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

FDA-registered makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer in the United States: 137 establishments

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

137 establishments in the United States are registered with the FDA to make Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (product code JWH). 38 have a 510(k) clearance or PMA approval on file and 16 have a recall event. FDA data exported November 3, 2026.

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Device: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Product code: JWH
Country: United States

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

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Class I	Source
Zimmer, Inc.	Warsaw, IN, United States	Contract manufacturer, Manufacturer, Manufacturer for export	61	March 6, 2025	47	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	51	April 2, 2025	21	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	51	April 2, 2025	0	0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer	46	August 25, 2021	17	1	api.fda.gov
Microport Orthopedics Inc.	Arlington, TN, United States	Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Reprocessor	44	February 18, 2025	1	0	api.fda.gov
Howmedica Osteonics Corp	Mahwah, NJ, United States	Contract manufacturer, Contract sterilizer, Manufacturer, Specification developer	43	February 6, 2025	36	0	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Manufacturer	40	July 28, 2017	33	0	api.fda.gov
Depuy Orthopaedics, Inc.	Raynham, MA, United States	Manufacturer, Manufacturer for export	30	September 4, 2026	0	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	30	April 26, 2022	0	0	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	Manufacturer	29	July 17, 2023	18	0	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Complaint file establishment, Manufacturer, Specification developer	27	July 2, 2025	33	0	api.fda.gov
UOC USA Inc.	Irvine, CA, United States	Manufacturer, Manufacturer for export	20	September 25, 2025	0	0	api.fda.gov
ConforMIS, Inc.	Wilmington, MA, United States	Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor	18	April 27, 2023	1	0	api.fda.gov
Exactech Sarasota	Sarasota, FL, United States	Manufacturer	17	April 28, 2017	0	0	api.fda.gov
Ortho Development Corp.	Draper, UT, United States	Complaint file establishment, Manufacturer, Specification developer	15	October 25, 2024	0	0	api.fda.gov
Total Joint Orthopedics, Inc.	Salt Lake City, UT, United States	Complaint file establishment, Specification developer	15	July 23, 2026	0	0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	Manufacturer	14	July 31, 2026	5	0	api.fda.gov
Globus Medical, Inc.	Memphis, TN, United States	Manufacturer	13	July 31, 2026	0	0	api.fda.gov
Maxx Orthopedics Inc.	Norristown, PA, United States	Complaint file establishment, Manufacturer, Specification developer	13	October 22, 2025	0	0	api.fda.gov
Materialise USA, LLC.	Plymouth, MI, United States	Manufacturer	13	January 6, 2026	3	0	api.fda.gov
Shalby Advanced Technologies, Inc.	El Dorado Hills, CA, United States	Contract manufacturer, Contract sterilizer, Manufacturer	13	January 14, 2025	0	0	api.fda.gov
OMNIlifeScience, Inc.	Raynham, MA, United States	Manufacturer, Specification developer	12	April 2, 2021	2	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	9	August 13, 2012	4	0	api.fda.gov
Zimmer Trabecular Metal Technology, Inc.	Parsippany, NJ, United States	Manufacturer	9	September 5, 2019	1	0	api.fda.gov
B-One Ortho, Corp.	Cedar Knolls, NJ, United States	Manufacturer, Specification developer	6	October 6, 2022	0	0	api.fda.gov
b-ONE Ortho Corp.	Fairfield, NJ, United States	Specification developer	6	October 6, 2022	0	0	api.fda.gov
Arthrex, Inc.	Naples, FL, United States	Specification developer	5	November 12, 2015	1	0	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer	5	November 16, 2017	0	0	api.fda.gov
Arthrex Manufacturing Inc.	Pendleton, SC, United States	Contract manufacturer, Contract sterilizer, Manufacturer	4	November 19, 2014	0	0	api.fda.gov
CPM Medical Consultants, LLC.	Farmers Branch, TX, United States	Complaint file establishment, Specification developer	3	August 16, 2021	0	0	api.fda.gov
Osteoremedies, LLC	Memphis, TN, United States	Specification developer	3	October 2, 2024	0	0	api.fda.gov
Biopro, Inc.	Port Huron, MI, United States	Manufacturer	2	September 21, 1993	0	0	api.fda.gov
Mako Surgical Corp.	Weston, FL, United States	Specification developer	2	December 4, 2024	0	0	api.fda.gov
Novosource, LLC	Morgantown, WV, United States	Complaint file establishment, Manufacturer, Specification developer	2	September 16, 2013	0	0	api.fda.gov
Zimmer Manufacturing B.V.	Mercedita, PR, United States	Manufacturer	2	March 29, 2018	4	0	api.fda.gov
Kyocera Medical Technologies, Inc.	Redlands, CA, United States	Complaint file establishment, Specification developer	1	June 20, 2019	0	0	api.fda.gov
Surgtech, Inc.	Westlake, OH, United States	Manufacturer, Specification developer	1	August 1, 2019	0	0	api.fda.gov
Unik Orthopedics, Inc	San Jose, CA, United States	Manufacturer	1	June 27, 2024	0	0	api.fda.gov
Advanced Concept Innovations LLC	Lakeland, FL, United States	Contract manufacturer	0		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 - Philadelphia, LLC Dba Jade Precision Medical Components	Huntingdon Valley, 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
