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Data / Medical devices / Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented / United States

FDA-registered makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented in the United States: 85 establishments

85 establishments in the United States are registered with the FDA to make Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (product code KWS). 25 have a 510(k) clearance or PMA approval on file and 8 have a recall event. FDA data exported November 2, 2026.

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Get makers of this device in the United StatesWatch these makers
Device
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Product code
KWS
Country
United States

Makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Arthrex, Inc.Naples, FL, United StatesSpecification developer17September 26, 2023000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer16April 6, 2026020api.fda.gov
Encore Medical, L.P.Austin, TX, United StatesManufacturer11June 23, 20230110api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer10April 2, 2021040api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer9April 3, 2014000api.fda.gov
Exactech, Inc.Gainesville, FL, United StatesManufacturer8March 4, 2022060api.fda.gov
TORNIER Inc.Columbia City, IN, United StatesSpecification developer8July 22, 2026000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer6December 10, 20210100api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer6March 4, 2003000api.fda.gov
Tornier, Inc.Bloomington, MN, United StatesComplaint file establishment, Manufacturer6July 22, 2026050api.fda.gov
Arthrex Logistic CenterFort Myers, FL, United StatesManufacturer5March 8, 2012000api.fda.gov
Materialise USA, LLC.Plymouth, MI, United StatesManufacturer5July 8, 2019000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer5March 4, 2003000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer, Manufacturer4March 29, 2018000api.fda.gov
Exactech SarasotaSarasota, FL, United StatesManufacturer4December 8, 2011000api.fda.gov
Howmedica Osteonics CorpMahwah, NJ, United StatesContract manufacturer, Contract sterilizer, Manufacturer4March 15, 1999050api.fda.gov
SHOULDER INNOVATIONS, IncGrand Rapids, MI, United StatesRepackager or relabeler, Specification developer3July 5, 2011000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer3February 24, 2020030api.fda.gov
CATALYST ORTHOSCIENCE IncNaples, FL, United StatesManufacturer, Repackager or relabeler, Specification developer2November 6, 2025000api.fda.gov
Arthrosurface, Inc.W Bridgewater, MA, United StatesManufacturer1October 27, 2009000api.fda.gov
E. Bac Si Imports LLCEllensburg, WA, United StatesComplaint file establishment, Specification developer1January 28, 1991000api.fda.gov
Osteoremedies, LLCMemphis, TN, United StatesSpecification developer1December 15, 2015000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesContract manufacturer, Manufacturer1November 22, 2000000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer1November 22, 2000000api.fda.gov
Zimmer Trabecular Metal Technology, Inc.Parsippany, NJ, United StatesManufacturer1June 29, 2007000api.fda.gov
Almark Tool & Manufacturing Company, Inc.Garwood, NJ, United StatesContract manufacturer0000api.fda.gov
Aps Materials, Inc.Dayton, OH, United StatesContract manufacturer0000api.fda.gov
Autocam MedicalKentwood, MI, United StatesContract manufacturer0000api.fda.gov
Advanced Machine, Inc.Winchester, TN, United StatesContract manufacturer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Avalign Delivery Systems DivisionGreenwood, IN, United StatesContract manufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Biopro, Inc.Port Huron, MI, United StatesContract manufacturer0000api.fda.gov
Blue Belt Technologies, Inc.Pittsburgh, PA, United StatesManufacturer0000api.fda.gov
C&A Tool Engineering, Inc. Auburn PlantAuburn, IN, United StatesContract manufacturer0000api.fda.gov
C+a Tool Engineering, Inc.Churubusco, IN, United StatesContract manufacturer0000api.fda.gov
Centex Machining, Inc.Round Rock, TX, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov
Complexus MedicalMishawaka, IN, United StatesContract manufacturer0000api.fda.gov
Depuy Orthopaedics, Inc.Raynham, MA, United StatesManufacturer, Specification developer0000api.fda.gov
Donson Machine CompanyAlsip, IL, United StatesContract manufacturer0000api.fda.gov
Eptam Plastics, LtdNorthfield, NH, United StatesContract manufacturer0000api.fda.gov
Five Star Manufacturing, Inc.New Bedford, MA, United StatesContract manufacturer0000api.fda.gov
Incipio DevicesHuntington, IN, United StatesContract manufacturer0000api.fda.gov
LH Medical CorporationFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
LISI MEDICAL REmmeleBig Lake, MN, United StatesContract manufacturer0000api.fda.gov
LaVezzi Precision, IncBloomingdale, IL, United StatesContract manufacturer0000api.fda.gov
Lincotek Medical LLCVandalia, OH, United StatesContract manufacturer0000api.fda.gov
LinkBio Corp.Dover, NJ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Maitland EngineeringSouth Bend, IN, United StatesContract manufacturer0000api.fda.gov
Micropulse IncColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Mid South PrecisionMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Metal Craft Machine & Engineering, Inc.Elk River, MN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedics-ChelseaChelsea, MI, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedic Solutions Alabama LLCArab, AL, United StatesContract manufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Perryman CompanyHouston, PA, United StatesContract manufacturer0000api.fda.gov
Precision Edge Surgical Products CompanySault Sainte Marie, MI, United StatesContract manufacturer0000api.fda.gov
Pro-Tech Design & MFG., Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov
Paragon Medical - DaytonDayton, OH, United StatesContract manufacturer0000api.fda.gov
Paragon Medical Inc.Castleton, IN, United StatesContract manufacturer0000api.fda.gov
Paragon Medical Inc.Smithfield, UT, United StatesContract manufacturer0000api.fda.gov
Phillips Precision IncElmwood Park, NJ, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, INCStoughton, MA, United StatesContract manufacturer0000api.fda.gov
ProMade PoC Center for Complex Orthopedic Solutions at HSSManhattan, NY, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Rayco Steel Process, Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Restoration Medical PolymersColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Revelation Medical Devices, LLCAuburn, IN, United StatesContract manufacturer0000api.fda.gov
RMS Co.Minneapolis, MN, United StatesContract manufacturer0000api.fda.gov
SCT, Inc.Franklin Lakes, NJ, United StatesContract manufacturer0000api.fda.gov
Single Source Medical LLCChurubusco, IN, United StatesContract manufacturer0000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer0000api.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
Turnco Tool & Instrument, Inc.Georgetown, TX, United StatesContract manufacturer0000api.fda.gov
TriPoint SurgicalColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Trilliant Surgical LLCHouston, TX, United StatesContract manufacturer0000api.fda.gov
Viant Medical, LLCFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
restor3d, inc.Durham, NC, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
rms SurgicalAnoka, MN, 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.