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

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (JDI): 166 FDA-registered makers in 16 countries

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

166 establishments in 16 countries are registered with the FDA to make Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (product code JDI, Class 2, 21 CFR 888.3350). 51 of them have a 510(k) clearance or PMA approval on file and 13 have a recall event. The FDA has issued 565 510(k) clearances under this code, the latest on August 24, 2026, and lists 76 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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Product code: JDI
Device class: 2
Regulation: 888.3350
Medical specialty: Orthopedic
Implant: Yes

Makers by country

Country	Makers
United States	94
Ireland	11
China	11
Germany	8
Italy	8
Switzerland	7
United Kingdom	6
France	6
Malaysia	5
Taiwan	3
India	2
Australia	1
Belgium	1
South Korea	1
New Zealand	1
San Marino	1

Makers of Prosthesis, Hip, 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
Biomet, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	45	August 24, 2026	15	api.fda.gov
Howmedica Osteonics Corp	Mahwah, NJ, United States	Manufacturer, Specification developer	38	August 2, 2024	18	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer	26	December 17, 2009	2	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Contract manufacturer, Manufacturer, Manufacturer for export	26	July 31, 2025	17	api.fda.gov
Depuy Intl., Ltd.	Leeds, United Kingdom	Contract sterilizer, Manufacturer, Specification developer	19	July 22, 2022	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	19	October 21, 2024	3	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	19	October 21, 2024	0	api.fda.gov
Stryker Ireland Osteonics	County Cork, Ireland	Manufacturer, Specification developer	18	April 12, 2024	0	api.fda.gov
Depuy Synthes (suzhou) Medical Devices Co., Ltd.	SUZHOU Jiangsu, China	Manufacturer	15	July 22, 2022	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	14	June 28, 2013	0	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Manufacturer	13	July 23, 2002	4	api.fda.gov
Microport Orthopedics Inc.	Arlington, TN, United States	Contract manufacturer, Manufacturer, Manufacturer for export	12	January 5, 2022	1	api.fda.gov
Howmedica International S. De R.L.	LIMERICK Munster, Ireland	Manufacturer	11	August 2, 2024	0	api.fda.gov
Depuy Ireland UC	Co. Cork Munster, Ireland	Manufacturer, Specification developer	10	July 22, 2022	0	api.fda.gov
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou City Jiangsu, China	Manufacturer	8	September 29, 2005	0	api.fda.gov
Depuy (ireland)	CO. CORK Munster, Ireland	Manufacturer, Repackager or relabeler, Specification developer	8	April 14, 1998	0	api.fda.gov
Zimmer Manufacturing B.V.	Mercedita, PR, United States	Contract manufacturer, Manufacturer, Manufacturer for export	8	December 10, 2021	2	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	6	October 21, 2024	0	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	Manufacturer	5	June 21, 2005	2	api.fda.gov
Shalby Advanced Technologies, Inc.	El Dorado Hills, CA, United States	Contract manufacturer, Contract sterilizer, Manufacturer	5	April 1, 1996	0	api.fda.gov
Biopro, Inc.	Port Huron, MI, United States	Contract manufacturer, Manufacturer	4	May 22, 2009	2	api.fda.gov
Zimmer Trabecular Metal Technology, Inc.	Parsippany, NJ, United States	Contract manufacturer, Manufacturer	4	August 24, 2000	1	api.fda.gov
Depuy Orthopaedics, Inc.	Raynham, MA, United States	Manufacturer	3	October 17, 1996	0	api.fda.gov
E. Bac Si Imports LLC	Ellensburg, WA, United States	Complaint file establishment, Specification developer	3	May 19, 1993	0	api.fda.gov
