | Wire EDMSinker/Plunger/Ram EDM | Swiss Machining | HoningGrinding | Conventional MachiningPhotochemical MachiningAutomated 2D Etching Lines3D Etching Line for Complex ShapesPhoto Tool Design and FabricationAutomated Laser Feature InspectionLaser & E-Beam Weldingand Vacuum BrazingVacuum Brazing with Helium Backfill | Electron Beam WeldingLaser Welding (4 Axis) | Sintering | Diffusion BondingPressure, Leak, and Flow TestingCustom FinishingCleaning | Passivation | Alpha Case Removal | BeltingTumbling | Grit Blasting | Heat Treating | Laser Marking“Hi Bright” Polishing | High Speed Centrifugal Disk FinishingLaunchQuick Rapid PrototypingFunctional prototyping from concept sketches or modelsDedicated multi-axis CNC machining centersFull range of support for machining, finishing and inspectionISO 9001:2000 | ISO 13485 | FDA RegisteredA Leader in Net Shape Forging,Precision Machining, Photochemical Etchingand Joining of Critical Components115 Eames Street | Wilmington, MA 01887Phone: 978 642 2400 | Toll Free: 888 287 0400sales@tecomet.com | www.tecomet.com

Lectures and WorkshopsThis session will provide useful practices for improving thespeed and effectiveness of innovation programs. It draws fromintensive study of strategic initiatives and new product launches.Effectiveness is found by focusing on four general areas:• Tools for fast and effective decisions• Tools for recognizing and managing uncertainty andambiguity• Tools for integrating programs, products, portfolios andpeople• Tools for creating alignment and commitmentGreg Githens possesses over 25 years of experience in strategicprograms and innovation. He is skilled at building alignment inpeople that enables them to get the tough work done. A recognizedauthority, Greg has spoken to many high-profile groupsand authored over three dozen articles, papers and books on thetopic. Greg holds advanced degrees in business and science, andis a certified Project Management Professional and a certifiedNew Product Development Professional.Lectures: The Fundamentals ofReimbursement: UnderstandingHow Coverage, Coding andPayment Impact a MedicalTechnologyThe Secret to a SuccessfulProduct Launch: The Integration of theReimbursement, Clinical, Regulatory andMarketing StrategiesKelli HallasExecutive Vice President, Reimbursement ServicesEmerson ConsultantsLecture #1: The Fundamentals of Reimbursement: Understandinghow Coverage, Coding and Payment Impact a Medical TechnologyThis presentation will discuss:• The three drivers of reimbursement: coverage, codingand payment• How reimbursement impacts a technology• The importance of well designed clinical studies anddata to reimbursement• Key reimbursement questions to ask yourself pertinentto your medical technologyAttendees will actively participate in creating a reimbursement“Top Ten Checklist” for incorporation into strategic plans.Lecture #2: The Secret to a Successful Product Launch: The Integrationof the Reimbursement, Clinical, Regulatory and MarketingStrategiesThis presentation will discuss:• Why it is critical to integrate strategies early• How to integrate four completely unique strategies• How successful integration will impact your business• When and what to integrate in the processAttendees will create a “blueprint” that will identify strategicinitiatives by product phase for incorporation into product strategicplans.Kelli Hallas joined Emerson Consultants in 2004 as Vice Presidentof Reimbursement Services. She focuses on developing andimplementing strategic initiatives to remove reimbursement obstaclesand drive business at all stakeholder levels.Kelli is a tenured professional with 20 years of medical technologyexperience. She has experience providing a range of servicesto hospitals, physicians, payers and medical technology companies.Her expertise includes IDE clinical trial reimbursement,financial modeling tools for products and procedures, healthcarepolicy and CMS and AHRQ focused initiatives. Kelli has securednew ICD-9 procedure codes for emerging procedures, successfullyobtained pass-through status for new technologies and biologics,partnered with professional societies for the implementationof CPT® codes and worked with local and national payersto implement coverage decisions.Kelli has been a featured presenter at industry programs and isa contributing writer in industry-related publications. She haspublished Fundamentals of Reimbursement, a reference guide onhow reimbursement impacts sales in today’s healthcare marketplace.Lectures: Getting Started With CEMarking: Your Passport to EuropeClinical Evaluation 101: A KeyRequirement to Gaining Access tothe European MarketSuzanne Halliday, Ph.D.Team Leader for Orthopaedic and Dental DevicesBSI HealthcareLecture #1: Getting Started With CE Marking: Your Passport toEuropeAre you interested in selling your orthopaedic device in the 27countries that comprise the European Union (EU)? This sessionwill help you gain a basic understanding of the CE Markingregulatory process and the Medical Device Directive (MDD) regulationsthat govern placement of products into the EU. Learnthe thinking behind the different device risk classifications andunderstand when you need a Notified Body.Learning Objectives:• Overview of the European Union marketplace• Understand the purpose and basic requirements for CEMarking• Fundamentals of risk classification and routes toconformity• Learn the relationship of quality and risk managementwith the MDD• Understand the role of a Notified Body• Identify the steps required to place a device on themarket in the EU marketPage 12

Inspiring Solutionsfor 20 Years®Orthopedic companies know that a partnership with Onyx starts with our best-in-class qualitysystems, unparalleled technical leadership and deep-seated respect for serving the industry. Thisfoundation allows us to do more than assist you with bringing new products to market—it ensuresthat together, we’re optimizing your supply chain for long-term success.We’re Onyx ... Where Ideas and Ingenuity Converge.800-238-6981 onyxmedical.net ISO 13485:2003 / FDA 1043653

Lectures and WorkshopsAccess to the EU marketplace can provide tremendous growthopportunities. It may make business sense to initiate the Europeanprocess concurrently or even prior to obtaining FDA clearance.Lecture #2: Clinical Evaluation 101: A Key Requirement toGaining Access to the European MarketAre you aware of the impact Clinical Evaluation has on placingyour Medical Device in the EU? Selling your product in Europerequires a CE Mark. This requires a device manufacturer tocomply with the European Medical Device Directive (MDD)regulations in which clinical evaluation is a key requirement.Clinical evaluation is the assessment and analysis of clinical datapertaining to a medical device in order to verify its clinical safetyand performance.Learning Objectives:• Understand the European regulatory framework• Definition of clinical data• Learn the clinical evaluation process• How the scope of data required is proportional to therisk of the device• Obtain a listing of useful resourcesDr. Suzanne Halliday is the Team Leader for Orthopaedic andDental devices within BSI Healthcare. She oversees a team ofproduct experts responsible for EN ISO 13485 and CE Markingfor 175+ clients globally, along with numerous Mutual RecognitionAgreements for compliance in Canada, the U.S., Japan,Taiwan and Australia. Dr. Halliday holds a Masters in Sciencefrom the University of Waterloo and a Doctorate in Design Engineeringfrom University of Oxford. She has designed joint replacementimplants, spinal and fracture fixation systems and hasconducted post market clinical investigations.Lecture: Advanced MechanicalInspection: How to MakeInspection Better, Faster andMore Cost-EffectiveKelly LucentiPresidentMillstone Medical Outsourcing LLCMedical device manufacturers are paying close attention tomechanical inspection. A quality issue could lead to a recall,but time-consuming bottlenecks raise concerns for growingcompanies, as well. Whether an OEM’s mechanical inspectioncell is managed in-house or outsourced, this session will offertechniques to evaluate, strengthen and enhance mechanicalinspection capabilities.Attendees will learn:• The biggest inspection pitfalls and how to avoid them• Innovative practices for enhancing mechanical inspection• Requirements – from equipment to protocols to training –for Best in Class mechanical inspectionSession attendees will leave with:• Check list for evaluating existing mechanical inspectionprocesses in-house or outsourced• Ideas on how to reduce time required for mechanical inspection• Information about qualifying an outsourcing partner• Tips on gaining the most from an outsourcing relationshipKelly Lucenti is President of Millstone Medical Outsourcing.Before becoming President, he was responsible for developingand directing Millstone’s quality systems as Vice President ofQuality. Prior to joining Millstone, Mr. Lucenti was Director ofWorldwide Operations for Flexcon Industries and served in avariety of capacities in the Orthopaedics and Codman divisionsof Johnson & Johnson. He received a Bachelor of Science degreein Industrial Engineering and Operations Research from TheUniversity of Massachusetts at Amherst, and a Doctorate of Lawfrom Southern New England School of Law.Lecture: Supply ChainManagement: Lessons LearnedMahender Singh, Ph.D.Research DirectorMIT Supply Chain 2020 ProjectThe U.S. healthcare system is undergoing a dramatictransformation. How this will affect various sectors andpractices is essentially unknown. In such a situation, it is importantthat players pay greater attention to their strategies andstrive to shape the future. Strategy is a choice and should reflectthe desires and capabilities of the organization. In this presentation,we will share our learning from multiple industry projectsthat mapped and leveraged mental models of the supply chainteam.Dr. Mahender Singh is a Research Director for the MIT SupplyChain 2020 Project, a multi-year research effort looking into thefuture of logistics and supply chain management. His researchand teaching focus on operations and supply chain management,with particular interest in exploring the underlying structureof complex supply chains.Dr. Singh has over ten years of experience in the field of supplychain management and has worked on multiple global supplychain projects to analyze and redesign planning systems. He hastaught Operations Management at the University of Tennessee,Knoxville, where he received his Ph.D.; he is also a graduate ofMIT-CTL’s Master of Engineering in Logistics Program.Lecture: Vesting for Success:Ten Must-Have Elements for aSuccessful Business SupplierAgreementKate VitasekUniversity of TennesseeThis session will address:• How an outsourcing agreement differs from a contractfor goods• Why it is important to have a “vested” agreement• The elements that comprise a successful businessagreementPage 14

Lectures and WorkshopsAttendees will receive these specific tools to put to immediateuse:• Decision matrix and instructions on how to map yoursourcing business model to your agreement• Checklist of ten elements of a successful agreementAuthor, educator and business consultant, Kate Vitasek is anationally recognized innovator in the practice of supply chainmanagement and outsourcing. Vitasek’s approaches and insightshave been widely published in respected academic andtrade journals. She is the co-author of the Council of SupplyChain Management Professionals’ best selling book, SupplyChain Process Standards, and has contributed to over 75 articlesand five books, including her latest book, Vested Outsourcing:Five Rules That Will Transform Outsourcing.Vitasek is a faculty member at the Univ. of Tennessee’s Centerfor Executive Education and is the Founder of Supply ChainVisions, a boutique consulting firm specializing in Supply ChainManagement. Vitasek has also served on the Board of Directorsfor the Council of Supply Chain Management Professionals.Workshop: Sales & OperationsPlanning: The Basics and BeyondTom WallacePresidentT.F. Wallace & CompanyExecutive S&OP helps companies balance demand and supply;integrate financial planning with operational planning; hit financialtargets more effectively and launch new products faster andbetter.These specific points will be addressed, with time for Q&A andgroup discussion:• Part 1 will be an overview of the process, describingwhat it is and how it works.• In Part 2, we’ll cover benefits that companies haverealized from using the process.• Part 3 will focus on implementation: how to make theprocess work.• Part 4 is the segment on “beyond the basics,” oradvanced uses of the process.Tom Wallace is an author and teacher specializing in S&OP. Heis a Distinguished Fellow of the Ohio State University’s Centerfor Operational Excellence, and teaches in conjunction with theInstitute of Business Forecasting and Planning. He has taught10,000+ business people in Australia, Belgium, Canada, China,France, Great Britain, Mexico, New Zealand and the U.S.Tom has written 12 books, including Sales & Operations Planning:the How-To Handbook, 3rd Edition (2007), Sales & Operations Planning:the Executive’s Guide (2006) and Sales & Operations Planning:the Self-Audit Workbook (2005). His books have been translated intoseven languages. Tom has also produced a number of videos, mostrecently, The Education Kit for Sales & Operations Planning (2009),a multi-media teaching resource.Panel DiscussionThe Supplier Perspective: Best Practices inOEM/Supplier Relationships - Getting theMost ValueModerators: Howard Levy, Chief Procurement Officer, Biomet,Inc. and Mark Hall, Global Strategic Sourcing Manager, Smith &Nephew Orthopaedics, Inc.Panelists:Mauricio Arellano, President, Greatbatch MedicalJodie Gilmore, Vice President Strategic Business Development,Onyx MedicalMatt Burba, Executive Vice-President of Implant Manufacturingat Orchid Orthopedic SolutionsDiscourse will focus upon building and nurturing successful,prosperous relationships. A preliminary sampling of questionsposed to the panel may include:• Where are OEMs leaving value or money on the tablewhile working with suppliers?• Much emphasis has been placed on getting suppliersengaged earlier in the new product developmentprocess. What should OEMs do to make early supplierengagement more successful?• Seems like suppliers’ new technologies or newcapabilities can get overlooked in the day to dayrunning of the business. What’s the best way to tap intoyour newest technologies and innovations to ensure acompetitive advantage to a customer?OMTEC Poster PresentationsCartilage-on-cartilage articulating system as a wear benchmarkfor artificial replacement systems.Jonathan L. Stoia, 1,2 Carol A. Pacione, 2 Susanna Chubinskaya, 3Markus A. Wimmer 1,2,31Dept. of Bioengineering, University of Illinois at Chicago2Dept. of Orthopedic Surgery, Section of Tribology, Rush University Medical Center3Dept. of Biochemistry, Rush University Medical CenterMethods of articulating artificial materials in vitro against cartilageexist; however, a benchmark with which to compare theoutcome is needed. The purpose of the study was to investigatethe effects of articulating cartilage on cartilage and comparethem to metal-on-cartilage wear experiments.Optimized follower load system for lumbar spine flexion/extension testing.AbdulRahman Abutaleb, Kayla Andalina, Dean Khan, AmandaVicich, University of Illinois at ChicagoApplying a compressive load on the lumbar spine of physiologicalmagnitude in vitro has been a challenge. Improved experimentalcapabilities provided by Spinomatix, a follower loadsystem, will allow for future lumbar spine studies with deeperinsights into the lumbar spine’s support function, disorders anddegradation mechanisms.Page 15

