Data / Medical devices / Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer (KWZ): 119 FDA-registered makers in 15 countries

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

119 establishments in 15 countries are registered with the FDA to make Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer (product code KWZ, Class 2, 21 CFR 888.3310). 17 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 34 510(k) clearances under this code, the latest on July 31, 2025, and lists 8 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: KWZ
Device class: 2
Regulation: 888.3310
Medical specialty: Orthopedic
Implant: Yes

Makers by country

Country	Makers
United States	62
Ireland	8
China	8
France	8
Italy	7
Switzerland	6
United Kingdom	5
Germany	5
Malaysia	4
New Zealand	1
San Marino	1
Belgium	1
Australia	1
Taiwan	1
Poland	1

Makers of Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

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	PMA approvals	Recall events	Source
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	6	April 4, 2024	1	1	api.fda.gov
Howmedica Osteonics Corp	Mahwah, NJ, United States	Manufacturer, Specification developer	6	March 8, 2007	1	1	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	6	June 19, 2017	0	2	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	6	June 19, 2017	0	0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Contract manufacturer, Manufacturer, Specification developer	5	December 3, 2010	0	1	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	4	October 16, 2012	0	0	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	3	January 23, 2003	0	0	api.fda.gov
Depuy Intl., Ltd.	Leeds, United Kingdom	Manufacturer	2	April 4, 2024	1	0	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Manufacturer	3	March 2, 2017	0	1	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer	3	March 3, 2009	0	0	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	Manufacturer	2	July 19, 2007	0	2	api.fda.gov
Depuy Orthopaedics, Inc.	Raynham, MA, United States	Manufacturer	1	April 20, 1987	0	0	api.fda.gov
Depuy Ireland UC	Co. Cork Munster, Ireland	Specification developer	1	April 4, 2024	0	0	api.fda.gov
Medacta International SA	Castel San Pietro Ticino, Switzerland	Complaint file establishment, Manufacturer	1	July 31, 2025	0	0	api.fda.gov
Medacta International SA	Rancate Ticino, Switzerland	Complaint file establishment, Manufacturer	1	July 31, 2025	0	0	api.fda.gov
Stryker Ireland Osteonics	County Cork, Ireland	Manufacturer, Specification developer	1	January 23, 1981	0	0	api.fda.gov
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua Zhejiang, China	Contract manufacturer, Manufacturer	1	January 23, 2003	0	0	api.fda.gov
Accentus Medical Ltd	DIDCOT Oxfordshire, United Kingdom	Contract manufacturer	0		0	0	api.fda.gov
Almark Tool & Manufacturing Company, Inc.	Garwood, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
Aps Materials Inc. Ireland	Waterford Waterford(County), Ireland	Contract manufacturer	0		0	0	api.fda.gov
Aps Materials, Inc.	Dayton, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
APS Materials Suzhou	Suzhou Jiangsu, China	Contract manufacturer	0		0	0	api.fda.gov
ARCH - Quakertown	Quakertown, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Memphis	Bartlett, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Memphis	Lexington, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Seabrook	Seabrook, NH, United States	Contract manufacturer	0		0	0	api.fda.gov
Aristotech Industries GMBH	Luckenwalde Brandenburg, Germany	Contract manufacturer	0		0	0	api.fda.gov
Avalign Instruments & Implants	Fort Wayne, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Baechler Feintech AG	Hoelstein Basel-Landschaft, Switzerland	Contract manufacturer	0		0	0	api.fda.gov
Biomet France	Valence Drome, France	Manufacturer	0		0	0	api.fda.gov
Biomet Uk Ltd.	Bridgend, United Kingdom	Specification developer	0		0	0	api.fda.gov
C&A Tool Engineering, Inc. Auburn Plant	Auburn, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
