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

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (KWS): 160 FDA-registered makers in 20 countries

Name: FDA-registered makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

160 establishments in 20 countries are registered with the FDA to make Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (product code KWS, Class 2, 21 CFR 888.3660). 44 of them have a 510(k) clearance or PMA approval on file and 11 have a recall event. The FDA has issued 191 510(k) clearances under this code, the latest on July 22, 2026, and lists 52 recall events (0 Class I). FDA data exported November 2, 2026.

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Get every maker of this device Makers in the United States Watch this device

Product code: KWS
Device class: 2
Regulation: 888.3660
Medical specialty: Orthopedic
Implant: Yes

Makers by country

Country	Makers
United States	85
France	10
Switzerland	10
Italy	9
Germany	8
Ireland	7
China	6
United Kingdom	6
Malaysia	5
Belgium	2
Canada	2
Australia	2
Ukraine	1
Poland	1
India	1
New Zealand	1
Argentina	1
San Marino	1
Colombia	1
Taiwan	1

Makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Arthrex, Inc.	Naples, FL, United States	Specification developer	17	September 26, 2023	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	16	April 6, 2026	2	api.fda.gov
Tornier S.A.S.	Montbonnot Saint-Martin Isere, France	Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Specification developer	16	June 12, 2019	0	api.fda.gov
Arthrex GmbH	Munich Bavaria, Germany	Exporter to the US, Specification developer	11	June 7, 2021	0	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Manufacturer	11	June 23, 2023	11	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	10	April 2, 2021	4	api.fda.gov
DePuy Mitek, Inc.	Raynham, MA, United States	Specification developer	9	April 3, 2014	0	api.fda.gov
Limacorporate S.p.A.	Villanova di San Daniele Udine, Italy	Manufacturer	9	May 13, 2022	1	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	Manufacturer	8	March 4, 2022	6	api.fda.gov
TORNIER Inc.	Columbia City, IN, United States	Specification developer	8	July 22, 2026	0	api.fda.gov
Stryker Macroom	Co Cork Munster, Ireland	Contract manufacturer, Manufacturer	7	June 10, 2016	0	api.fda.gov
Zimmer GMBH	WINTERTHUR Zurich, Switzerland	Manufacturer	7	March 8, 2016	1	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Manufacturer	6	December 10, 2021	10	api.fda.gov
STRYKER GmbH	SELZACH Solothurn, Switzerland	Complaint file establishment, Specification developer	6	September 3, 2021	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	6	March 4, 2003	0	api.fda.gov
Tornier S.A.S	Montbonnot Saint-Martin Isere, France	Complaint file establishment, Contract manufacturer, Manufacturer	6	June 12, 2019	0	api.fda.gov
Tornier, Inc.	Bloomington, MN, United States	Complaint file establishment, Manufacturer	6	July 22, 2026	5	api.fda.gov
Arthrex Logistic Center	Fort Myers, FL, United States	Manufacturer	5	March 8, 2012	0	api.fda.gov
Materialise N.V.	LEUVEN Vlaams Brabant, Belgium	Manufacturer	5	July 8, 2019	1	api.fda.gov
Materialise USA, LLC.	Plymouth, MI, United States	Manufacturer	5	July 8, 2019	0	api.fda.gov
Materialise Ukraine, Rep. office	Kyiv Kyyiv, Misto, Ukraine	Manufacturer	5	July 8, 2019	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	5	March 4, 2003	0	api.fda.gov
Arthrex Manufacturing Inc.	Pendleton, SC, United States	Contract manufacturer, Contract sterilizer, Manufacturer	4	March 29, 2018	0	api.fda.gov
Depuy (ireland)	CO. CORK Munster, Ireland	Manufacturer, Specification developer	4	April 2, 2021	0	api.fda.gov
Depuy Synthes (suzhou) Medical Devices Co., Ltd.	SUZHOU Jiangsu, China	Manufacturer	4	April 3, 2014	0	api.fda.gov
Exactech Sarasota	Sarasota, FL, United States	Manufacturer	4	December 8, 2011	0	api.fda.gov
Howmedica Osteonics Corp	Mahwah, NJ, United States	Contract manufacturer, Contract sterilizer, Manufacturer	4	March 15, 1999	5	api.fda.gov
Imascap	PLOUZANE Finistere, France	Specification developer	4	February 22, 2017	0	api.fda.gov
