Data / Medical devices / Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented (MRA): 17 FDA-registered makers in 4 countries

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

17 establishments in 4 countries are registered with the FDA to make Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented (product code MRA, Class 3). 8 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 8 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: MRA
Device class: 3
Medical specialty: Unknown
Implant: Yes

Makers by country

Country	Makers
United States	11
Ireland	3
Germany	2
China	1

Makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

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	PMA approvals	Recall events	Source
Depuy (ireland)	CO. CORK Munster, Ireland	Manufacturer	1	0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	1	0	api.fda.gov
Depuy Synthes (suzhou) Medical Devices Co., Ltd.	SUZHOU Jiangsu, China	Manufacturer	1	0	api.fda.gov
Depuy Ireland UC	Co. Cork Munster, Ireland	Specification developer	1	0	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Manufacturer	1	2	api.fda.gov
Howmedica Osteonics Corp	Mahwah, NJ, United States	Specification developer	1	1	api.fda.gov
Microport Orthopedics Inc.	Arlington, TN, United States	Manufacturer, Manufacturer for export	1	0	api.fda.gov
Stryker Ireland Osteonics	County Cork, Ireland	Manufacturer	1	0	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Manufacturer for export	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	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
Trigon Incorporated	Mc Murray, PA, United States	Contract manufacturer	0	0	api.fda.gov
Viant AS&O Holdings, LLC	Brimfield, MA, United States	Contract manufacturer	0	0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Manufacturer for export	0	2	api.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.