Exhibitor Listing715. AccelLAB Inc.1635 Lionel-Bertrand BoulevardBoisbriand, QC J7H 1N8Canada450-435-9482 (phone)450-435-4795 (fax)www.accellab.comAccelLAB Inc. is a preclinical CRO that provides in life services needed toconduct high-quality product safety and efficacy studies from the proofof concept to regulatory submission in a GLP environment. Evaluationservices include study design, on-site surgeries, histology, imaging,blood assays and clinical pathology. State-of-the-art imaging modalitiesinclude MRI, whole-body CT, high-definition radiography and MicroCT. Full histopathology and histomorphometry reports are provided byexperienced veterinary pathologists.424. AIP724 Fentress BoulevardDaytona Beach, FL 32114USA386-274-5335 (phone)386-274-4746 (fax)www.aipdaytona.comAIP has 30+ years of experience machining ultra high precision complexplastic components from polymer materials such as PEEK, PEEK-OPTIMA,CF-PEEK-OPTIMA, PTFE, RADEL-PPSU, TECANYL-MT, UHMW-PE,TECAPRO-MT, ULTEM, etc. AIP boasts an impressive customer list in eachof the industries we serve, while maintaining a small, hungry companymentality to assure top notch service to all our potential and existingcustomers. ISO 9001:2008 and ISO 13485:2003 certified.633. Acme Manufacturing Company4240 North Atlantic BoulevardAuburn Hills, MI 48326USA248-393-4200 (phone)248-393-4060 (fax)www.acmemfg.comAcme Manufacturing Company720. Alliance Global Technology Co., Ltd.2F., No.92, Luke 5th RoadLuzhu Dist., Kaohsiung City 821Taiwan (R.O.C.)886-7-695-6688 (phone)886-7-695-5329 (fax)www.alliance-gt.comIntegrated Robotic Polishing, Grinding & Buffing Systems for OrthopaedicComponents. Largest global manufacturer of robotic gate grinding andfinishing systems. We focus on providing a complete, fully developed,risk-free finishing system to support the global medical implant industry.In-house technical support staff of engineers for applications, productand electrical controls, off-line programming and training. ISO 9001:2008certified.Manufacturer of orthopaedic implants and instruments, including boneplates and bone screws, surgical instruments, etc. We offer precise CNCmanufacturing skills and surface treatment of advanced medical devices.ALLIANCE is the first company to manufacture Class III medical devices inTaiwan. Our quality system is certified to ISO 13485 and Taiwan GMP. Wecooperate with experts in many fields to provide good quality products andsatisfying customer service.526. Advantage Manufacturing Technologies, Inc.14298 169th Drive SoutheastMonroe, WA 98272USA425-485-3980 (phone)425-483-1608 (fax)www.teamamt.comWe work with various metals, moving with you, incorporating every stepfrom engineering design assistance through assembly and final packaging,performing work to your exact specifications. With consistency, ourproduction and quality systems provide parts that meet your tight toleranceand specifications time after time. AMT’s exceptional team works as yoursilent partner towards the mutual success of each of our companies.719. American Express Open200 Vesey StreetNew York, NY 10285USA212-640-2000 (phone)212-640-0128 (fax)www.open.comAmerican Express® Business Cards give you automatic access to the toolsand resources that American Express OPEN sm has to offer, including benefitsthat can help you save money, gain control over your practice expenses,earn valuable rewards and much more.430. AeroMed, Inc.2342 North Penn RoadHatfield, PA 19440USA215-997-2900 (phone)215-997-0165 (fax)www.aerom.comPrecision Medical Components. AeroMed specializes in multi-axis CNCmachining, including Swiss turning and High Speed milling of componentsand assemblies. We manufacture medical devices such as orthopaedicimplants and screws, ortho-fixation and implantable devices used inmicro- and minimally invasive surgery. AeroMed provides full project andinventory management and is FDA compliant. Certified to ISO 9001:2000FM514233 and ISO 13485:2003 FM507091.116. American Tool & Die, Inc.9470 E 14 1/4 RoadManton, MI 49663USA231-824-9772 (phone) x502231-824-9790 (fax)www.americantooldie.comAmerican Tool & Die, Inc., also doing business as American Instrument &Implant, is a precision manufacturer of “to order” orthopedic and spineinstrumentation and implants of the highest caliber at one of the industry’sbest price points. Whether you are looking for a source to provide promptquoting and delivery, prototype or production capabilities, craftsmanshipfor difficult projects, or specific documentation, American Instrument &Implant can help. ISO 13485:2003.Page 16

Exhibitor Listing832. APS Materials4011 Riverside DriveDayton, OH 45405USA937-278-6547 (phone)937-278-4352 (fax)www.apsmaterials.comAPS is a leader in Plasma spray technology of both porous and bioactivecoatings for the orthopaedic marketplace. The coatings consist ofCommercially Pure (CP) Titanium and its alloys, specifically Ti 6Al 4V,as well as Hydroxyapatite, a calcium phosphate material that is used asa synthetic bone substitute. ISO13485:2003, ISO 9001:2000 and NADCAPcertified. FDA Master files for all our coatings.602. Arwood Machine Corp95 Parker StreetNewburyport, MA 01950USA978-463-3777 (phone)978-463-0666 (fax)www.arwoodmachine.comArwood Machine Corporation is a Veteran Owned, ISO 13485:2003 precisionmanufacturer of Medical Instruments. Since 1964 Arwood has invested in awide variety of machine tools to accommodate “one stop procurement” forthe medical industry. Our 81,000 square foot manufacturing facility includes4&5 axis machining, Screw Machining, Twin Spindle Machining, Wire EDM,Plunge EDM, Gun Drilling, Assembly, Welding, Passivation, Laser Markingand packaging complete.532. Arcam ABKroslatts Fabriker 30Molndal 431 37Sweden31-7103200 (phone)31-7103201 (fax)www.arcam.comAdditive Manufacturing of Orthopaedic Implants. Arcam’s Electron BeamMelting technology offers unique route to cost effective production ofstandard and custom implants designed with your trademark TrabecularStructure. Arcam offers a complete portfolio of equipment, software, metalpowder, service and training.520. ASTRO Medical Devices7124 Industrial Park BoulevardMentor, OH 44060USA440-269-6984 (phone)440-602-6091 (fax)www.astromedical.comThe Fine Art of Precision Machining. ASTRO Medical Devices specializesin implant production: spinal, orthopaedic, fixation and deformity, as wellas instrumentation. ASTRO Medical Devices offers tight tolerance Swissand 5 Axis CNC Machining capabilities, industry expertise and exceptionalcustomer service. From prototypes to production, we make your parts looklike “fine art” for the medical device industry. ISO 13485 certified.Page 17

Exhibitor ListingBronze Sponsor345. Autocam MedicalGlobal Headquarters4436 Broadmoor SEKentwood, MI 49512USA616-541-8080 (phone)616-698-6876 (fax)www.autocam-medical.comSingle-source contract manufacturer of precision-machined complex,highly engineered metal implants, instruments and components.Applications include orthopedic, spine, trauma, and reconstructivesurgery. A member of the Autocam group of companies, which includes 12facilities on four continents. Using lean manufacturing, value engineering,and continuous improvement principles, Autocam Medical leverages theentire production system to get a better product to market faster. ISO 9001and ISO 13485 Certified.201. Avalign Technologies272 East Deerpath Road, Suite 208Lake Forest, IL 60045USA800-996-2121 (toll free)260-480-5223 (fax)www.avaligntech.comPremier, full-service supplier of implants, instruments and delivery systems.Our expert engineering, diverse manufacturing capabilities and completededication to your project ensure success from start to finish. We comprisethree innovative companies: Nemcomed (Implants and Instruments);NGInstruments (Premium Cutting Instruments) and Advantis Medical(Cases and Trays). As a whole, Avalign Technologies brings the highestquality standard and custom products to our OEM customers acrossmultiple surgical specialties.624. Boedeker Plastics, Inc.904 West 6th StreetShiner, TX 77984USA361-594-2941 (phone)800-444-3485 (toll-free)361-594-2349 (fax)www.boedeker.comBoedeker is the country’s largest single-location stocking distributor ofhigh performance & industrial plastics in sheet, rod and tube. All ready forshipment at a moment’s notice. Our experience, personal attention to detailand passion for customer service will provide you with excellent results everytime you do business with us.Platinum Sponsor127. Bradshaw Medical, Inc.10325 58th PlaceKenosha, WI 53144USA262-925-1374 (phone)877-201-7661 (toll free)262-925-1380 (fax)www.bradshaw-medical.comQuality Surgical Instruments. Premier manufacturer of instruments forOEM companies within the orthopaedic, trauma and spinal markets.BMI’s goals are to provide innovative products to our customers withcareful consideration to price and delivery along with best-in-classcustomer service and technical support to aid both existing and developingprograms. ISO 13485:2003, ISO 9001:2000 certified. FDA Registered.626. Bob, Incorporated8740 49th Avenue NorthMinneapolis, MN 55428USA763-533-2261 (phone)763-533-1735 (fax)www.bobinc.comBob, Inc. specializes in close tolerance machining of implants for applicationssuch as, orthopedics, spinal, dental, ENT, neurology and urology. Prototypeto production assistance. Capacity to support large volume contracts utilizing60+ CNC machines that include 9-axis CNC swiss machines, robotic loadingCNC twin spindle lathes, high speed 5-axis CNC machining centers andCNC horizontal machining centers. Partnered with customers in ship-to-line,JIT, Kanban, supplier managed inventory and other programs as a resultof consistently shipping high quality products on-time. These programssupported by industry leading ERP solution that has integrated MRPcapabilities. ISO 9001:2008, ISO 13485:2003 and AS9100 Certified.500-501. Branch Medical Group200 Schell LanePhoenixville, PA 19460USA484-923-1073 (phone)877-992-7262 (toll free)www.branchmedicalgroup.comWe are contract manufacturers making world class spinal, orthopaedic,cardiovascular, dental and other implants. We design and manufacturethe graphic cases that house the implants and instruments. We do sterilepackaging, labeling and assembly. Our mission is to make “parts for life.”Our driving passion is to help customers LAUNCH products ON TIME.Why do we do it? We do it for life.712. Bodycote710 Burns StreetCincinnati OH 45204USA513-307-4727 (phone)513-921-2536 (fax)www.bodycote.comOperating an international network of facilities and serving a wide rangeof industries, including medical, aerospace, defense and power generation.Bodycote is the world’s largest and most respected provider of thermalprocessing services. Thermal processing is a vital part of any manufacturingprocess, and includes a variety of techniques and special engineeringprocesses which improve the properties of metals and alloys, extendingthe life of components. Surface Coating, HIP (Hot Isostatic Pressing), HeatTreatment and Metal Joining representatives will be present at OMTEC 2011to assist with any support Bodycote can provide.621. British Standards Institution (BSI)12110 Sunset Hills Road, Suite 200Reston, VA 20190USA703-437-9000 (phone)703-437-9001 (fax)www.bsiamerica.com/healthcareBSI Healthcare is a world class full-service Notified Body and Registrar,providing robust regulatory and quality management reviews andproduct certification for medical device manufacturers. We contribute toour clients’ success in the global medical device industry by acceleratingaccess to international markets. BSI services include CE Marking, IVD,ISO 13485, CMDCAS, Clinical Strategy Reviews, Japan PAL, FDA Third-Party Programs, Standards and Training. We are committed to providingprograms that combine speed with experience, integrity, independence andpredictability.Page 18

