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Data / Medical devices / Prosthesis, Elbow, Hemi-, Radial, Polymer / United States

FDA-registered makers of Prosthesis, Elbow, Hemi-, Radial, Polymer in the United States: 63 establishments

63 establishments in the United States are registered with the FDA to make Prosthesis, Elbow, Hemi-, Radial, Polymer (product code KWI). 14 have a 510(k) clearance or PMA approval on file and 7 have a recall event. FDA data exported November 2, 2026.

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Device
Prosthesis, Elbow, Hemi-, Radial, Polymer
Product code
KWI
Country
United States

Makers of Prosthesis, Elbow, Hemi-, Radial, Polymer in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer4April 19, 2006010api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer4April 19, 2006020api.fda.gov
Skeletal Dynamics, IncMiami, FL, United StatesComplaint file establishment, Repackager or relabeler, Specification developer3September 28, 2023010api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer, Manufacturer for export3April 16, 2004000api.fda.gov
Acumed LLCHillsboro, OR, United StatesManufacturer2September 30, 2013010api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer2August 5, 2005020api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer2May 17, 2019020api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer1July 30, 2026000api.fda.gov
Biopoly, LLCFort Wayne, IN, United StatesManufacturer1March 13, 2024000api.fda.gov
Howmedica Osteonics CorpMahwah, NJ, United StatesSpecification developer1June 19, 2001010api.fda.gov
Kapp Surgical, Inc.Cleveland, OH, United StatesManufacturer, Specification developer1August 29, 2003000api.fda.gov
Medartis Inc.Warsaw, IN, United StatesSpecification developer1January 7, 2020000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer1February 25, 2000000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer1February 25, 2000000api.fda.gov
Axial MedicalIvyland, PA, United StatesContract manufacturer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
B & G MFG. Co.Hatfield, PA, United StatesContract manufacturer0000api.fda.gov
Banister Tool, Inc.Pflugerville, TX, United StatesContract manufacturer0000api.fda.gov
Branch Medical GroupEagleville, PA, United StatesContract manufacturer0000api.fda.gov
Branch Medical GroupLimerick, PA, United StatesContract manufacturer0000api.fda.gov
Bradshaw Medical Inc.Kenosha, WI, United StatesContract manufacturer0000api.fda.gov
C&W Swiss, Inc.Clayton, OH, United StatesContract manufacturer0000api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer0000api.fda.gov
Ferry Machine CorporationOakland, NJ, United StatesContract manufacturer0000api.fda.gov
First Article IncSouderton, PA, United StatesContract manufacturer0000api.fda.gov
Flex-Cell Precision, Inc.Lancaster, PA, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationLittle Ferry, NJ, United StatesContract manufacturer0000api.fda.gov
Gauthier Biomedical, Inc.Grafton, WI, United StatesContract manufacturer0000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
J & J Precision Technologies, LLCLititz, PA, United StatesContract manufacturer0000api.fda.gov
J&B Precision, Inc.Cordova, TN, United StatesContract manufacturer0000api.fda.gov
Jatex, Inc.Nappanee, IN, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Lincotek MedicalBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Mach MedicalColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Maitland EngineeringSouth Bend, IN, United StatesContract manufacturer0000api.fda.gov
Medical Device And Implants LLCLancaster, PA, United StatesContract manufacturer0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer0000api.fda.gov
Micropulse IncColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
MSK Precision Products, Inc.Tamarac, FL, United StatesContract manufacturer0000api.fda.gov
Metal Craft Machine & Engineering, Inc.Elk River, MN, United StatesContract manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
On-X Life Technologies Inc.Austin, TX, United StatesManufacturer for export0000api.fda.gov
Pacific Instruments Inc.Honolulu, HI, United StatesContract manufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, INCStoughton, MA, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Riverside Machine & Engineering, Inc.Eau Claire, WI, United StatesContract manufacturer0000api.fda.gov
RMS Co.Minneapolis, MN, United StatesContract manufacturer0000api.fda.gov
Single Source Medical LLCChurubusco, IN, United StatesContract manufacturer0000api.fda.gov
Structure Medical, LLC.Naples, FL, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Structure Medical, LLC.Mooresville, NC, United StatesContract manufacturer0000api.fda.gov
TecometWoburn, MA, United StatesContract manufacturer0000api.fda.gov
Turnco Tool & Instrument, Inc.Georgetown, TX, United StatesContract manufacturer0000api.fda.gov
Viant AS&O Holdings, LLCOrchard Park, NY, United StatesContract manufacturer0000api.fda.gov
Viant Upland, IncUpland, CA, United StatesContract manufacturer0000api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.