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

FDA-registered makers of Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer in the United States: 62 establishments

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

62 establishments in the United States are registered with the FDA to make Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer (product code KWZ). 11 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 2, 2026.

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Device: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Product code: KWZ
Country: United States

Makers of Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer in the United States

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
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
Almark Tool & Manufacturing Company, Inc.	Garwood, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
Aps Materials, Inc.	Dayton, OH, United States	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
Avalign Instruments & Implants	Fort Wayne, IN, United States	Contract manufacturer	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
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
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
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
Himed, LLC	Old Bethpage, NY, United States	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
LH Medical Corporation	Fort Wayne, IN, United States	Contract 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
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
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
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
Single Source Medical LLC	Churubusco, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	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
Turnco Tool & Instrument, Inc.	Georgetown, TX, United States	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
Xerxes Arthropedix	Naples, FL, United States	Specification developer	0		0	0	api.fda.gov
Zimmer Manufacturing B.V.	Mercedita, PR, United States	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
rms Surgical	Anoka, MN, United States	Contract manufacturer	0		0	0	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.