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

FDA-registered makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented in the United States: 94 establishments

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

94 establishments in the United States are registered with the FDA to make Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (product code JDI). 30 have a 510(k) clearance or PMA approval on file and 12 have a recall event. 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 makers of this device in the United States Watch these makers

Device: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Product code: JDI
Country: United States

Makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented in the United States

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
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
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
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
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
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
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
Surgtech, Inc.	Westlake, OH, United States	Manufacturer, Specification developer	1	May 10, 2017	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
Almark Tool & Manufacturing Company, Inc.	Garwood, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Aps Materials, Inc.	Dayton, OH, United States	Contract manufacturer, Manufacturer for export	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
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 Ortho, Corp.	Cedar Knolls, NJ, United States	Manufacturer	0		0	api.fda.gov
Biocore9 LLC	Denville, NJ, United States	Manufacturer	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
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
Donson Machine Company	Alsip, IL, United States	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
Ferry Machine Corporation	Little Ferry, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Harwood Design, Inc.	Bristol, PA, United States	Contract manufacturer	0		0	api.fda.gov
Incipio Devices	Huntington, IN, United States	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
LH Medical Corporation	Fort Wayne, IN, United States	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
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
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
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
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
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
Symmetry Medical, Inc. - Manchester	Manchester, NH, United States	Contract manufacturer	0		0	api.fda.gov
T & L Sharpening, Inc.	Indiana Beach, IN, United States	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
Vaupell Midwest Molding and Tooling	Constantine, MI, United States	Contract manufacturer	0		0	api.fda.gov
b-ONE Ortho Corp.	Fairfield, NJ, United States	Specification developer	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.