Materialise Sdn Bhd	Petaling Jaya Selangor, Malaysia	Manufacturer	4	July 8, 2019	0	api.fda.gov
Depuy Ireland UC	Co. Cork Munster, Ireland	Manufacturer, Specification developer	3	April 3, 2014	0	api.fda.gov
SHOULDER INNOVATIONS, Inc	Grand Rapids, MI, United States	Repackager or relabeler, Specification developer	3	July 5, 2011	0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Contract manufacturer, Manufacturer	3	February 24, 2020	3	api.fda.gov
CATALYST ORTHOSCIENCE Inc	Naples, FL, United States	Manufacturer, Repackager or relabeler, Specification developer	2	November 6, 2025	0	api.fda.gov
Medacta International SA	Castel San Pietro Ticino, Switzerland	Complaint file establishment, Manufacturer	2	January 30, 2025	0	api.fda.gov
Medacta International SA	Rancate Ticino, Switzerland	Complaint file establishment, Manufacturer	2	January 30, 2025	0	api.fda.gov
Arthrosurface, Inc.	W Bridgewater, MA, United States	Manufacturer	1	October 27, 2009	0	api.fda.gov
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou City Jiangsu, China	Contract manufacturer, Manufacturer	1	June 4, 2004	0	api.fda.gov
E. Bac Si Imports LLC	Ellensburg, WA, United States	Complaint file establishment, Specification developer	1	January 28, 1991	0	api.fda.gov
FH Industrie	QUIMPER Finistere, France	Manufacturer	1	November 24, 2010	0	api.fda.gov
Osteoremedies, LLC	Memphis, TN, United States	Specification developer	1	December 15, 2015	0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Contract manufacturer, Manufacturer	1	November 22, 2000	0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Complaint file establishment, Specification developer	1	November 22, 2000	0	api.fda.gov
Zimmer Cas	Montreal, Quebec, Canada	Manufacturer, Specification developer	1	August 20, 2013	0	api.fda.gov
Zimmer Trabecular Metal Technology, Inc.	Parsippany, NJ, United States	Manufacturer	1	June 29, 2007	0	api.fda.gov
3d-Side	Mont Saint Guibert Brabant Wallon, Belgium	Manufacturer	0		0	api.fda.gov
Accentus Medical Ltd	DIDCOT Oxfordshire, United Kingdom	Contract manufacturer	0		0	api.fda.gov
Almark Tool & Manufacturing Company, Inc.	Garwood, NJ, United States	Contract manufacturer	0		0	api.fda.gov
AMETEK Poland sp. z o.o.	Siechnice Dolnoslaskie, Poland	Contract manufacturer	0		0	api.fda.gov
Aps Materials Inc. Ireland	Waterford Waterford(County), Ireland	Contract manufacturer	0		0	api.fda.gov
Aps Materials, Inc.	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Autocam Medical	Kentwood, MI, United States	Contract manufacturer	0		0	api.fda.gov
Automatics Tooling Company Ltd	Salfords Surrey, United Kingdom	Contract manufacturer	0		0	api.fda.gov
Advanced Machine, Inc.	Winchester, TN, United States	Contract manufacturer	0		0	api.fda.gov
Arthrex, Inc.	Ave Maria, FL, United States	Contract manufacturer, Contract sterilizer	0		0	api.fda.gov
Autocam Medical	Murfreesboro, TN, United States	Contract manufacturer	0		0	api.fda.gov
Avalign Delivery Systems Division	Greenwood, IN, United States	Contract manufacturer	0		0	api.fda.gov
Avalign Instruments & Implants	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
Baechler Feintech AG	Hoelstein Basel-Landschaft, Switzerland	Contract manufacturer	0		0	api.fda.gov
BBC Cellpack Technology AG	Villmergen Aargau, Switzerland	Contract manufacturer	0		0	api.fda.gov
Biocomposites Ltd.	Keele Staffordshire, United Kingdom	Specification developer	0		0	api.fda.gov
Biopro, Inc.	Port Huron, MI, United States	Contract manufacturer	0		0	api.fda.gov
Blue Belt Technologies, Inc.	Pittsburgh, PA, United States	Manufacturer	0		0	api.fda.gov
C&A Tool Engineering, Inc. Auburn Plant	Auburn, IN, United States	Contract manufacturer	0		0	api.fda.gov
C+a Tool Engineering, Inc.	Churubusco, IN, United States	Contract manufacturer	0		0	api.fda.gov
Cefimeca	La Talaudiere Loire, France	Contract manufacturer	0		0	api.fda.gov
Centex Machining, Inc.	Round Rock, TX, United States	Contract manufacturer, Manufacturer for export	0		0	api.fda.gov
Chlorophyllic Concepts (opc) Private Limited	Thane Maharashtra, India	Contract manufacturer	0		0	api.fda.gov