C&W Swiss, Inc.	Clayton, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
C+a Tool Engineering, Inc.	Churubusco, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Canwell Medical Co., Ltd.	Jinhua Zhejiang, China	Contract manufacturer	0		0	0	api.fda.gov
Caragh Precision	Galway Galway(County), Ireland	Contract manufacturer	0		0	0	api.fda.gov
Centex Machining, Inc.	Round Rock, TX, United States	Contract manufacturer	0		0	0	api.fda.gov
Cep Bio-Coat, LLC	Farmington Hills, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
CERAMTEC GmbH Medical Products Division	MARKTREDWITZ Bavaria, Germany	Contract manufacturer	0		0	0	api.fda.gov
CERAMTEC GmbH Medical Products Division	PLOCHINGEN Baden-Wurttemberg, Germany	Contract manufacturer, Contract sterilizer	0		0	0	api.fda.gov
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou City Jiangsu, China	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Donson Machine Company	Alsip, IL, United States	Contract manufacturer	0		0	0	api.fda.gov
Dot America, Inc.	Columbia City, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Eddi Bressan S.R.L.	CORMONS Gorizia, Italy	Contract manufacturer	0		0	0	api.fda.gov
Enztec Limited	CHRISTCHURCH Canterbury, New Zealand	Contract manufacturer	0		0	0	api.fda.gov
Engineered Medical Systems, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Five Star Manufacturing, Inc.	New Bedford, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
Howmedica International S. De R.L.	LIMERICK Munster, Ireland	Manufacturer	0		0	0	api.fda.gov
HPF S.R.L.	Forgaria nel Friuli Friuli Venezia Giulia, Italy	Contract manufacturer	0		0	0	api.fda.gov
Himed, LLC	Old Bethpage, NY, United States	Contract manufacturer	0		0	0	api.fda.gov
Hipp Medical AG	Renquishausen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	0	api.fda.gov
Innotool&greminger AG	Erlen Thurgau, Switzerland	Contract manufacturer	0		0	0	api.fda.gov
Ken-Mar Machine MFG Corp	Paterson, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
Kammerer Medical Systems GmbH & Co. KG	Stockach Baden-Wurttemberg, Germany	Contract manufacturer	0		0	0	api.fda.gov
LH Medical Corporation	Fort Wayne, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Lincotek (wuxi) Co., Ltd.	Wuxi Jiangsu, China	Contract manufacturer	0		0	0	api.fda.gov
Lincotek Trento S.P.A	Cire di Pergine Trento, Italy	Contract manufacturer	0		0	0	api.fda.gov
LSM-MED S.r.l.	Serravalle San Marino Citta, San Marino	Contract manufacturer	0		0	0	api.fda.gov
Limacorporate S.p.A.	Villanova di San Daniele Udine, Italy	Manufacturer	0		0	0	api.fda.gov
Lincotek Medical LLC	Vandalia, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
Mack Molding Company	Arlington, VT, United States	Contract manufacturer	0		0	0	api.fda.gov
Marle Finishing SAS	La Talaudiere Loire, France	Contract manufacturer	0		0	0	api.fda.gov
Materialise N.V.	LEUVEN Vlaams Brabant, Belgium	Manufacturer	0		0	0	api.fda.gov
Medical Conteneur SAS	SAINT-SOUPPLETS Seine-et-Marne, France	Contract manufacturer	0		0	0	api.fda.gov
Medicoat SAS	ETUPES Bourgogne-Franche-Comte, France	Contract manufacturer	0		0	0	api.fda.gov
Micropulse Inc	Columbia City, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Materialise USA, LLC.	Plymouth, MI, United States	Manufacturer	0		0	0	api.fda.gov
Metal Craft Machine & Engineering, Inc.	Elk River, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Millstone Medical Outsourcing LLC	Olive Branch, MS, United States	Contract manufacturer	0		0	0	api.fda.gov
NGInstruments, Inc dba Avalign Cutting Instruments	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Norwood Medical LLC	Dayton, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
Oberg Medical Products Company	Sarver, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Onyx Medical LLC	Memphis, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Orchid Orthopedics-Chelsea	Chelsea, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Orthoplastics Ltd	Bacup Lancashire, United Kingdom	Contract manufacturer	0		0	0	api.fda.gov