Implants Intl. Ltd.	THORNABY-ON-TEES Stockton-on-Tees, United Kingdom	Manufacturer	3	January 28, 2000	0	api.fda.gov
Medacta International SA	Castel San Pietro Ticino, Switzerland	Complaint file establishment, Manufacturer	3	December 29, 2008	0	api.fda.gov
Medacta International SA	Rancate Ticino, Switzerland	Complaint file establishment, Manufacturer	3	December 29, 2008	0	api.fda.gov
Onkos Surgical, Inc.	Parsippany, NJ, United States	Complaint file establishment, Specification developer	3	June 9, 2021	3	api.fda.gov
Ortho Development Corp.	Draper, UT, United States	Complaint file establishment, Manufacturer, Specification developer	3	February 18, 2016	0	api.fda.gov
Corin Limited	CIRENCESTER Gloucestershire, United Kingdom	Manufacturer	2	April 3, 2015	2	api.fda.gov
Signature Orthopaedics Pty Limited	Sydney New South Wales, Australia	Manufacturer	2	March 12, 2026	0	api.fda.gov
Tornier S.A.S.	Montbonnot Saint-Martin Isere, France	Complaint file establishment, Manufacturer	2	July 20, 2000	0	api.fda.gov
Waldemar Link GmbH & Co. KG	Norderstedt Schleswig-Holstein, Germany	Manufacturer	2	February 14, 1996	0	api.fda.gov
Zimmer GMBH	WINTERTHUR Zurich, Switzerland	Contract manufacturer, Manufacturer	2	June 23, 2000	0	api.fda.gov
Aesculap AG	TUTTLINGEN, DONAU Baden-Wurttemberg, Germany	Complaint file establishment, Manufacturer	1	August 2, 2006	0	api.fda.gov
Arthrex, Inc.	Naples, FL, United States	Specification developer	1	June 2, 2008	0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	Manufacturer	1	June 30, 1995	0	api.fda.gov
Globus Medical, Inc.	Memphis, TN, United States	Manufacturer	1	June 30, 1995	0	api.fda.gov
Kyocera Medical Technologies, Inc.	Redlands, CA, United States	Complaint file establishment, Specification developer	1	September 2, 2014	0	api.fda.gov
Materialise N.V.	LEUVEN Vlaams Brabant, Belgium	Manufacturer	1	June 15, 2012	0	api.fda.gov
Maxx Orthopedics Inc.	Norristown, PA, United States	Manufacturer, Specification developer	1	September 28, 2018	0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Specification developer	1	April 27, 2001	0	api.fda.gov
Materialise USA, LLC.	Plymouth, MI, United States	Manufacturer	1	June 15, 2012	0	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer	1	June 28, 2013	0	api.fda.gov
Smith & Nephew Orthopaedics AG	AARAU Aargau, Switzerland	Manufacturer	1	June 28, 2013	0	api.fda.gov
Surgtech, Inc.	Westlake, OH, United States	Manufacturer, Specification developer	1	May 10, 2017	0	api.fda.gov
Signature Orthopaedics Europe Ltd	Athlone Westmeath, Ireland	Manufacturer	1	March 12, 2026	0	api.fda.gov
United Orthopedic Corp.	Kaohsiung, Taiwan	Exporter to the US, Manufacturer	1	January 3, 2020	0	api.fda.gov
United Orthopedic Corporation	Hsinchu Hsinchu(County), Taiwan	Exporter to the US, Manufacturer	1	January 3, 2020	0	api.fda.gov
UOC USA Inc.	Irvine, CA, United States	Manufacturer, Manufacturer for export	1	January 3, 2020	0	api.fda.gov
Warsaw Orthopedic, Inc.	Warsaw, IN, United States	Manufacturer	1	April 27, 2001	0	api.fda.gov
Adler Ortho S.P.A.	Cormano Milano, Italy	Manufacturer	0		0	api.fda.gov
Akshar Gamma Steriles LLP	THANE Maharashtra, India	Contract manufacturer	0		0	api.fda.gov
Almark Tool & Manufacturing Company, Inc.	Garwood, NJ, United States	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, Manufacturer for export	0		0	api.fda.gov
APS Materials Suzhou	Suzhou Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
ARCH - Quakertown	Quakertown, PA, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Memphis	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Memphis	Lexington, TN, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Seabrook	Seabrook, NH, United States	Contract manufacturer	0		0	api.fda.gov