Contract manufacturing as sophisticated asyour implants.CAPABILITY, MEET CAPACITY.When it comes to spinal and extremityimplants, no one matches our technology,experience and reputation for quality. Withover ten 7-axis contour milling machines, noone takes you from prototype to full-scaleproduction faster. No one.✓ Orthopedic implants manufacturedand finished complete✓ Single operation milling and turningof complex geometries✓ Tolerances of +/-.0001"✓ Dedicated equipment formanufacturing PEEK implantsVertically Integrated Contract Manufacturing:• 7-Axis Contour Milling• Athermal Laser Machining• Laser Micromachining• Laser Welding & Marking• Electropolishing• CNC Turning• NiTinol Shape Setting• Prototype MachiningDepartments• Electrochemical Grinding• Swiss Micromachining• Wire & Conventional EDM• Cleanroom Assembly,Welding and PackagingISO 9001:2008 / ISO 13485:2003Corporate Headquarters5507 Avion Park DriveHighland Heights, OH 44143PHONE: 800-474-4322 / 216-761-5387 EMAIL: SALES@NORMANNOBLE.NET WWW.NNOBLE.COM

Exhibitor Listing515. Brown Precision, Inc.Chase Industrial Park90 Shields RoadHuntsville, AL 35811USA256-746-0533 (phone)256-746-0511 (fax)www.brownprecisioninc.comBrown Precision, Inc. (BPI) has gained 40 years experience in machining andmanufacturing in a diverse marketplace. AS9100 and ISO 13485 Certified,specializing in precision machining, we offer our customers multi-axis CNCmilling and turning, swiss turning, EDM machining, CNC gundrilling,abrasive waterjet machining and reverse engineering. Quality Engineers,Machine Operators, Project Engineers and Executive Management providededication to achieving excellence in the following areas: Engineering,Precision Machining, Custom Fabrication, Third-Party CMM Verification,Quality and Customer Satisfaction.414. CaP Biomaterials LLC2485 Corporate Circle, Unit 1East Troy WI 53120USA262-642-2760 (phone)262-642-2764 (fax)www.capbiomaterials.comCaP Biomaterials serves as a partner in bioceramics testing, speeding timeto market, improving existing products and assisting in the developmentof new applications. CaP manufactures consistent, high-quality, customcalcium phosphates including hydroxylapatite (HA), tricalcium phosphate(TCP) & biphasic (HA/TCP). Forms available: granulates, coatings, porousblocks, porous putty, press feed, spray feed & plasma spray. Applications:orthopedic, trauma, spine, dental & soft tissue implants. ISO 9001 Certified.245. C&A Tool Engineering, Inc.4100 North U.S. 33, PO Box 94Churubusco, IN 46723USA260-693-2167 (phone)260-693-3633 (fax)www.catool.comA world class full service medical device contract manufacturer ofhigh precision implants and instrumentation. With the individuals andequipment in place to hold 0.000040” (1-micron) tolerance and a state of theart metrology lab to provide qualification, C&A provides customer peaceof mind knowing that the tolerance requirements will be met. Allow ourtechnological expertise to be your solution for ultra high precision.227. Carpenter Technology Corporation101 W. Bern StreetReading, PA 19601USA610-208-2000 (phone)800-654-6543 (toll free)www.cartech.comLeading fully integrated developer, manufacturer and distributor of awide range of specialty alloys including biocompatible BioDur® alloys,stainless steels and titanium alloys. Alloys have been used in surgical,diagnostic, orthopedic, cardiovascular and dental applications. Formsinclude billet and long form bar, wire, precision strip, fine wire and ribbon,and custom shaped bar and wire. Service centers on four continents. Free,comprehensive technical information database at www.cartech.com. ISO9001:2008.142. Cam BioceramicsLeiden Bio Science ParkZernikedreef 6Leiden 2333 CLThe Netherlands31-71-5240600 (phone)31-71-5240650 (fax)www.cambioceramics.comWe Help Bone Grow. We were the first company to apply a bioceramiccalcium phosphate (hydroxyapatite) coating to medical prostheses like hipsand knees as well as spinal implants, both metals and polymers. We havequick turnaround times and an excellent quality system. Cam Bioceramicsis a renowned producer, key supplier and partner (B-to-B) of syntheticbioactive and osteoconductive biomaterials, such as coating powders andgranulates, to the orthopaedic and spinal industries worldwide.126. Centex Machining, Inc.PO Box 1479Round Rock, TX 78680USA512-255-1477 (phone)512-388-3606 (fax)www.centexmachining.comManufacturing Support for the Orthopaedic Industry. Exclusivemanufacturing support for U.S. orthopaedic companies. Customer designcollaboration and new product launches are our specialty. We realize theimportance of being a market leader, and we’ll dedicate whatever resourcesare required to ensure that your new product launch comes off withouta hitch. Hips, knees, shoulders, spinal devices. Implants, provisionals &instruments. FDA-registered.731. Canwell Medical Ltd.No. 466 South Xianhua Str.High-tech Industrial ZoneJinhua, Zhejiang, 321016P. R. of China86-579-8223-9098 (phone)86-579-8223-9558 (fax)www.canwell.com.cnCanwell Medical Ltd., an Orthopaedic Products & Instruments OEMSolution Provider in China mainland, was founded in May 1994. We startedby manufacturing CPM and then successfully stepped into the orthopaedicindustry led by some world-famous orthopaedic giants in 2003. Today, weare one of the largest suppliers of trauma, spine and joint instruments &implants to many of the world’s top 10 orthopaedic companies.215. Curbell Plastics, Inc.7 Cobham DriveOrchard Park, NY 14127USA716-667-3377 (phone)888-287-2355 (toll free)716-667-3432 (fax)www.curbellplastics.comMedical-grade polymers including Radel® R, Celcon® M25 Acetal, PEEK,Ultem®, Polyproylene and Polysulfone. Curbell’s ISO 9001:2008 qualitysystem ensures lot and batch traceability, appropriate paperwork andcertifications with every order. Our medical-grade materials comply withagency standards including USP Class VI, ISO 10993-5 and FDA. We alsooffer material selection and technical assistance.Page 20

A▲Fold on dashed lines. Align A to B.▲BStartFinishConceptDevelopmentPassivateShipDesignEngineerSchedulePackageMillTestCleanProcessCleanShipPackCodingShrink-WrapStorageUnpackInspectionBoxInventoryTurnLaser EtchPolishPrototypePorous CoatDiamond CoatPassivation Test Fabrication IntegrateRaw MaterialMicro DeburQualificationLabelMachineMachinePilot ProgramPilot ProgramLabelForgeTroubleshootTPS CoatCodeCoatDeliveryMicro DeburDrillShipInspectionGage DesignShrink-WrapStorageUnpackProcessBoxInventoryDesignLaser EtchMill Process HA Coat EngineerElectro Polish Ship Pack CodingA▲▲BThink of everything you’ll simplify if you go lean.Like operations, processes and workload, for starters. We’ve found thatlean manufacturing is the best way for our customers to lose the wait.By tying our value stream to theirs, we’re able to implement principlesthat remove waste, decrease cost and shorten lead times. The end result?Less effort, investment, inventory and logistics for you. And more overallcustomer value for us. Find out how lean manufacturing with Orchid cansimplify your life. Contact: thinklean@orchid-orthopedics.comVisit us at OMTEC, Booth 331-333ORCHID ORTHOPEDIC SOLUTIONS(517) 694-2300 www.orchid-orthopedics.com©2008 Orchid Orthopedic Solutions LEA-1-3

Exhibitor Listing608. Deloro Stellite Group (c/o ATS Stellite)ZI De Brueges - BP 8028630106 Ales CedexFrance33-4-66-30-47-03 (phone)33-4-66-78-75-64 (fax)www.stellite.comDeloro Stellite serves the orthopedic and medical industries with state-ofthe-artmanufacturing services, to help them produce advanced implantsand instruments with the highest quality. Partner of our customersproduct developments, we propose appropriate solutions. We offercomplete supply-chain management tools, to help our customers toimplement just-in-time programs, with single source accountability. With13 sites worldwide, Deloro Stellite is in a position to support local loop anddeploy expertise.713. Electrolizing Corp. of Ohio, The1325 East 152nd StreetCleveland, OH 44112USA216-451-8655 (phone)800-451-8655 (toll free)216-451-4729 (fax)www.electrohio.comThe Electrolizing Corp. of OHIO is a proven leader in specialty coatingsfor the medical device and implant industry. All processes are validatedto Global Harmonization Task Force guidelines, including our proprietaryMedcoat 2000 and Ti-Med processes. Visit www.medcoat2000.com for moreinformation on all of our completely validated processes. ISO 9001:2008.601. Dexcowin Co., Ltd#606 Woolim Lions Vally II Gasan Dong153-803 GeumCheon Gu, SeoulKorea82-2-2027-2880 (phone)82-2-2027-2884 (fax)www.dexcowin.comDexcowin Co., Ltd was established in 2004 in South Korea. We are amanufacturer of a portable, battery-powered X-ray machine. Our goalis to contribute to healthier and better humans. Our advanced andcreative technology focuses on easy carry and fast diagnosis in a mobileenvironment. Dexcowin’s products have been sold for five years in over 40countries. We have all kinds of product registrations and local country levelcertificates including CE and FDA.102. Electropolishing Systems, Inc.24 Aldrin RoadPlymouth, MA 02360USA508-830-1717 (phone)508-830-1789 (fax)www.electropolishingsystems.comElectropolishing Systems provides high-quality, close tolerance metalfinishing services to the medical device industry. ESI uses variousstatistical tools including FMEA and DOE to meet specific validationrequirements, including Biocompatibility. Our formal control plans andQuality Systems yield highly reliable and repeatable results. Servicesinclude ultrapure electropolish, multialloy passivation, titanium andaluminum anodizing, chemical polishing of nitinol, laser marking andcleanroom packaging. ISO 9001 & ISO 13485 certified.421. Donson Machine Co.12416 South Kedvale AvenueAlsip, IL 60803USA708-388-0880 (phone)708-388-4308 (fax)www.donsonmachine.comDonson is a specialized contract manufacturer of precision machinedcomponents for orthopaedics and medical equipment. We focus on complexdesigns and demanding applications requiring state of the art equipmentand engineering. Donson supplies implants and instruments to industryleadingmanufacturers and is geared for quick-turn prototyping, short-runcustoms/specials and production.218. Emerson Consultants, Inc.12701 Whitewater Drive, Suite 120Minnetonka, MN 55343USA952-374-6000 (phone)www.emersonconsultants.comEmerson Consultants, Inc. is a Consulting Firm and Contract ResearchOrganization (CRO) for the medical technology and biologic sectors.Emerson provides strategic consulting in the areas of Reimbursement,Regulatory Affairs, Clinical Research, and Sales and Market Development.Emerson’s experienced team of consultants collaborates with clients,comprising both emerging and established market leaders, to design andimplement strategies that generate revenue and clearly differentiate theirproducts and services in the marketplace.830. Durr Ecoclean Inc.Cleaning and Filtration Group31077 Durr DriveWixom, MI 48393-2435USA248-560-2100 (phone)248-560-2080 (fax)www.durr-ecoclean.comWith innovative standard solutions and individually customized cleaningsystems, Dürr Ecoclean meets international requirements on cleannessin diverse industries such as the production of mechanical components,aviation and space flight, medical technology, the food industry, electronicsand laboratory equipment.531. ENDO Manufacturing Co., Ltd5-3 Chuo DoriTsubame-shi, Niigata-ken 959-1244Japan81-256-63-6610 (phone)81-256-64-2466 (fax)www.endo-mfg.co.jpEstablished in 1950. 215 employees. Supported by the techniques inprecision forging, machining and polishing, we supply high-performanceforged joint implants fast. We apply an “Integrated manufacturing system”allowing us to achieve outstanding lead-time and competitive costperformance. Recently, we have been offering “Custom-made” forgingto supply higher value-added products. We are capable of delivering topquality products which satisfy your requirements with competitively shortlead-time.Page 22