Complexus Medical	Mishawaka, IN, United States	Contract manufacturer	0		0	api.fda.gov
Depuy Intl., Ltd.	Leeds, United Kingdom	Manufacturer	0		0	api.fda.gov
Depuy Orthopaedics, Inc.	Raynham, MA, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Donson Machine Company	Alsip, IL, United States	Contract manufacturer	0		0	api.fda.gov
Eddi Bressan S.R.L.	CORMONS Gorizia, Italy	Contract manufacturer	0		0	api.fda.gov
Enztec Limited	CHRISTCHURCH Canterbury, New Zealand	Contract manufacturer	0		0	api.fda.gov
Eptam Plastics, Ltd	Northfield, NH, United States	Contract manufacturer	0		0	api.fda.gov
Five Star Manufacturing, Inc.	New Bedford, MA, United States	Contract manufacturer	0		0	api.fda.gov
Friedrich Daniels GMBH	SOLINGEN North Rhine-Westphalia, Germany	Contract manufacturer	0		0	api.fda.gov
Frueh Verpackungstechnik AG	Fehraltorf Zurich, Switzerland	Contract manufacturer	0		0	api.fda.gov
G21 S.R.I.	San Possidonio Modena, Italy	Complaint file establishment, Manufacturer	0		0	api.fda.gov
GB Implantat Technologie GMBH	Bochum North Rhine-Westphalia, Germany	Contract manufacturer	0		0	api.fda.gov
HPF S.R.L.	Forgaria nel Friuli Friuli Venezia Giulia, Italy	Contract manufacturer	0		0	api.fda.gov
Incipio Devices	Huntington, IN, United States	Contract manufacturer	0		0	api.fda.gov
Innotool&greminger AG	Erlen Thurgau, Switzerland	Contract manufacturer	0		0	api.fda.gov
Kico Knee Innovation Company	Frenchs Forest New South Wales, Australia	Manufacturer	0		0	api.fda.gov
Kammerer Medical Systems GmbH & Co. KG	Stockach Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Laboratorios SL SA	Malvinas Argentinas Buenos Aires, Argentina	Contract manufacturer	0		0	api.fda.gov
LH Medical Corporation	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
LISI MEDICAL REmmele	Big Lake, MN, United States	Contract manufacturer	0		0	api.fda.gov
LSM-MED S.r.l.	Serravalle San Marino Citta, San Marino	Contract manufacturer	0		0	api.fda.gov
LaVezzi Precision, Inc	Bloomingdale, IL, United States	Contract manufacturer	0		0	api.fda.gov
Limacorporate S.p.A.	Calatafimi Segesta (TP) Sicilia, Italy	Contract manufacturer	0		0	api.fda.gov
Lincotek Medical LLC	Vandalia, OH, United States	Contract manufacturer	0		0	api.fda.gov
LinkBio Corp.	Dover, NJ, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Maitland Engineering	South Bend, IN, United States	Contract manufacturer	0		0	api.fda.gov
Marle Finishing SAS	La Talaudiere Loire, France	Contract manufacturer	0		0	api.fda.gov
Micropulse Inc	Columbia City, IN, United States	Contract manufacturer	0		0	api.fda.gov
Mid South Precision	Murfreesboro, TN, United States	Contract manufacturer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0		0	api.fda.gov
Moser-Baer AG	Sumiswald Bern, Switzerland	Contract manufacturer	0		0	api.fda.gov
Materialise Colombia S.A.S	Medellin Antioquia, Colombia	Manufacturer	0		0	api.fda.gov
Metal Craft Machine & Engineering, Inc.	Elk River, MN, United States	Contract manufacturer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC	Olive Branch, MS, United States	Contract manufacturer	0		0	api.fda.gov
Oeb S.R.L.	Camposanto Modena, Italy	Contract manufacturer	0		0	api.fda.gov
Orchid Orthopedics-Chelsea	Chelsea, MI, United States	Contract manufacturer	0		0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0		0	api.fda.gov
Orthoplastics Ltd	Bacup Lancashire, United Kingdom	Contract manufacturer	0		0	api.fda.gov
Osartis GMBH	Muenster Hesse, Germany	Specification developer	0		0	api.fda.gov
Orchid Orthopedic Solutions Alabama LLC	Arab, AL, United States	Contract manufacturer	0		0	api.fda.gov
Ortho Solutions Sdn Bhd	Prai, Penang Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0		0	api.fda.gov
Perryman Company	Houston, PA, United States	Contract manufacturer	0		0	api.fda.gov
PPD Meditech, Div. Of Industries PPD Inc.	Waterville Quebec, Canada	Contract manufacturer	0		0	api.fda.gov
Precera Medical Herouville SAS	HEROUVILLE ST CLAIR CEDEX Normandie, France	Contract manufacturer	0		0	api.fda.gov
Precision Ai Pty Ltd	Brisbane Queensland, Australia	Contract manufacturer	0		0	api.fda.gov