Osteoremedies, LLC	Memphis, TN, United States	Specification developer	0		0	0	api.fda.gov
Orchid Orthopedic Solutions Alabama LLC	Arab, AL, United States	Contract manufacturer	0		0	0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Precera Medical Herouville SAS	HEROUVILLE ST CLAIR CEDEX Normandie, France	Contract manufacturer	0		0	0	api.fda.gov
Precision Edge Surgical Products Company	Sault Sainte Marie, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Paragon Medical Inc.	Castleton, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Phillips Precision Inc	Elmwood Park, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
Polymer Corporation	Middletown, CT, United States	Contract manufacturer	0		0	0	api.fda.gov
Rayco Steel Process, Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Riverside Machine & Engineering, Inc.	Eau Claire, WI, United States	Contract manufacturer	0		0	0	api.fda.gov
SCT, Inc.	Franklin Lakes, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
Serf	DECINES CHARPIEU Rhone, France	Manufacturer	0		0	0	api.fda.gov
Sferic	MENARS Centre-Val de Loire, France	Contract manufacturer	0		0	0	api.fda.gov
Sheffield Precision Medical Ltd	Sheffield, United Kingdom	Contract manufacturer	0		0	0	api.fda.gov
Signature Orthopaedics Pty Limited	Sydney New South Wales, Australia	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Single Source Medical LLC	Churubusco, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Smith & Nephew Orthopaedics AG	AARAU Aargau, Switzerland	Manufacturer	0		0	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		0	0	api.fda.gov
Sti Lualdi S.R.L.	Casiacco Pordenone, Italy	Contract manufacturer	0		0	0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Simpang Ampat Pulau Pinang, Malaysia	Contract manufacturer	0		0	0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Perai Pulau Pinang, Malaysia	Contract manufacturer	0		0	0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Bandar Cassia Pulau Pinang, Malaysia	Contract manufacturer	0		0	0	api.fda.gov
Symmetry Medical Manufacturing Inc	Claypool, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Symmetry Medical, Inc. - Manchester	Manchester, NH, United States	Contract manufacturer	0		0	0	api.fda.gov
Syntec Scientific Corp.	CHANG HUA Changhua, Taiwan	Contract manufacturer	0		0	0	api.fda.gov
Signature Orthopaedics Europe Ltd	Athlone Westmeath, Ireland	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Smith and Nephew Operations Sdn. Bhd	Penang Pulau Pinang, Malaysia	Manufacturer	0		0	0	api.fda.gov
Stryker (Suzhou) Medical Technology Co.,Ltd.	Suzhou Jiangsu, China	Contract manufacturer	0		0	0	api.fda.gov
Stryker Anngrove	Cork Munster, Ireland	Contract manufacturer	0		0	0	api.fda.gov
Stryker Poland Manufacturing Sp. z o.o.	Skawina Malopolskie, Poland	Contract manufacturer	0		0	0	api.fda.gov
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan Jiangsu, China	Contract manufacturer	0		0	0	api.fda.gov
Tecres SPA	VERONA Veneto, Italy	Contract manufacturer	0		0	0	api.fda.gov
Turnco Tool & Instrument, Inc.	Georgetown, TX, United States	Contract manufacturer	0		0	0	api.fda.gov
Valtecne SPA	Berbenno di Valtellina Sondrio, Italy	Contract manufacturer	0		0	0	api.fda.gov
Vaupell Midwest Molding and Tooling	Constantine, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Westlake Plastics Europe	TOURCOING Nord, France	Contract manufacturer	0		0	0	api.fda.gov
Xerxes Arthropedix	Naples, FL, United States	Specification developer	0		0	0	api.fda.gov
Xian Airfoil Technology Co., Ltd.	Xian Shaanxi, China	Contract manufacturer	0		0	0	api.fda.gov
Zimmer GMBH	WINTERTHUR Zurich, Switzerland	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Zimmer Manufacturing B.V.	Mercedita, PR, United States	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Zimmer Orthopedics Manufacturing Limited-Galway	Oranmore Galway(County), Ireland	Contract manufacturer	0		0	0	api.fda.gov
rms Surgical	Anoka, MN, United States	Contract manufacturer	0		0	0	api.fda.gov

Updated July 31, 2025. 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.