Exhibitor Listing125. ENSINGER INC.365 Meadowlands BoulevardWashington, PA 15301USA724-746-6050 (phone)724-746-9209 (fax)www.shopforplastics.comAutoclavable plastic shapes in a variety of colors supported with ISO 10993testing for the intended use of surgical instruments in contact with bloodand tissue. Radiolucent carbon composites with high stiffness and radioopaque grades for safety and to accommodate MIS procedures.733. Finishing Innovations, LLC578 Highway 70Mason, TN 38049USA901-294-2848 (phone)901-294-3070 (fax)www.finishinginnovations.comBeginning with H900 heat treat thru polishing, hard chrome electroplating,electro polish and laser etch, Finishing Innovations sets the standard fordelivering validated orthopedic metal finishing services in today’s rapidturnaround environment. Simply put, Finishing Innovations deliversunmatched quality, delivery and service in the orthopedic surface finishingindustry. ISO 13485 Registered. For more information, visit www.finishinginnovations.com402. EPTAM Plastics2 Riverside RoadNorthfield, NH 03276USA866-443-7826 (toll free)603-286-3977 (fax)www.eptam.comISO 13485:2003 & ISO 9001:2008 Registered; specializing in machiningprecision polymer components. Offering 7, 5 and 3 Axis machining, withdry machining technology. Our skilled machinists fabricate complexcomponents and instruments from Acetals, Ultem, Radel, PEEK and carbonfiber, as well as implants from UHMW-PE and PEEK. Our experience andstrong systems support ensure that the quality of your components meetsyour specifications and exceeds your expectations.415. FMI Medical Instruments505 Production AvenueMadison, AL 35758USA256-461-0900 (phone)256-461-0929 (fax)www.fmi-medical.comContract manufacturer of precision machined implants and instruments.FMI utilizes the latest technology in 3D solid modeling and multi-axisCNC programming software, as well as the latest advancements in multitaskingCNC machines. We have extensive experience manufacturingspine and small bone devices. We can manufacture your most demandingapplications.315. Esprit/DP Technology1150 Avenida AcasoCamarillo, CA 93012USA805-388-6000 (phone)800-627-8479 (toll free)805-388-3085 (fax)www.dptechnology.comDP Technology is a computer-aided manufacturing (CAM) software marketleader with a mission to provide CNC programmers with the most powerfulCAM software ever. DP Technology’s flagship product, ESPRIT, captures thecompany’s vision of technology’s potential and its passion for excellence.120. Forecreu America Inc.4118 North Nashville AvenueChicago, IL 60634USA773-539-8501 (phone)773-539-8627 (fax)www.forecreu.comForecreu America Inc. offers heavy wall tubing (cannulated bars) intitanium and stainless steel for medical instruments/implants. Sizes rangefrom 0.156 in. to 0.625 in OD and 0.031 in. to 0.169 in. ID. Some larger IDsare available for IM nails or specific applications. The company also offerssolid 455C and 465C.619. Fairview Machine Company, Inc.427 Boston StreetTopsfield, MA 01983USA978-887-2141 (phone)978-887-3689 (fax)www.fairviewmachine.usFairview Machine is an ISO 13485 & ISO 9001 registered precisionmanufacturer of orthopaedic implants, spinal products and medical devices.Within a lean manufacturing environment with an extensive range of CNCcapabilities, such as 5-axis high speed machining, 8-axis combination turningand milling in one operation and 5-axis Wire EDM, Fairview is able to achievesuperior surface finishes and hold the tightest of tolerances on metal andplastic devices with the most challenging part geometries. Services includerapid prototyping, product launch, high production and vendor managementinventory. We provide the best overall value for our customers.514. Fort Wayne Metals9609 Ardmore AvenueFort Wayne, IN 46809USA260-747-4154 (phone)260-747-0398 (fax)www.fortwaynemetals.comPrecision Wire and Cable for Medical Products. Round wire, centerless andprecision ground rod, strands, cables, flat wire and DFT wire. Startingstock for the most popular orthopaedic alloys including: 316LVM, titanium/titanium alloys, L605, CCM®, Custom® 455, 17-7PH®, 17-4PH®, MP35N®,Nitinol, 304V and others. All of our production facilities and quality systemsare geared specifically for producing medical grade products.Page 24

Exhibitor ListingPremier Sponsor609. GEHRING CUT AGAlte Poststrasse 59548 MatzingenSwitzerland011-41-52-369-6969 (phone)011-41-52-369-6978 (fax)www.gehringcut.comGEHRING CUT AG from Switzerland is a very reliable contractmanufacturer for challenging applications. Complete production ofinstruments and implants for orthopaedic surgery. For more than twodecades, we’ve learned an extensive experience manufacturing hip, spineand knee instruments. With a state of the art machine shop, we guaranteequality you demand, from prototypes to long runs to the final inspection ofassemblies. ISO 9001:2000 and ISO 13485:2003 certified.246-247. Greatbatch Medical10000 Wehrle DriveClarence, NY 14031USA716-759-5540 (phone)716-759-2562 (fax)www.greatbatch.comGreatbatch Medical is committed to the design and manufacture of criticaltechnologies that enhance the reliability and performance of medicaldevices and procedures. We do this to ensure that our customers cancontinuously provide clinicians with better treatment options to improvepatient outcomes.319. Gibraltar Laboratories122 Fairfield Road16 Montesano RoadFairfield, NJ 07004-2405USA973-227-6882 (phone)973-227-0812 (fax)www.gibraltarlabsinc.comISO 17025 certified, A2LA accredited, FDA registered laboratory. Anoutstanding record with FDA and the broad outsourcing industry. Ouradvantages include a validated electronic reporting system and BSL-3laboratory to provide consistent, rapid, and reliable results. Offeringfriendly, dependable and excellent customer service, customer loyalty hasbeen an established result. We are always focused on quality, turnaroundtime and lasting strong relationships.618. gSource, LLC19 Bland StreetEmerson, NJ 07630USA800-978-1119 (toll free)201-599-2277 (phone)201-599-3306 (fax)www.gSource.usThe Orthopaedic reSource for Surgical Instruments. gSource is a trustedand reliable partner to many world leaders in orthopedics and spine. Weprovide superior instrumentation in a time-critical fashion and at realisticprices. From prototypes to full-run production, we are committed to being avaluable business partner, always providing a real return on investment.Page 25

Exhibitor Listing320. Hangsterfer’s Labs175 Ogden RoadMantua, NJ 08051USA856-468-0216 (phone)856-468-0200 (fax)www.hangsterfers.comCoolants and lubricants used in all sectors of the metalworking industry. Weare a family owned and operated company born in 1937. Together we willovercome costly machining problems, reduce down-time and maintenancecosts and dramatically improve your company’s bottom line. Hangsterfer’sengineering staff and knowledgeable representatives are ready to answeryour questions and solve your problems!530. In’tech Medical Inc.2851 Lamb Place #15Memphis, TN 38118USA901-375-1109 (phone)901-367-2977 (fax)www.intech-medical.comManufacturing Solutions for the Orthopaedic Industry. Contractmanufacturer of orthopaedic and spinal instruments and implants.Management team with over 20 years of experience making products forthe world’s leading orthopaedic companies. State of the art machineryand innovative processing techniques combine to provide comprehensiveturnkey manufacturing solutions to your outsourcing projects. Let us beyour manufacturing partner. ISO 13485:2003 certified.408. Hansa Medical11430 Tamiami Trail EastNaples, FL 34113USA239-775-9090 (phone)239-793-2940 (fax)www.hansa-medical.comOur main focus is the medical industry, creating precision devices foruses from vascular to orthopedics. Not only do we specialize in devices,but we fabricate high precision molds along with the core pin, core pinhandles, holders and cavities. In order to provide extraordinary parts forour customers, we have a full range of machines and software to meet thestringent demands and tight tolerances that engineers demand. The qualityscope of Hansa is ISO 13485 & 9001:2008 Certifications detailing the abilityof our company to produce orthopedic implants and instruments, alongwith passivation & Class 10,000 clean room services.625. International Titanium Association2655 West Midway Blvd, Suite 300Broomfield, CO 80020USA303-404-2221 (phone)303-404-9111 (fax)www.titanium.orgThe International Titanium Association (ITA) is a membership based,international trade association dedicated to the titanium metal industry.ITA’s mission is connecting the public interested in using titanium withspecialists from across the globe who may offer sales and technicalassistance. ITA also sponsors workshops, committees and hosts the onlyannual TITANIUM conference. www.titanium.org.308. Hoosier, Inc.1152 California AvenueCorona, CA 92881USA951-272-3070 (phone)951-272-8090 (fax)www.hoosierinc.comWith 3, 4, 5 and 7 axis machining, we offer the widest range of machiningapplications and complexity. We’ve done it all: implants, surgicalinstruments, inserters, plates, sizers, screws, fixation systems, caddies, trays,trials. We machine wet and dry, with dedicated cells for strictly dry implantmachining. Plastic, SS, titanium, you pick the material, “We Will” deliver.Our Swiss turn capabilities utilize the latest in new technology to make yourparts fast and to print.518. Ionbond, Inc.200 Roundhill DriveRockaway, NJ 07866USA973-586-4700 (phone)973-586-4729 (fax)www.ionbond.comIonbond is the leading international provider of BioCeramic coatingproducts and services for the medical device industry. We offer state of-theartbiocompatible coatings with technical consultation for instrument andimplant applications. Our products have been tested for biocompatibilityaccording to the complete ISO10993-1 protocol and are FDA Master Filed.Ionbond processes are well documented and are in conformance withISO 9001:2008 and ISO13485:2003 Quality Management Systems. Theprocesses are validated and meet the requirements of the Medical Deviceindustry.615. Infinity Plastics Group5520 Industrial RoadMt. Vernon, IN 47620USA812-831-5106 (phone)812-838-9301 (fax)www.infinity-mai.comI N F I N I T YI N F I N I T Y P L A S T I C S G R O U PDiscover an easier way to develop new plastics products with amanufacturing partner who understands. Infinity Plastics Groupunderstands what “speed to market” means to new programs. Weunderstand what “well designed parts” means to new programs. Infinityunderstands what “total support” means to new programs. Why do weunderstand? Our engineers are experienced design experts who havelaunched thousands of successful injection molded plastics programsduring our 29-year history. We can help you succeed.326. Jarvis Surgical, Inc.53 Airport RoadWestfield, MA 01085USA413-562-6659 (phone)413-562-1988 (fax)www.jarvissurgical.comManufacture and Polishing of Orthopaedic Implants and Instruments.Contract manufacturer of hip femoral/acetabular and knee femoral/tibial components, knee augmentation blocks, specialty screws, bipolarshells, standard and modular humeral components, including heads, trialcomponents, instruments, spinal and trauma products. Our integratedhand and robotic polishing services are utilized by top orthopaedic OEMs.Page 26

Risks are hiding everywhere in the orthopedicindustry. This even includes the document thatis meant to protect you from risks - yourinsurance policy. Our NewScience Insuranceadvisors will conduct a no-risk review of yourcurrent policy and let you know where yourexposures lie. Call us at 440-248-4711 and letus shine a light on the risks in your policy.Visit NewScience Insuranceat Booth 426 at OMTECJuly 15-16, 2011800-607-4711 | www.newscienceinsurance.com