Adler Ortho SpA	Mezzolombardo Trento, Italy	Contract manufacturer	0		0	api.fda.gov
Autocam Medical	Murfreesboro, TN, United States	Contract manufacturer	0		0	api.fda.gov
Avalign Instruments & Implants	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
B-One Medical (suzhou) Co., Ltd.	Suzhou Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
B-One Ortho, Corp.	Cedar Knolls, NJ, United States	Manufacturer	0		0	api.fda.gov
Baechler Feintech AG	Hoelstein Basel-Landschaft, Switzerland	Contract manufacturer	0		0	api.fda.gov
Biocore9 LLC	Denville, NJ, United States	Manufacturer	0		0	api.fda.gov
Biomet France	Valence Drome, France	Manufacturer	0		0	api.fda.gov
Biomet Uk Ltd.	Bridgend, United Kingdom	Specification developer	0		0	api.fda.gov
C&A Tool Engineering, Inc. Auburn Plant	Auburn, IN, United States	Contract manufacturer	0		0	api.fda.gov
C&W Swiss, Inc.	Clayton, OH, 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
Canwell Medical Co., Ltd.	Jinhua Zhejiang, China	Contract manufacturer	0		0	api.fda.gov
Caragh Precision	Galway Galway(County), Ireland	Contract manufacturer	0		0	api.fda.gov
Centex Machining, Inc.	Round Rock, TX, United States	Contract manufacturer	0		0	api.fda.gov
Cep Bio-Coat, LLC	Farmington Hills, MI, United States	Contract manufacturer	0		0	api.fda.gov
CERAMTEC GmbH Medical Products Division	MARKTREDWITZ Bavaria, Germany	Contract manufacturer	0		0	api.fda.gov
CERAMTEC GmbH Medical Products Division	PLOCHINGEN Baden-Wurttemberg, Germany	Contract manufacturer, Contract sterilizer	0		0	api.fda.gov
Corentec Co., Ltd.	Cheonan Si, Chungnam, South Korea	Exporter to the US, Manufacturer	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
Europlaz Technologies Ltd.	Southminster Essex, United Kingdom	Contract manufacturer	0		0	api.fda.gov
Engineered Medical Systems, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
Ferry Machine Corporation	Oakland, NJ, 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
Flex-Cell Precision, Inc.	Lancaster, PA, United States	Contract manufacturer	0		0	api.fda.gov
Frueh Verpackungstechnik AG	Fehraltorf Zurich, Switzerland	Contract manufacturer	0		0	api.fda.gov
Ferry Machine Corporation	Little Ferry, NJ, United States	Contract manufacturer	0		0	api.fda.gov
GB Implantat Technologie GMBH	Bochum North Rhine-Westphalia, Germany	Contract manufacturer	0		0	api.fda.gov
Harwood Design, Inc.	Bristol, PA, United States	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
Hipp Medical AG	Renquishausen Baden-Wurttemberg, Germany	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
Instru-Med Technologies	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Isomedix Operations Inc.	Spartanburg, SC, United States	Contract sterilizer, Manufacturer for export	0		0	api.fda.gov
Ken-Mar Machine MFG Corp	Paterson, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Kammerer Medical Systems GmbH & Co. KG	Stockach Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
LH Medical Corporation	Fort Wayne, IN, 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
Limacorporate S.p.A.	Villanova di San Daniele Udine, Italy	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
Mack Molding Company	Arlington, VT, United States	Contract manufacturer	0		0	api.fda.gov
Mako Surgical Corp.	Weston, FL, United States	Specification developer	0		0	api.fda.gov
Marson Medical, Inc.	Paramus, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Medical Conteneur SAS	SAINT-SOUPPLETS Seine-et-Marne, France	Contract manufacturer	0		0	api.fda.gov
Meril Healthcare Pvt. Ltd.	Vapi Gujarat, India	Manufacturer	0		0	api.fda.gov
Micropulse Inc	Columbia City, IN, 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
