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

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive (PBI): 15 FDA-registered makers in 5 countries

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

15 establishments in 5 countries are registered with the FDA to make Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive (product code PBI, Class 2, 21 CFR 888.3310). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on April 28, 2022, and lists 1 recall event (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.

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

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

Makers by country

Country	Makers
United States	9
China	3
France	1
Canada	1
Ireland	1

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

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	1	November 23, 2012	1	api.fda.gov
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou City Jiangsu, China	Manufacturer	1	November 23, 2012	0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Contract manufacturer, Manufacturer, Specification developer	1	April 28, 2022	0	api.fda.gov
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua Zhejiang, China	Contract manufacturer, Manufacturer	1	November 23, 2012	0	api.fda.gov
Aps Materials, Inc.	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
APS Materials Suzhou	Suzhou Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
Donson Machine Company	Alsip, IL, 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
Micropulse Inc	Columbia City, IN, United States	Contract manufacturer	0		0	api.fda.gov
Single Source Medical LLC	Churubusco, IN, United States	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
Zimmer Cas	Montreal, Quebec, Canada	Manufacturer	0		0	api.fda.gov
Zimmer Manufacturing B.V.	Mercedita, PR, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Zimmer Orthopedics Manufacturing Limited-Galway	Oranmore Galway(County), Ireland	Contract manufacturer	0		0	api.fda.gov

Updated April 28, 2022. 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.