Exhibitor Listing109-208. Juno Inc.1040 Lund Boulevard NWAnoka, MN 55303USA763-427-6141 (phone)763-427-7252 (fax)www.junoinc.comJuno Inc. is an ISO 13485 registered full-service contract manufacturerspecializing in micromolding, single and multishot injection and insertmolding of engineering resins in various levels of clean environments fromISO Class 7 to Class 9. The company also manufactures custom sterilizationcases and trays in anodized aluminum and stainless steel.101. Level 3 Inspection/Smart Inspection Systems3123 East Center StreetWarsaw, IN 46582USA888-4AS-9102 (888-427-9102) (phone)561-775-7911 (sales)www.level3inspection.comwww.smartinspectionsystems.comLevel 3 Inspection, a full-service ISO 9001 registered inspection &engineering firm, proudly introduces its Smart Inspection Station, asupercomputer-equipped turnkey White Light Scanning solution readyfor the orthopedic manufacturing floor. The SiS provides completesurface digitization to accuracies of 0.000040”, complete Computer AidedInspection reports in minutes and traceable/trendable/trackable data withminimal operator training.725. Kens FineMedtech Sdn. Bhd.Plot 19, Hilir Sungai Keluang 2,Phase 4, Free Industrial Zone,Bayan Lepas, Penang 11900Malaysia60-4-616-1356 (phone)60-4-616-1353 (fax)www.kensfinemedtech.comKens FineMedTech was incorporated in Malaysia in 2007. The companywas formed to undertake the contract manufacturing of orthopaedicdevices, dental devices, cases, trays and instruments. Our engineering teamis enriched with the state-of-the-art technology to ensure superior qualityproducts at all times to meet customers’ requirements and expectations.We offer design & development of orthopaedic & dental devices andinstruments, prototyping and process development. ISO 13485: 2003 andFDA-510(k) Approval.502. Maetta75, De Mortagne Boulevard, Suite 109Boucherville, Quebec J4B 6Y4Canada450-641-07534 (phone)450-641-5468 (fax)www.maetta.caMaetta specializes in net-shape manufacturing of metallic and ceramic partsusing the powder injection molding (PIM) manufacturing process. Clientservice is enhanced by working at all stages of the PIM process, “frompowder to product,” to reduce costs and meet specific mechanical, chemicaland dimensional requirements. Maetta works closely with its clients toreduce development and manufacturing costs of parts, improve design andcreate new materials with unique properties. Maetta also develops PIMbasedprototyping tools, manufacturing equipment and engineering tools(the Maetta System) aimed at increasing its clients’ product developmentcapacity and prototyping flexibility as well as reducing time-to-market ofproducts by accelerating transferability to high volume production.200. Knight Mechanical Testing6016 B Highview DriveFort Wayne, IN 46804USA260-489-1444 (phone)260-818-2036 (fax)www.knighttesting.comISO/IEC 17025:2005 Accredited - Independent Mechanical Test LaboratoryKMT offers independent ISO/IEC 17025:2005 accredited mechanical testingservices focused on ASTM, ISO and customer specified test methods fororthopaedic devices. Orthopaedic OEM laboratory experience - all MTSlaboratory equipment. Can pot hips, knees and extremities and can designand fabricate specialty fixturing for trauma and spine products.413. Mahar Tool Supply Company, Inc.3568 U.S. 30 EastWarsaw, IN 46580USA574-267-0032 (phone)800-456-2427 (toll free)574-267-0076 (fax)www.maharmedical.comDistribution & Commodity Management in Cutting Tools & More!Specializing in metal-removal and distribution since 1947. Offeringproducts, services and consultation to meet your tooling & inventorymanagement needs. We take pride in offering custom solutions thatgenerate bottom-line savings. ISO 9001:2000 and WBENC certified.114. LAB Medical Manufacturing Inc.28 Cook StreetBillerica, MA 01821USA978-663-2475 (phone)978-663-4364 (fax)www.labmedical.comMedicalLAB Manufacturing, Inc.512. Makino7680 Innovation WayMason, OH 45040USA513-573-4584 (phone)513-573-7360 (fax)www.makino.comISO 13485 certified and FDA approved manufacturer that has manufacturedand supplied the highest quality instrumentation and implants toleading OEMs for over 25 years. Design assistance, precise dimensioning,process validating and fatigue-stress testing of implant components. Wevalue and work hard to develop long-term relationships. Some of ourcustomers have been with us since our inception. We partner with themon technical issues and understand their unique needs, the intangibles thatmake the difference in project success. Ready, we stand, to provide yourcompany with prototyping and economical solutions.A world leader in advanced CNC machining centers, Makino provides awide range of high-precision metal-cutting and EDM machinery, includinghorizontal, vertical, 5-axis and graphite machining centers and wire andRam EDMs. Our flexible automation solutions provide reduced labor costsand increased throughput in a variety of production volumes and designs.With Makino engineering services, we offer industry leading expertise foreven the most challenging applications across all industries.Page 28

Exhibitor ListingEvent Co-Sponsor214. Marketwire200 West AdamsChicago, IL 60606USA312-261-4218 (phone)312-261-4220 (fax)www.marketwire.comMarketwire advances the way the world communicates. We deliver newsto traditional and social media audiences and leverage the latest in searchengine optimization, multimedia, content management and social mediaanalytics to maximize the power of our clients’ communications. For moreinformation, visit us online at www.marketwire.com, www.marketwireblog.com, or on Twitter @marketwire.312. Medin Corporation90 Dayton Avenue, Building 16CPassaic, NJ 07055USA973-779-2400 (phone)800-922-0476 (toll free)973-779-2463 (fax)www.medin.comManufacturer of Standard and Custom Sterilization Containers, Cases,Trays & Devices. Experience with aluminum, SS, thermoformed plasticsand hybrids. Computer-driven Total Process Control enables us to meetcritical launch deadlines because we don’t outsource. Punching, bending,machining, milling, riveting, welding, clear or color anodizing and hardcoating, nylon coating, surface or deep cavity silkscreening and laseretching. ISO 13485:2003 Certified.425-427. Marox Corporation373 Whitney AvenueHolyoke, MA 01040USA413-536-1300 (phone)413-534-1829 (fax)www.marox.comManufacturer of Implants, Instruments, Devices. Precision machining andassembly of orthopaedic, spinal and trauma implants and instruments.Specialties include CNC milling (up to 5-axis), CNC 7-axis mill/turn, CNCSwiss screw machining (up to 12-axis), CNC thread whirling, CNC wire/ram EDM and assemblies. Services include prototypes, product launching,production, project management and vendor managed inventory. ISO 13485registered.513. Medivative Technologies2950 North Caterwood AvenueIndianapolis, IN 46219USA317-547-3640 (phone)www.medivative.comDesign and development, prototyping, engineering, high and low volumemanufacturing, Uniquely positioned to provide contract development andmanufacturing services to orthopaedic companies. Whether your productis a powered surgical instrument, complex diagnostic instrument, highvolume disposable or instrument case, our quality systems ensure theconsistent quality and traceability that your products require.www.cambioceramics.com booth 142 OMTEC 2011Page 29

Exhibitor ListingGold Sponsor509. Metal Craft Machine & Engineering13760 Business Center DriveElk River, MN 55330USA763-441-1855 (phone)763-441-0798 (fax)www.metal-craft.comMetal Craft and Riverside are proud to be Woman Owned, World Classsuppliers to the top OEM’s for over 30 yrs. With two state of the art fullyvalidated facilities and dedicated staff of 190+, we provide superior qualityin complex assemblies, surgical instruments & implants. We maintain acollaborative partnership with our customers in dFMEA and pFMEA toensure quality in and cost out. We bring the Quality, Service and Innovationto you. Certifications: ISO 9001 & 13485, AS9100.631. Minnesota Rubber & Plastics1100 Xenium Lane NorthMinneapolis, MN 55441USA952-927-1400 (phone)952-927-1470 (fax)www.mnrubber.comMinnesota Rubber and Plastics: custom molder of components andassemblies. Specializing in silicone over-molding of surgical instrumentsand medical grade high-performance materials for implants. Servicesinclude product development, prototyping, manufacture and packaging.Class 10,000 & 100,000 clean rooms. Global manufacturing, ISO 13485certified, FDA registered, FDA Class 1, 2 and 3 products including CEproducts.826. Micro Machine Company2429 North Burdick StreetKalamazoo, MI 49007USA269-388-2440 (phone)269-388-5466 (fax)www.micromachineco.comMicro Machine Company is a privately owned medical device contractmanufacturer, offering full product support for concept, design formanufacturability, product launch and sustained manufacturing. Ourcore competencies include, complex surgical instrumentation, implants(including PEEK), packaging, labeling, VMI and a custom “cost-plus” fastTime to Market prototype program.627. NeedleTech Products, Inc.81 West StreetAttleboro, MA 02703USA508-431-4000 (phone)508-431-2156 (fax)www.needletech.comExcellence in Everything We Do. Full service, ISO 13485:2003 certifiedmanufacturer of specialty needles and related medical devices. Supplyingthe orthopaedic market with K-Wire, Steinmann Pins, Trocars and GuideWires. Servicing the Vertebroplasty markets with Access Needles, Reamers,Biopsy Devices, Cement Delivery and Aspiration Needles. We satisfy ourcustomers every day. Plastic components up to 14 ounces. Complete design,prototyping, tool making, R&D, compounding, clean room and testingservices.524. Microware Precision Co., Ltd.No.12, Keyuan 2nd Rd., Situn DistrictTaichung City 40763Taiwan886-4-2463-6275 (phone)886-4-2463-6276 (fax)www.microware.com.twWorld leading manufacturer in metal machining for complicated geometricparts with high precision. We provide a total solution for any kind ofmetal cutting, especially for medical use stainless steel and titanium.In addition to providing top manufacturing service, we also offerdesign recommendations to help customers obtain better efficiency inmanufacturing and cut the manufacturing cost.Platinum Sponsor113. Millstone Medical Outsourcing, LLC580 Commerce DriveFall River, MA 02720USA508-679-8384 (phone)508-679-8414 (fax)www.millstonemedical.comMillstone Medical Outsourcing is a leading and innovative provider ofcustomized outsourcing solutions to the medical device industry. Thecompany offers advanced inspection, sterile and non-sterile packaging,loaner kit processing and distribution to medical device and productmanufacturers worldwide. Millstone operates three state-of-the-artfacilities, the company’s two facilities in Fall River, Massachusetts and thestrategically-located loaner processing and distribution center in Memphis,Tennessee. Superior quality service and improved ROI are advantagesclients expect from Millstone Medical Outsourcing.426. NewScience Insurance,A Division of Britton-Gallagher &Associates Inc.6240 SOM Center RoadCleveland, OH 44139USA440-264-1326 (phone)800-607-4711 (toll free)440-248-5406 (fax)www.newscienceinsurance.comwww.Britton-Gallagher.comWe design a total insurance solution for the risks faced by orthopaedicdevice manufacturers and distributors, with a tailored portfolio of propertyand liability products to help protect your company’s balance sheet fromthe financial devastation of a loss or lawsuit. Orthopaedic companies arein a highly regulated environment and have very little time to sort outcomplicated insurance and risk management issues. We can help.632. Norman Noble, Inc.5507 Avion Park DriveHighland Heights, OH 44143USA216-761-5387 (phone)216-761-0455 (fax)www.nnoble.comNorman Noble manufactures medical devices and implants to customerspecifications in compliance with FDA regulations and ISO 13485:2003. Fullcapabilities include orthopaedic implant manufacturing, 7-axis contourmilling, Swiss machining, laser machining & welding, EDM services andnitinol shape setting. Prototype services are also available.Page 30

ResponsiveInstrumentSolutionsfor SpinalApplications90,000Forgings In StockPAK MANUFACTURING has beenserving satisfied customers in theSPINAL market for more than tenyears.Our style of superior service andresponsiveness has made us aleader in the production of customand specialty spinal instruments,with well over 45 active customers.Having our own facilities andequipment here in the USA hasallowed us to distinguish ourselvesby offering and performing to highlyaggressive lead-time commitmentswhile maintaining superior qualityand competitive pricing.We understand your needs,let us be your instrument partner!• Experienced manufacturer of allcustom spinal instrumentsincluding cervical, thoraco-lumbarand disc replacement• Multi-axis CNC equipment andonly certified materials providesoptimal assurance of instrumentintegrity• Forging-based production insureshighest value and aggressive leadtimes• US manufactured in our own30,000 square foot facility• State of the art inspectionequipment and facilities assuresstrict conformance to customerrequirements• Unmatched responsiveness!"Manufacturers of custom and specialtyhand held orthopaedic instruments from forgings"704 South 21st Street, Irvington, NJ 07111Tel (973) 372-1090 • Fax (973) 372-1091Email info@pakmanufacturing.comWebsite www.pakmanufacturing.com© 2006 PAK Manufacturing, Inc. All rights reserved.