ARCH Medical Solutions - Warsaw	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH-MedTorque	Kenosha, WI, United States	Contract manufacturer	0		0	0	api.fda.gov
Advanced Machine, Inc.	Winchester, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Arthrex, Inc.	Ave Maria, FL, United States	Contract manufacturer, Contract sterilizer	0		0	0	api.fda.gov
Autocam Medical	Murfreesboro, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Avalign Delivery Systems Division	Greenwood, IN, 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
Branch Medical Group	Eagleville, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Branch Medical Group	Limerick, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Blue Belt Technologies, Inc.	Pittsburgh, PA, United States	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+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
Culver Tool & Engineering	Plymouth, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Complexus Medical	Mishawaka, IN, 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
Eptam Plastics, Ltd	Northfield, NH, 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
Freudenberg Medical, LLC	Carpinteria, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
Gauthier Biomedical, Inc.	Grafton, WI, United States	Contract manufacturer	0		0	0	api.fda.gov
Hammill MFG. Co.	Maumee, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
Incipio Devices	Huntington, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Instru-Med Technologies	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Isomedix Operations Inc.	Spartanburg, SC, United States	Contract sterilizer, Manufacturer for export	0		0	0	api.fda.gov
Jarvis Surgical Inc.	Westfield, MA, 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	Molalla, OR, United States	Contract manufacturer	0		0	0	api.fda.gov
Lowell,inc.	Brooklyn Park, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Lincotek Medical	Bartlett, TN, 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
Mach Medical	Columbia City, IN, 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
Maitland Engineering	South Bend, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Marson Medical, Inc.	Paramus, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
Medical Modeling - A 3D Systems Company	Littleton, CO, United States	Contract manufacturer	0		0	0	api.fda.gov
Medtech LLC	Millington, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
Moebius Precision Corp	Lansing, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Mack Proto	Gardner, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
Mendell	Lakeville, MN, United States	Contract 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
Micron Solutions, Inc.	Fitchburg, MA, 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
Onkos Surgical, Inc.	Parsippany, NJ, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Onyx Medical LLC	Memphis, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Optimotion Implants, LLC	Orlando, FL, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Orchid Orthopedic Solutions Lansing	Holt, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Orchid Orthopedic Solutions Oregon, Inc.	Oregon City, OR, 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
Oberg Medical - Finishing Solutions	Wallingford, CT, United States	Contract manufacturer	0		0	0	api.fda.gov
Oberg Medical - XL Division	Chicago, IL, United States	Contract manufacturer	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
Perryman Company	Houston, PA, 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
Pro-Tech Design & MFG., Inc.	Santa Fe Springs, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
PRO-TECH Design & Mfg, Inc.	Arlington, TX, United States	Contract manufacturer	0		0	0	api.fda.gov
Paragon Medical - Dayton	Dayton, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
Paragon Medical Inc.	Smithfield, UT, 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
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Restoration Medical Polymers	Columbia City, 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
RMS Co.	Minneapolis, MN, 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.	Mansfield, MA, United States	Manufacturer	0		0	0	api.fda.gov
Steripack Usa (limited) LLC	Lakeland, FL, United States	Contract 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
Sites Medical, LLC	Columbia City, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Summit Orthopedic Technologies Inc.	Naples, FL, United States	Contract manufacturer	0		0	0	api.fda.gov
T & L Sharpening, Inc.	Indiana Beach, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Trigon Incorporated	Mc Murray, PA, 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
Tecomet Inc.	Wilmington, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
Trilliant Surgical LLC	Houston, TX, United States	Contract manufacturer	0		0	0	api.fda.gov
VIPER TECHNOLOGIES, LLC. (d.b.a Avalign Thortex)	Parkrose, OR, United States	Contract manufacturer	0		0	0	api.fda.gov
Viant AS&O Holdings, LLC	Indianapolis, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Viant AS&O Holdings, LLC	Brimfield, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
Viant Medical, LLC	Fort Wayne, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
restor3d, inc.	Durham, NC, United States	Complaint file establishment, Manufacturer	0		0	0	api.fda.gov
rms Surgical	Anoka, MN, United States	Contract manufacturer	0		0	0	api.fda.gov

Updated November 3, 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.