Precision Edge Surgical Products Company	Sault Sainte Marie, MI, United States	Contract manufacturer	0		0	api.fda.gov
Pro-Tech Design & MFG., Inc.	Santa Fe Springs, CA, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical - Dayton	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
Paragon Medical Inc.	Castleton, IN, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical Inc.	Smithfield, UT, United States	Contract manufacturer	0		0	api.fda.gov
Phillips Precision Inc	Elmwood Park, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Primo Medical Group, INC	Stoughton, MA, United States	Contract manufacturer	0		0	api.fda.gov
ProMade PoC Center for Complex Orthopedic Solutions at HSS	Manhattan, NY, United States	Contract manufacturer	0		0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0		0	api.fda.gov
Rayco Steel Process, Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Restoration Medical Polymers	Columbia City, IN, United States	Contract manufacturer	0		0	api.fda.gov
Revelation Medical Devices, LLC	Auburn, IN, United States	Contract manufacturer	0		0	api.fda.gov
RMS Co.	Minneapolis, MN, United States	Contract manufacturer	0		0	api.fda.gov
SCT, Inc.	Franklin Lakes, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Sheffield Precision Medical Ltd	Sheffield, United Kingdom	Contract manufacturer	0		0	api.fda.gov
Single Source Medical LLC	Churubusco, IN, United States	Contract manufacturer	0		0	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer	0		0	api.fda.gov
SQ Products AG	Inwil Luzern, Switzerland	Contract manufacturer	0		0	api.fda.gov
Sti Lualdi S.R.L.	Casiacco Pordenone, Italy	Contract manufacturer	0		0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Simpang Ampat Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Perai Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Bandar Cassia Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
Stryker Ireland Osteonics	County Cork, Ireland	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical Manufacturing Inc	Claypool, IN, United States	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical Polyvac SAS	WAMBRECHIES Nord, France	Contract manufacturer	0		0	api.fda.gov
Syntec Scientific Corp.	CHANG HUA Changhua, Taiwan	Contract manufacturer	0		0	api.fda.gov
Structure Medical, LLC.	Mooresville, NC, United States	Contract manufacturer	0		0	api.fda.gov
Stryker Anngrove	Cork Munster, Ireland	Contract manufacturer	0		0	api.fda.gov
Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd.	Changzhou, Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
Stryker Trauson (Changzhou) Medical Technology Co., Ltd.	Changzhou City Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
Tecres SPA	VERONA Veneto, Italy	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Tontarra Medizintechnik GMBH	WURMLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Turnco Tool & Instrument, Inc.	Georgetown, TX, United States	Contract manufacturer	0		0	api.fda.gov
TriPoint Surgical	Columbia City, IN, United States	Contract manufacturer	0		0	api.fda.gov
Trilliant Surgical LLC	Houston, TX, United States	Contract manufacturer	0		0	api.fda.gov
Valtecne SPA	Berbenno di Valtellina Sondrio, Italy	Contract manufacturer	0		0	api.fda.gov
Viant Chaumont S.A.S.	CHAUMONT Haute-Marne, France	Contract manufacturer	0		0	api.fda.gov
Viant Medical, LLC	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
W+S Solutions GMBH	Tuttlingen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Westlake Plastics Europe	TOURCOING Nord, France	Contract manufacturer	0		0	api.fda.gov
Waldemar Link GmbH & Co. KG	Norderstedt Schleswig-Holstein, Germany	Manufacturer	0		0	api.fda.gov
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua Zhejiang, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Zimmer Orthopedics Manufacturing Limited-Galway	Oranmore Galway(County), Ireland	Contract manufacturer	0		0	api.fda.gov
restor3d, inc.	Durham, NC, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
rms Surgical	Anoka, MN, United States	Contract manufacturer	0		0	api.fda.gov

Updated July 22, 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.