Exhibitor ListingPlatinum Sponsor721. NSE-Automatech790 boul. IndustrielGranby, Québec J2G 9J5Canada450-378-7207 (phone)450-378-9651 (fax)www.nse-automatech.comNSE-Automatech is specialized in the manufacturing of complexmechanical assembly for various industries: Aviation (Aircraft parts);Medical (complex surgical tools); Electronic; Automotive and AerospaceAvailable Processes include: High precision CNC 3, 4 and 5 axesmachining of typical and exotic materials; Unigraphics and Catia softwareprogramming; Wire and electrode EDM; TIG and MIG welding; Assemblyroom; Passivation room; Laser and dot peen marking and CMM inspection.331-333. Orchid Orthopedic Solutions1489 Cedar StreetHolt, MI 48842USA517-694-2300 (phone)517-694-2340 (fax)www.orchid-orthopedics.comWorldwide leader in contract design and manufacturing for theorthopaedic, dental and cardiovascular markets. Our mission is to be theleader in contract medical design and manufacturing by compressing timeto market, providing new technology and being the best total supplychainvalue. Comprising five divisions that offer an array of implants andinstruments within the five core capabilities: design, forging, machining,plastics and coatings.325. Oak View Tool Company724 East Swihart StreetColumbia City, IN 46725USA260-244-7677 (phone)260-244-7466 (fax)www.oakviewtooling.comOak View Tool, sister company to SGS Tool, is a global leader in productionof rotary carbide cutting tools. This relationship provides Oak View Toolwith a global reach and SGS Tool with local access to the orthopaedicindustry. OVT specializes in state of the art quality cutting tools forthe medical & industrial marketplace (certified to ISO 9001:2008 & ISO13485:2003). Special carbide end mills & unique, custom designed stainlesssteel instruments are our competence. Located near Warsaw, Indiana (theorthopaedic capital). Let our experienced personnel provide you withquality, from design to delivery…fast.313. Orthoplastics, Ltd.Grove Mill, Todmorden Road, BacupLancashire OL13 9EFUnited Kingdom44-1706-871-200 (phone)44-1706-875-726 (fax)www.orthoplastics.comUniquely focused on Orthopaedic Plastics. Orthoplastics is the genuineone-stop-shop for both implantable and instrument grade materials.Quality and Process Controls are unsurpassed anywhere in the world. Ourproducts include UHMWPE, PEEK, PMMA, POM (Acetal), PEI (Ultem),PPsu (Radel) plus a range of specialist materials. All certified using our inhouselaboratory that is also available for bespoke research.825-827. Okuma America Corporation11900 Westhall DriveCharlotte, NC 28278USA704-588-7000 (phone)704-588-6503 (fax)www.okuma.comOkuma America Corporation is a leading provider of CNC machine tools -horizontal and vertical lathes, machining centers and grinders. Developerof the world’s first open-architecture machine tool control, THe IntelligentNumerical Control (THINC®), Okuma strives to provide metal-cuttingoperations with manufacturing solutions to increase productivity, improvequality, reduce costs and help them meet the exacting demands and qualityrequired of the high precision medical device industry.Silver Sponsor433. Onyx Medical Corporation1800 North Shelby Oaks DriveMemphis, TN 38134USA901-323-6699 (phone)901-454-0295 (fax)www.onyxmedical.netOnyx is your world-class manufacturing partner, offering verticallyintegrated solutions from concept design through dock-to-stock inventoryfor orthopedic cutting, nailing, fixation and navigation devices. Onyxis FDA registered, ISO certified and committed to delivering on yourspecifications and exceeding expectations – always.730. OTEC Precision Finish Inc44 Cross Park AvenueNorth Kingstown, RI 02852USA401-398-0045 (phone)401-398-0056 (fax)www.otec.deFounded in 1996, OTEC has established itself as one of the most innovativeand technologically advanced mass finishing equipment suppliers in theworld. With offices and sales partners worldwide, OTEC can provide stateof the art, high energy polishing and deburring systems for all orthopaedicimplants and tools, bone plates and screws, spinal products, orthodonticdevices and dental implants and tools. OTEC offers a wide range ofcentrifugal disc and drag finishing machines, from simple bench top units tofully automated systems. Put us to the test by sending us your samples. ISO9001:2000 certified.718. Pacific American Life Science Learning Center5288 Eastgate MallSan Diego, CA 92121USA866-943-4589 (phone)858-866-0760 (fax)www.LifeScienceLearningCenter.comLife ScienceLearning CenterThe Life Science Learning Center is San Diego’s only private bio-skillsfacility designed for hands on training and education for medicalprofessionals. Now offering a 10 station lab, complete with full lockerrooms and a state-of-the-art auditorium with seating for up to 50 attendees.Check out a photo tour of our lab on YouTube: www.youtube.com/user/pamsLSLC.Page 32

PowerfulSolutionsFrom Concept Through Production& Every StepIn BetweenWhether you’re starting with a napkinconcept or a fully-designed product that you’dlike to outsource, Pro-Dex delivers reliableelectromechanical solutions for yourmedical/surgical products. Offering turn-keydesign, regulatory, and manufacturingexpertise means no more dropped balls,restarts or finger-pointing - just peace of mindand pure execution.Product FeasibilityProof of ConceptDetailed DesignValidation & Verification Testing13485 ManufacturingPost-Market Surveillance800.562.6204 • www.pro-dex.com ISO 13485:2003-Certified FacilityPro-Dex, Inc., 2361 McGaw Avenue, Irvine, CA 92614 USAVisit us atOMTEC #209

Exhibitor Listing118. Pacific Instruments Inc.438 Hobron Lane, Suite 204Honolulu, HI 96815USA808-941-8880 (phone)808-941-8833 (fax)www.pacificinstruments.bizFounder and President Holger Gruenert, formerly of KMEDIC, startedPacific Instruments in 2005 in his living room and has catapulted thecompany to become a top globally recognized contract manufacturer andprocurement source of orthopedic and custom surgical instruments. Now,equipped with its ISO 13485 certification and well-positioned as a provenplayer in the industry, this year of 2011 marks the company’s debut withthe largest OEMs in the industry and will continue its relentless pursuit tosource them the best surgical instruments while contributing its technicalexpertise in the process.122. PCC Structurals, Inc.4600 SE Harney DrivePortland, OR 97206USA503-652-4643 (phone)503-794-2047 (fax)www.pccstructurals.comPCC’s manufacturing casting technologies have been built up by blendingthe combined knowledge of our highly trained technical staff across morethan 50 years. We have the engineering strength, technical knowledge andmanufacturing resources to support any project whether it is tool design,tool transfer, quick to cast or problem solving a “Barrier to entry” issue onany project. We encourage you to work with PCC Medical and join ourlong lasting tradition of excellence in supporting the medical market castingneeds. ISO 13485 Certified.508. PAK Manufacturing, Inc.704 South 21st StreetIrvington, NJ 07111USA973-372-1090 (phone)973-372-1091 (fax)www.pakmanufacturing.comCustom & Specialty Handheld Surgical Instruments. Hand-finished,forged surgical instruments made in the USA! We specialize in customconfigurations, built from raw forgings (not other instruments). Prototypesoften shipped within 10 days for your approval; production quantitiestypically shipped within 8 weeks. In-house manufacturing capabilitiesinclude milling, grinding, heat treating, passivation, polishing. FDAregistered.620. Piper Plastics, Inc.1840 Enterprise CourtLibertyville, IL 60048USA847-367-0110 (phone)847-367-0566 (fax)www.piperplastics.comPiper Plastics, Inc. is a full service materials processing, machining,fabrication and polymer development company. We offer innovativepolymer-based products and services for medical applications. As anISO 9001:2008 and 13485 certified manufacturer, Piper specializes in highperformance polymers such as implantable and medical grades of PEEK,CF PEEK, PrimoSpire, Ultem and Radel. With facilities in Arizona, Illinois,China and Thailand we support global manufacturing. Solutions in medicalpolymers for orthopedic implants and trials, devices, instruments, imagingcomponents and assemblies.140. Paragon Medical8 Matchett Industrial Park DrivePierceton, IN 46562USA574-594-2140 (phone)41-21-320-37-85 (Europe)574-594-2154 (fax)www.paragonmedical.comParagon Medical is a turnkey supplier of world-class solutions for designand development, cases and trays, surgical instrumentation and implantablecomponents to the medical device marketplace. Headquartered in theorthopaedic capital of the world, Paragon has created strategic centers ofexcellence within the U.S., Europe and Asia. Dynamic acquisitions havebrought some of the industry’s most talented craftsmen to our team whileregional centers of manufacturing excellence have made us more versatile.432. PMC Medical2181 Grand AvenueCincinnati, OH 45214USA513-921-5040 (phone)513-921-5883 (fax)www.pmcsmartsolutions.comPMC Medical is an ISO 13485 certified contract manufacturer of Orthopedicbiomaterial implants and surgical devices. PMC has proprietary processingtechniques for PEEK, bioresorbables and high-temperature thermoplasticmaterials. With over 80 years of experience, PMC’s services includedesign for manufacturability, hyper-precision injection molding, assembly,packaging, and sterilization management. PMC is based in Cincinnati, Ohio,with facilities in Indiana, Mexico and Germany.224. PartMaker540 Pennsylvania Avenue, Suite 315Fort Washington, PA 19034USA215-643-5077 (phone)215-653-0105 (fax)www.partmaker.comPartMaker is the world-leading CAM system for automating theprogramming of multi-axis Turn-Mill centers and Swiss-type lathes.Having pioneered the market in CAM software for multi-axis turning,PartMaker is more experienced and provides the most advancedtechnology in the market today. We work with all multi-spindle, multiaxisand applies a Patented Visual Programming approach to make CNCprogramming quicker and easier.600. PPD Meditech50 RaymondWaterville, Quebec J0B 3H0Canada819-837-2491 (phone)819-837-3083 (fax)www.ppdgroup.comYour medical device outsourcing partner. 100% medical manufacturingfacility. ISO 13485:2003. Proprietary direct compression moldingtechnology and precision dry machining. Prototyping and productionruns. Clean rooms. Molding capabilities: Delrin®, PEEK-Optima®,PEEK continuous strand CF, PLLA, Radel®, UHMWpe, Vit E UHMWpe,e-CIMA/CIMA crosslinked UHMWpe, Ultem®.Page 34

Exhibitor Listing613. Praxis Technology604 Queensbury AvenueQueensbury, NY 12804USA518-812-0112 (phone)518-812-0115 (fax)www.praxisti.comPraxis Technology offers powder titanium to manufacture implants withinnovative features at a significant cost savings. Our tagline is “Leadingthe titanium revolution from powder to parts.” Praxis specializes in TitaniumMetal Injection Molding “TiMIM” for vascular access, cardiac and dentalapplications, and our porous 3DT for ingrowth applications in spine andorthopedics.420. Precision Piece Parts, Inc.712 South Logan StreetMishawaka, IN 46544USA574-255-3185 (phone)574-255-2086 (fax)www.ppp-inc.comInnovative Precision Machining and Outstanding Customer Service since1942. Implant machining since 1991. Five-axis machining, CNC Swissmachining. Extensive bone screw and accessory manufacturing experience.FDA registered. ISO 9001 certified.226. Precision Metal Products850 West Bradley AvenueEl Cajon, CA 92020USA619-448-2711 (phone)619-448-2005 (fax)www.pmp-elcajon.comOrthopaedic Implant Forgings in Titanium, Cobalt-Chrome-Molybdenum,Stainless Steel and Customer Specific Alloys. We are ISO 9001:2000 certified,and our in-house capabilities include heat treating, lab testing, 4-axis and5-axis CNC machining, chemical milling, secondary finishing operationsand complete tool design and fabrication. ISO 9001:2000 certified.209. Pro-Dex Inc.2361 McGaw AvenueIrvine, CA 92614USA949-769-3200 (phone)800-562-6204 (toll-free)949-769-3280 (fax)www.pro-dex.comPro-Dex, Inc. designs, manufactures and assembles powered medicaldevices, motors and motion control products for leading OEMs in themedical, dental, factory automation and scientific research markets. Pro-Dex specializes in manufacturing safe and reliable devices to withstandenvironments where saline, high pH solutions and biomatter are common.As a FDA-registered, 13485-certified manufacturer, Pro-Dex offers fullregulatory support to help get products to market quickly and effectively.Page 35

Exhibitor Listing724. Professional Plastics1810 E. Valencia DriveFullerton, CA 92831USA814-440-1245 (phone)814-864-0082 (fax)www.ProfessionalPlastics.comProfessional Plastics is a global plastic distributor for sheet, rod, tubing,machined and formed parts. Products in our line include: PEEK, Ultem,PTFE, PFA, FEP, Delrin, Nylon, PET, UHMW, Meldin, Evonik PEEK resin,and Solvay Radel resin as well as the Rochling line of Medical Gradematerials to name a few. Visit us on the web at www.ProfessionalPlastics.com.813. Richards Micro Tool250 Cherry StreetPlymouth, MA 02360USA800-233-9956 (toll free)800-642-8665 (fax)www.richardsmicrotool.comRichards Micro Tool, where ingenuity, technology and 45+ years ofexperience combine to provide the finest Rotary Cutting Instruments (drills,taps, reamers, burrs) for leading dental, orthopaedic and neurologicalOEMs. Richards also offers contract manufacturing services & an extensiveline (890+ products) of industrial off-the-shelf cutting tools.630. Promimic ABStena Center 1bGothenburg, SE-412 92Sweden46-31-772-80-22 (phone)www.promimic.comMIMICING HUMAN BONEThe HAnano Surface is an osteoconductive interface between humantissue and implant. The 20nm thin HAnano Surface will dramaticallyaccelerate osseointegration. It can be applied on all implant materials,giving a thin layer of synthetic bone. The surface has excellent compatibilitywith ceramics, metals, pyrocarbon as well as PEEK and can even be appliedon porous structures. Promimic is looking for partners in the global implantindustry.Gold Sponsor212. Rochling Engineering Plastics903 Gastonia Technology ParkwayDallas, NC 28034USA704-884-3506 (phone)www.roechling-plastics.usRöchling Engineering Plastics provides a complete line of Medical Gradeplastics for medical devices, medical instrumentation and orthopedic trialssuch as surgical instruments and devices, orthopedic sizing trials, imagingand monitoring, surgical trays, diagnostic equipment, dental equipmentand devices, pharmaceutical manufacturing and biotechnology. Featuredproducts are SustaPEEK MG, Sustason PPSU MG (Radel® R), SustaPEI MG(Ultem®), Sustarin® C MG Acetal. Röchling offers the following certificates:ASTM, USP Class VI & FDA compliant (as applicable), lot & batchtraceability and ultrasonic testing.124. Pulse Technologies, Inc.2000 AM DriveQuakertown, PA 18951USA267-733-0200 (phone)267-733-0201 (fax)www.pulsetechinc.comWe are an ISO 9001:2000 and ISO 13485:2003 Certified and FDA registeredcontract manufacturer of precision-machined components. Our teamapproach has successfully provided our customers on-time qualityproducts. Capabilities: Swiss screw machining, wire/RAM EDM, CNCmilling, titanium anodizing, wire forming, laser welding/marking andassembly. Materials: platinum, gold, stainless steel, titanium, MP35N,Nitinol. Exotic plastics: PEEK, Radel, Ultem and HDPE.346. Quadrant/MediTECH Medical Polymers2710 American WayFort Wayne, IN 46809USA260-479-4290 (phone)260-478-1074 (fax)www.meditechpolymers.comQuadrant EPP is the world leader in stock shape engineering plasticswith a full line of Life Science products tested for biocompatibility toISO 10993 and USP requirements. Quadrant EPP is the parent companyof MediTECH, the leading supplier for decades to the orthopedicindustry with its UHMW-PE. We work closely with you to anticipateyour future needs while continually searching for ways to exceedyour expectations. Your success and satisfaction is the measure of ourperformance.112. Rolled Alloys125 West Sterns RoadTemperance, MI 48182USA734-847-0561 (phone)800-521-0332 (toll free)734-847-6917 (fax)www.rolledalloys.comRolled Alloys is a premier approved source for titanium and stainless inmedical and aerospace applications. We are certified to ISO 9001:2000 andAS9100 Revision B. We offer Ti 6-4 ELI to the ASTM F136 specification and6-4 to the ASTM F 1472 specification. Rolled Alloys offers 17-4, 300 series,and 400 series. Material is offered in precision ground rod, bar, and plate.Value added processes such as precision saw cutting, water-jet cutting andshearing are all performed on site. Our main focus is on providing qualitymaterial to specifications and providing excellent service.321. Rollomatic, Inc.1295 Amour BoulevardMundelein, IL 60060USA847-281-8550 (phone)847-281-8558 (fax)www.rollomatic.chRollomatic is a leading Swiss manufacturer of CNC grinding machinesserving the medical, industrial and aerospace industries. Our ShapeSmartseries grinders offer the tightest tolerances and highest accuracy forgrinding all manner of cutting tools. We offer unique workholdingapplications and proven solutions for the precision manufacturing ofmedical & dental drills, burs, taps, reamers, shavers and other orthopediccutting tools. With a full range of models to accommodate diameters from0.05 mm – 31.75 mm, Rollomatic has your medical grinding solution.Page 36