Mendell	Lakeville, MN, United States	Contract manufacturer	0		0	api.fda.gov
Metal Craft Machine & Engineering, Inc.	Elk River, MN, United States	Contract manufacturer	0		0	api.fda.gov
MicroPort Orthopedics Global Supply Center Limited	Shanghai, China	Contract manufacturer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC	Olive Branch, MS, United States	Contract manufacturer	0		0	api.fda.gov
NGInstruments, Inc dba Avalign Cutting Instruments	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Norwood Medical LLC	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Nelipak Healthcare Packaging	CLARA, Offaly, Ireland	Contract manufacturer	0		0	api.fda.gov
Oberg Medical Products Company	Sarver, PA, United States	Contract manufacturer	0		0	api.fda.gov
Onyx Medical LLC	Memphis, TN, United States	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
Orchid Orthopedic Solutions Alabama LLC	Arab, AL, United States	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
Precera Medical Herouville SAS	HEROUVILLE ST CLAIR CEDEX Normandie, France	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
Precision Forms, Inc.	Butler, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical - Dayton	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Phillips Precision Inc	Elmwood Park, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Polymer Corporation	Middletown, CT, 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
Rayco Steel Process, Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Riverside Machine & Engineering, Inc.	Eau Claire, WI, United States	Contract manufacturer	0		0	api.fda.gov
SCT, Inc.	Franklin Lakes, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Sferic	MENARS Centre-Val de Loire, France	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
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
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, Inc. - Manchester	Manchester, NH, United States	Contract manufacturer	0		0	api.fda.gov
Syntec Scientific Corp.	CHANG HUA Changhua, Taiwan	Contract manufacturer	0		0	api.fda.gov
Smith and Nephew Operations Sdn. Bhd	Penang Pulau Pinang, Malaysia	Manufacturer	0		0	api.fda.gov
Stryker (Suzhou) Medical Technology Co.,Ltd.	Suzhou Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
Stryker Anngrove	Cork Munster, Ireland	Contract manufacturer	0		0	api.fda.gov
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical Malaysia Sdn Bhd (758243-M)	Bayan Lepas Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
T & L Sharpening, Inc.	Indiana Beach, IN, United States	Contract manufacturer	0		0	api.fda.gov
Takumi Precision Engineering Ltd	Limerick Limerick(County), Ireland	Contract manufacturer	0		0	api.fda.gov
Trigon Incorporated	Mc Murray, PA, United States	Contract manufacturer	0		0	api.fda.gov
Turnco Tool & Instrument, Inc.	Georgetown, TX, United States	Contract manufacturer	0		0	api.fda.gov
Tecomet Inc.	Wilmington, MA, United States	Contract manufacturer	0		0	api.fda.gov
Valtecne SPA	Berbenno di Valtellina Sondrio, Italy	Contract manufacturer	0		0	api.fda.gov
Vaupell Midwest Molding and Tooling	Constantine, MI, United States	Contract manufacturer	0		0	api.fda.gov
Westlake Plastics Europe	TOURCOING Nord, France	Contract manufacturer	0		0	api.fda.gov
Xian Airfoil Technology Co., Ltd.	Xian Shaanxi, China	Contract 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
b-ONE Medical (Beijing) Co., Ltd.	Beijing, China	Contract manufacturer	0		0	api.fda.gov
b-ONE Ortho Corp.	Fairfield, NJ, United States	Specification developer	0		0	api.fda.gov
implantcast GmbH	Buxtehude Lower Saxony, Germany	Complaint file establishment, Manufacturer	0		0	api.fda.gov

Updated August 24, 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.