Data / Medical devices / Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) (JDL): 30 FDA-registered makers in 7 countries

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

30 establishments in 7 countries are registered with the FDA to make Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) (product code JDL, Class 3, 21 CFR 888.3320). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 45 510(k) clearances under this code, the latest on August 7, 2008, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: JDL
Device class: 3
Regulation: 888.3320
Medical specialty: Orthopedic
Implant: Yes

Makers by country

Country	Makers
United States	21
China	2
Ireland	2
Japan	2
France	1
United Kingdom	1
Switzerland	1

Makers of Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

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	2	July 1, 1992	0	api.fda.gov
Howmedica Osteonics Corp	Mahwah, NJ, United States	Manufacturer	2	September 20, 1994	2	api.fda.gov
Microport Orthopedics Inc.	Arlington, TN, United States	Manufacturer, Manufacturer for export	2	July 11, 2007	0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Specification developer	1	May 18, 1994	0	api.fda.gov
Depuy Orthopaedics, Inc.	Raynham, MA, United States	Manufacturer	1	May 18, 1994	0	api.fda.gov
Shalby Advanced Technologies, Inc.	El Dorado Hills, CA, United States	Manufacturer	1	July 21, 1993	0	api.fda.gov
Aps Materials, Inc.	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
ARCH - Quakertown	Quakertown, PA, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Seabrook	Seabrook, NH, United States	Contract manufacturer	0		0	api.fda.gov
Avalign Instruments & Implants	Fort Wayne, IN, United States	Contract 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
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou City Jiangsu, China	Manufacturer	0		0	api.fda.gov
Donson Machine Company	Alsip, IL, United States	Contract manufacturer	0		0	api.fda.gov
Howmedica International S. De R.L.	LIMERICK Munster, Ireland	Manufacturer	0		0	api.fda.gov
Himed, LLC	Old Bethpage, NY, 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
KYOCERA Medical Corporation Shiga Higashiomi Plant	Higashiomi-shi Shiga, Japan	Contract manufacturer	0		0	api.fda.gov
KYOCERA Medical Corporation Shiga Yasu Plant	Yasu-shi Shiga, Japan	Contract manufacturer	0		0	api.fda.gov
LH Medical Corporation	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
Lincotek Medical	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
Single Source Medical LLC	Churubusco, IN, United States	Contract manufacturer	0		0	api.fda.gov
Stryker Ireland Osteonics	County Cork, Ireland	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
Vaupell Midwest Molding and Tooling	Constantine, MI, United States	Contract manufacturer	0		0	api.fda.gov
Zimmer GMBH	WINTERTHUR Zurich, Switzerland	Manufacturer	0		0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Manufacturer	0		0	api.fda.gov
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua Zhejiang, China	Manufacturer	0		0	api.fda.gov

Updated August 7, 2008. 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.