CURBELL PLASTICSPlastics for Orthopedic and Medical ApplicationsAVAILABLE MEDICAL-GRADE POLYMERS:• Radel ® R(Sustason PPSU MG)• Acetal (Celcon ® )(Sustarin ® C MG)• Polypropylene(Polystone ® P MG)• PEEK(SustaPEEK MG)• Polysulfone(Sustason PSU MG)• Noryl ®(Susta PPO MG)• Ultem ®(SustaPEI MG)Medical-grade materials complywith agency standards includingUSP Class VI, ISO 10993-5, andFDA, call your Curbell Plasticssales rep for more informationHOW CURBELL PLASTICS CAN BENEFITYOUR BUSINESS:• ISO 9001:2008 quality management system• Lot and batch traceability• Providing paperwork and certifications• Material selection assistance• Technical supportPut us to work – for you! TMCurbell Plastics has been supplying plastic sheet, rod, tube, films, adhesives, sealants, tapes, prototyping and tooling materials, and fabricated parts for over 65 yearsOur medical-grade partnerNATIONWIDE1.888.452.6027www.curbellplastics.com©2011 Curbell Plastics, Inc. All other trademarks and service marks are propertyof their respective manufacturers. MAP1010B 0511

Exhibitor ListingGold Sponsor220. rose plastic, USA LPP.O. Box 698California, PA 15419USA724-938-8530 (phone)724-938-8532 (fax)www.rose-plastic.usrose plastic has offered protective plastic packaging services for 50+ years.The company provides a range of protective plastic packaging for variousapplications, including medical, school, hobby, home, office, cutting toolsand sports. rose plastic’s packaging provides protection during shipping,handling and storage.327. Seabrook International, LLC15 Woodworkers WaySeabrook, NH 03874USA603-474-1919 (phone)603-474-1833 (fax)www.seabrookinternational.comWe Are Dedicated To Our Customers’ Success! Leading contract manufacturerof highly engineered precision instruments, implants and otherdevices for the orthopaedic industry. Seabrook has become an integralsupplier to many of the world’s largest orthopaedic device manufacturersthrough its differentiated approach toward customer service, medical devicequality systems and dedication to true partnerships.519-521. Rosler Metal Finishing1551 Denso RoadBattle Creek, MI 49037USA269-441-3000 (phone)269-441-3001 (fax)www.rosler.usRosler Metal Finishing offers the widest range of surface finishing equipmentin the industry, including mass finishing and shot blasting equipment,media, compounds and effluent treatment. We serve North Americancustomers from our 300,000 sq. ft. manufacturing campus in Battle Creekand support global customers through our worldwide network. Ourcompany slogan “finding a better way...” is exactly what we do. Afterevaluating what the end result should be, our highly-trained employeeschoose from the most extensive product range in the industry to developunbiased, cost-effective solutions. Send us your challenge.614. SHL Automation, Inc.5126 South Royal Atlanta DriveTucker, GA 30084USA770-934-0526 (phone)770-934-3384 (fax)www.shl-automation.comSHL offers the latest innovations in automated surface finishing. Forgrinding, polishing, measuring, brushing, milling, deburring, etc., SHLoffers a customized, turn-key operation. From consulting and designthrough project management, production, programming and training, wedo it all in-house. SHL creates custom solutions that are made to measure.525. RTI International Metals827 Marshall Phelps RoadWindsor, CT 06095USA860-688-8393 (phone)860-683-2337 (fax)www.rtiintl.comRTI International Metals has over 50 years of titanium mill manufacturingexperience and produces the highest quality titanium alloy mill productsavailable. Our U.S. based mill capabilities are complemented by our fullservice U.S. and International distribution operations that can provide ourbiomedical customers 6AL-4V ELI sheet, plate, round and rectangle bar. Inaddition to Titanium, we are a distributor of Nickel, Stainless and AlloySteels with added value capabilities.Platinum Sponsor418. Solvay Specialty Polymers, LLC4500 McGinnis Ferry RoadAlpharetta, GA 30005-3914USA770-772-8580 (phone)800-621-4557 (toll free)770-772-8454 (fax)www.solvayadvancedpolymers.comWe offer more ultra and high-performance medical plastics than any othercompany in the world. This includes Radel R polyphenylsulfone, Udelpolysulfone, PrimoSpire self-reinforced polyphenylene, Ixef polyarylamide,KetaSpire PEEK and AvaSpire modified PEEK. Our polymers can besterilized using all conventional sterilization methods and comply with ISO10993:1 requirements for limited exposure applications.100. SAYAN Orthopaedics Ltd.Karacaoglan MahallesiIsiklar Carsisi, 6172 Sokak No:1/235070 Isikkent/IzmirTurkey90-232-472-27-78/79 (phone)90-232-472-27-76 (fax)www.sayan.com.trSAYAN, highly skilled in orthopaedics, was founded in November 2005to design and manufacture orthopaedic instruments and instrument setsas well as OEM implants by using the knowledge and experience gainedin producing orthopaedic implants for more than 15 years. The companycontinues to operate as a global provider of orthopaedic instruments andimplants on OEM basis.With headquarters in Izmir/Turkiye, SAYANOrthopaedics serves 15 customers in 11 different countries.812. Sonoscan, Inc.2149 E. Pratt BoulevardElk Grove Village, IL 60007USA847-437-6400 (phone)847-437-1550 (fax)www.sonoscan.comSonoscan is a manufacturer of Acoustic Microscope Imaging (AMI)systems for laboratory and production needs, and provides contractanalytical laboratory services. AMI is a nondestructive inspectiontechnique that utilized high-frequency ultrasound to image and detect awide variety of material flaws, defects, and/or failures. The bond qualitybetween materials, such as ceramics, plastics, metals, etc., is easily seen andquantifiable, too. AMI can also be used to characterize or screen a materialprior to further processing.Page 38

Full ServiceFinishing Solutionsfor the Orthopedic Industry• Chrome Plating• Electropolish• Passivation• Heat Treatment• Hand Polishing• Laser Etching• Heavy GrittValidated processesISO 13485 CertfifiedWhen you turn to Finishing Innovations, youturn to the market leader in orthopedic metalfinishing. We specialize in finishing instrumentcomponents to completion for assembly anddelivery to market.We provide superior customer service and quality crasmanshipPut over 60 years of combined orthopedic metal finishing experince to work for youwww.finishinginnovations.comMain: 901-294-2848 / Fax: 901-294-3070 / 578 Hwy 70 / Mason TN, 38049

Exhibitor Listing727. TeroLab Surface SASZI Rue Jean Pierre Timbaud BP 3Villeneuve le Roi, F-94290France33-1-49-61-3434 (Phone)33-1-45-97-0784 (Fax)www.terolabsurface.comSurface engineering, coating and repair solutions. By using modernmanagement techniques and respecting human, environmental and lifefriendlyvalues, TLS is a successful, profitable and high quality internationalenterprise. TLS is a wholly-owned subsidiary of TeroLab Surface. Aninnovator with long experience in coatings for Implantable Medical Devices,we are the partner of choice for the world’s best known manufacturers. Withmore than 900,000 orthopaedic implants coated in more than 20 years ofexcellence, TeroLab Surface SAS has contributed to the success story of thecementless prosthesis, now the leading implant on the world market.324. Titanium Industries18 Green Pond RoadRockaway, MJ 07866USA973-983-6229 (phone)973-983-8015 (fax)www.titanium.comTitanium Mill Products. We are the premier distributor of titanium millproducts used for surgical implant applications. Throughout our titaniumservice center network across the U.S. and Canada, we stock the mostextensive inventory of ASTM specifications of titanium bar, billet, plate,sheet and wire products. ISO 9001:2000 and AS9100A certified.612. TESco Associates500 Business Park DriveTyngsboro, MA 01879USA978-649-5527 (phone)978-649-5529 (fax)www.tescoassociates.com“Your Name is on it, with our reputation built into it!” For a quarter century,TESco Associates has been a leader in absorbable device development andmanufacturing. Let our expertise and state-of-the-art facility work foryou. With proven experience in a wide range of polymers, we take yourdevice from AM-OMTECHalfPageProgram5-10-11.pdf concept to manufacturing. We are ISO 13485:2003 1 5/10/11 certified 11:53 and AMmaintains 12 class 10,000 cleanrooms all devoted to Biomaterials.221. Tornos Technologies840 Parkview BoulevardLombard, IL 60148USA630-812-2040 (phone)630-812-2039 (fax)www.tornos.usSolutions Provider for the Medical Industry. Tornos builds “Swiss” typeturning machines, used in the manufacture of various components frommany medical fields. Components include but are not limited to bonescrews, spinal and dental implants, arthroscopic devices and instruments.Let Tornos review your requirements and work with you to find a solution.CMYCMMYCYCMYKPage 41

Exhibitor Listing527. Total Plastics, Inc.7508 Honeywell DriveFort Wayne, IN 46825USA260-490-3500 (phone)800-288-1444 (toll free)260-490-3600 (fax)www.totalplastics.comWe partner with leading manufacturers, raw material suppliers and relatedindustry resources to bring you the highest level of service and technicalsupport. Specializing in thermoplastics such as acetal copolymer, Ultem,Radel R, UHMWPE (implantable grade), heat stabilized polypropylene,carbon-filled and unfilled grades of PEEK. Recent product offerings includePEEK for long term human implantation. We also offer a complete line ofmedical grade tubing and tape.119. United OrthopedicNo 57 Park Avenue 2Science ParkHsinchu 300Taiwan866-3-577-3351 (phone)866-3-577-7156 (fax)www.uoc.com.twFounded in 1993, the United Orthopedics Corporation (UOC) manufacturesorthopedic implants, instruments and precision medical devices. UOC isone of the only orthopedic manufacturers based in Asia that is fully certifiedby internationally recognized quality standards including cGMP, ISO, CEmark and FDA 510(k). Since 1993, the company has developed a full rangeof prostheses with more than 100,000 successfully implanted worldwide. Inaddition to producing its own branded products, UOC has also served as anOEM supplier for various industry conglomerates.318. Triangle116 Pleasant AvenueUpper Saddle River, NJ 07458USA201-825-1212 (phone)201-236-9814 (fax)www.trianglemfg.comEngineering and Manufacturing Partners for Medical Device Breakthroughs.For 50+ years we have been a customer focused, value-added engineeringand manufacturing partner. Design, development, prototyping and preproductionto volume production to get you from concept to market fasterand more economically. With emphasis on innovative manufacturingsolutions, Triangle achieves the highest quality standards. Registered ISO13485:200321, CFR Part 820 and ISO 9001:2008.714. Universal Precision Instruments, Inc.1120 D.I. DriveElkhart, IN 46514USA574-264-3997 (phone)888-941-3997 (toll-free)574-262-8937 (fax)www.universalpi.comPrecision Machined Instruments, Implants & Guidewires for Orthopedic &Spinal Applications. Providing reliable, respected and high quality contractmanufacturing since 1978. Utilizing state of the market equipment to satisfya wide range of needs including but not limited to Swiss Turning, Multi-Axis Milling, Wire EDM, Laser Etching, Complex Threading, Gundrillingand Metal Finishing.115. Trigon International999-C Remington BoulevardBolingbrook, IL 60440USA630-378-9990 (phone)866-TRIGON3 (toll free)630-378-9991 (fax)www.etrigon.comState of the art manufacturing facilities are only the beginning. Every personat Trigon takes tremendous pride in the quality of our products and servicewe provide to our customers. We are a manufacturer of precision machinedcomponents and assemblies, short runs through high production. Our focusis to be the most highly regarded manufacturing resource to our customers.708. Vistek Medical153 Railroad AvenueIvyland, PA 18974USA215-357-6956 (phone)215-357-3675 (fax)www.vistekmfg.comVistek Medical is an ISO 13485 certified contract manufacturer focusingon partnerships serving the orthopedic and spine markets. Vistek has themachining capability and expertise to support your contract manufacturingneeds across a variety of applications. Whether you need implants forspine, trauma, or extremity applications, Vistek provides the productionexpertise and the customer service to support your program from cradle tograve.726. Twin City EDM and Manufacturing7940 Ranchett Road NortheastFridley, MN 55432USA763-783-7808 (phone)763-783-7842 (fax)www.twincityedm.comWe are a 51-year-old contract manufacturer of precision machined medicalproducts with core competencies of Milling, Swiss Turning, Wire andSinker EDM, Micro-Hole Popping and Laser Marking. We do not makemolds or dies, but piece parts and assemblies. We excel at manufacturingmedical and dental components and surgical instrumentation. Quick-turnprototypes, short-, medium- and high volume manufacturing. Our roboticintegration allows us to run higher volume jobs very competitively in alights-out environment. We provide design for manufacturability adviceand are very good at developing solutions for difficult parts.314. Vulcanium Metals Incorporated3045 Commercial AvenueNorthbrook, IL 60062USA847-498-3111 (phone)888-326-7556 (toll free)847-498-2810 (fax)www.vulcanium.comVulcanium Metals Incorporated carries a full range of medical titanium6AL-4V ELI, 6AL-4V and commercially pure grades of bar, sheet andplate. Our FIRSTCUT+ Services include First-Stage Processing: Water Jet,Cut-to-Length, Laser, Precision Shearing, Sawing, Chamfering, First StageMachining, Deburring and Finishing; Inventory Management - JIT, Kanban;Epak electronic documentation within 24 hours of order shipment; Same/Next Day shipping; Consignment Programs. ISO 9001:2000 Certified. Lean.Page 42

Exhibitor Listing732. Walter (A United Grinding Company)5160 LadLand DriveFredricksburg, VA 22407USA540-898-3700 (phone)540-898-6819 (fax)www.grinding.comWorld leader in grinding machine technology and support. We combine aproven, patented machine design, linear motors, superior coolant deliveryand innovative new software to bring you NXis Ortho: shorter cycle timesfor lowest cost-per-part, whether implants or instruments; a better endproductthat minimizes post-processing; versatility for a wide variety ofcomponents; fast programming and setup; superior support to maximizeup-time and help you adapt to changing requirements.213. ZOLLER Inc.3753 Plaza DriveAnn Arbor, MI 48108USA734-332-4851 (phone)734-332-4852 (fax)www.zoller-usa.comZOLLER’s focus is tool presetting, tool measuring and inspection, and toolmanagement software. Our products are used in factories all over the world.Everywhere you find CNC machines, you will find ZOLLER. Our presetand inspection machines make CNC machines more efficient as a tool’smeasurements can be fully automatically and accurately determined whilethe CNC machine is still running. Accuracy means less waste, less CNCmachine downtime and more profit.Special ThanksA very special thank you to these industry exhibitorswho have been with us from OMTEC 2005to OMTEC 2011. Thank you for your support!Acme Manufacturing Co.Ensinger Inc.FMI Medical Instruments Inc.Ionbond-MedthinMarox Corp.Medin CorporationMetal CraftNewScience InsuranceOnyx Medical Corp.Orchid Orthopedic SolutionsPAK Manufacturing Inc.Paragon Medical Inc.TecometTeleflex Medical OEMVistek MedicalVulcanium Metals Inc.Page 43

Index of Exhibitors by CapabilitiesCastingComponent PartsDelivery SystemsDevice TestingEquipment/MachineryForgingLaser ProcessingImplant/Instrument MachiningProduct Design/Dev/IncubPackaging/SterilizationReg/Clin Affairs/Tech WritingRaw MaterialsSoftware SolutionsSurface Prep/TreatmentsOtherPage 44COUNTRY Booth # COMPANY CA CP DS DT EM FO LP MM PD PS RA RM SO SP OTHERCanada 715 AccelLAB Inc.MM RAUSA 633 Acme Manufacturing Company CP EM MM SPUSA 526 Advantage Manufacturing Technologies, Inc. CP DS LP MM PS SPUSA 430 AeroMed, Inc.MMUSA 424 AIP MM PSTaiwan 720 Alliance Global Technology Co Ltd MMUSA 719 American Express Open OTHERUSA 116 American Tool & Die, Inc. MMUSA 832 APS Materials SPSweden 532 Arcam ABCA EM FO MM PD SPUSA 602 Arwood Machine CorpCP MMUSA 520 ASTRO Medical Devices CP MMUSA 345 Autocam MedicalCP LP MM SPUSA 201 Avalign TechnologiesCP DS MM SPUSA 626 Bob, Incorporated CP MMUSA 712 BodycoteSPUSA 624 Boedeker Plastics Inc.CP RMUSA 127 Bradshaw Medical, Inc. MMUSA 500-501 Branch Medical Group DS MM PSUSA 621 British Standards Institution (BSI) DT RAUSA 515 Brown Precision, Inc. DT MM RAUSA 245 C&A Tool Engineering, Inc. MMNetherlands 142 Cam BioceramicsRM SPChina 731 Canwell Medical Ltd.MM PDUSA 414 CaP Biomaterials, LLCDT RM SPUSA 227 Carpenter Technology Corporation RMUSA 126 Centex Machining, Inc.MMUSA 215 Curbell Plastics, Inc.RMFrance 608 Deloro Stellite GroupCA MM RMKorea 601 Dexcowin Co., LtdEMUSA 421 Donson Machine Co.MMUSA 830 Durr Ecoclean Inc.EM SPUSA 713 Electrolizing Corp. of Ohio, TheMM SPUSA 102 Electropolishing Systems, Inc.LP SPUSA 218 Emerson Consultants, Inc. RAJapan 531 ENDO Manufacturing Co., Ltd MMUSA 125 Ensinger Inc.RMUSA 402 EPTAM Plastics CP MM RMUSA 315 Esprit/DP Technology SOUSA 619 Fairview Machine Company, Inc.MMUSA 733 Finishing Innovations, LLC LP MM SPUSA 415 FMI Medical Instruments CP LP MM PS SPUSA 120 Forecreu America Inc.MM RMUSA 514 Fort Wayne Metals RMSwitzerland 609 GEHRING CUT AG CP MM SPUSA 319 Gibraltar Laboratories DTUSA 246-247 Greatbatch MedicalDS MMUSA 618 gSource, LLCFO MMUSA 320 Hangsterfer's Laboratories Inc.EM FO SPUSA 408 Hansa MedicalCP MM PDUSA 308 Hoosier, Inc. CP LP MM SPUSA 615 Infinity Plastics Group CP MM PD PSUSA 530 In'Tech Medical Inc.MMUSA 625 International Titanium Association RMUSA 518 Ionbond, Inc.SPUSA 326 Jarvis Surgical, Inc. MM SPUSA 109-208 Juno Inc. CP DS PD PSMalaysia 725 Kens Fine MedTech Sdn BhdCP MM PSUSA 200 Knight Mechanical Testing DTUSA 114 LAB Medical Manufacturing, Inc. CP LP MM SPUSA 101 Level 3 Inspection / Smart Inspection Systems DT EM SOCanada 502 Maetta Sciences, Inc.MMUSA 413 Mahar Tool Supply Company, Inc.EMUSA 512 MakinoEMUSA 214 Marketwire OTHERUSA 425-427 Marox CorporationCP MMUSA 312 Medin CorporationDSUSA 513 Medivative TechnologiesCP DS DT MMUSA 509 Metal Craft Machine & Engineering CP LP MM PS SPUSA 826 Micro Machine Company MM PSTaiwan 524 Microware Precision Co., Ltd.CP MM PSUSA 113 Millstone Medical Outsourcing LP PS SO SPUSA 631 Minnesota Rubber & Plastics CP PD

Attendee ResourcesSpeaker PresentationsA selection of OMTEC speakers has agreed to make their presentations available online at www.omtecexpo.com. Presentationswill be available for a limited time. We will remind you of presentation availability via email post-event.Business CenterTo best serve you, a business center is located on the exhibit floor. Most services are complimentary and a hostess is availableto assist you.MealsIn keeping with our mission to help you stay focused on the business at hand, a full hot breakfast will be served both morningsand a complete lunch both afternoons…with catered snacks and beverages in between. Adult beverages and hors d’oeuvreswill be served at the Welcome Reception held on the exhibit floor Wednesday from 4:00pm – 5:30pm.Exhibit Floor HoursWednesday, June 15: 9:00am – 5:30pm (Welcome Reception on the floor from 4:00pm – 5:30pm).Thursday, June 16: 9:00am – 3:00pmKeynotes:Wednesday, June 15: 8:00am – 8:45am (Open to all. Breakfast will be served at 7:30am.)Thursday, June 16: 8:00am – 8:45am (Open to all. Breakfast will be served at 7:30am.)Sessions:Wednesday, June 15: 10:30am – 4:00pm. (Break for catered lunch in Exhibit Hall 12:00pm – 1:30pm)Thursday, June 16: 10:00am – 2:30pm (Break for catered lunch in Exhibit Hall 11:30am – 1:00pm)Need help?Members of the ORTHOWORLD/OMTEC team will always be available at the Registration Area as well as the ORTHOWORLDbooth, 815-819. Hostesses and additional staff will be monitoring the exhibit floor, session rooms, café area and business center.Please let us know how we can be of service to you.Advisory PanelA world-class panel of industry advisors steers BONEZONE toward relevant and timely educational content that is consistent with theneeds of OEM companies. This panel also guides OMTEC’s educational curriculum.Acumed LLCRobert JohnsonDirector of OperationsAlphatec Spine, Inc.Thomas SolowczukDirector, Global SourcingArthrex, Inc.Lance ProvanceSupply Chain ManagerBiomet, Inc.Howard LevyChief Procurement OfficerBiomet, Inc.Troy W. HershbergerVice President of Patient MatchedProductsDePuy Orthopaedics, Inc.Tom CaminoWorldwide Director, Hip ProductDevelopmentDePuy Orthopaedics, Inc.Rod WilsonDirector, Procurement Operations/Business ExcellenceExactech, Inc.Ronald GreenDirector, ManufacturingEngineeringGlobus Medical, Inc.David DavidarVice President, OperationsIntegra LifeSciences Corp.Dale DavisonVice President Engineering, SpineIntegra LifeSciences Corp.John KemnitzerDirector of RegenerativeTechnologies Product DevelopmentK2M, Inc.Rich WoodsSenior Vice President, EngineeringMedtronic Spinal andBiologicsRodney BallardDirector of Product DevelopmentOrtho DevelopmentCorporationBob WestonDirector of OperationsOrthofix, Inc.Paul J. Vasta, Ph.D.Vice President of Research& DevelopmentSmith & NephewOrthopaedics, Inc.Mark HallGlobal Strategic Sourcing ManagerSmith & NephewOrthopaedics, Inc.David D. KelmanGroup Director, Hip DevelopmentStryker Orthopaedics, Inc.Matthew PoggieSenior Director, AppliedTechnologyStryker Orthopaedics, Inc.Kenneth TrimmerSenior Director, AdvancedOperationsTornier, Inc.James KwanVice President, Global SupplyChainWright MedicalTechnology, Inc.Skip FlanneryVice President, Logistics &MaterialsZimmer, Inc.Erin JohnsonVice President, Trauma Research &DevelopmentPage 46

Please visit ourBooth # 432Lecture SpeakerJune 15, at 10:30High PerformanceMedical PlasticPMC, LLC • 2181 Grand Avenue, Cincinnati, Ohio 45214 • USA©2011 PMC. All rights reserved.

Visit us atBooth#140