Data / Medical devices / Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer / United States
FDA-registered makers of Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer in the United States: 53 establishments
53 establishments in the United States are registered with the FDA to make Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer (product code HRY). 15 have a 510(k) clearance or PMA approval on file and 8 have a recall event. FDA data exported November 3, 2026.
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- Device
- Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- Product code
- HRY
- Country
- United States
Makers of Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 11 | March 28, 2014 | 0 | 7 | 0 | api.fda.gov |
| Depuy Orthopaedics, Inc. | Warsaw, IN, United States | Manufacturer, Specification developer | 6 | August 17, 2007 | 0 | 2 | 0 | api.fda.gov |
| Depuy Orthopaedics, Inc. | Raynham, MA, United States | Manufacturer | 4 | April 16, 2020 | 0 | 0 | 0 | api.fda.gov |
| Howmedica Osteonics Corp | Mahwah, NJ, United States | Contract manufacturer, Contract sterilizer, Manufacturer, Specification developer | 3 | March 20, 2015 | 0 | 1 | 0 | api.fda.gov |
| Encore Medical, L.P. | Austin, TX, United States | Manufacturer | 2 | August 23, 2002 | 0 | 1 | 0 | api.fda.gov |
| Microport Orthopedics Inc. | Arlington, TN, United States | Manufacturer | 2 | May 8, 1996 | 0 | 2 | 0 | api.fda.gov |
| Zimmer, Inc. | Warsaw, IN, United States | Contract manufacturer, Manufacturer | 2 | March 5, 2004 | 0 | 1 | 0 | api.fda.gov |
| Biopro, Inc. | Port Huron, MI, United States | Manufacturer | 1 | November 6, 1989 | 0 | 0 | 0 | api.fda.gov |
| Exactech, Inc. | Gainesville, FL, United States | Manufacturer | 1 | October 1, 2004 | 0 | 1 | 0 | api.fda.gov |
| Exactech Sarasota | Sarasota, FL, United States | Manufacturer | 1 | October 1, 2004 | 0 | 0 | 0 | api.fda.gov |
| Mako Surgical Corp. | Weston, FL, United States | Specification developer | 1 | March 20, 2015 | 0 | 0 | 0 | api.fda.gov |
| Maxx Orthopedics Inc. | Norristown, PA, United States | Manufacturer, Specification developer | 1 | February 19, 2008 | 0 | 0 | 0 | api.fda.gov |
| Materialise USA, LLC. | Plymouth, MI, United States | Manufacturer | 1 | May 16, 2011 | 0 | 1 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 1 | July 26, 1976 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 1 | July 26, 1976 | 0 | 0 | 0 | api.fda.gov |
| Advanced Concept Innovations LLC | Lakeland, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Almark Tool & Manufacturing Company, Inc. | Garwood, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aps Materials, Inc. | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Lexington, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Kentwood, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Advanced Machine, Inc. | Winchester, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Murfreesboro, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blue Belt Technologies, Inc. | Pittsburgh, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Engineered Medical Systems, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instru-Med Technologies | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ken-Mar Machine MFG Corp | Paterson, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lincotek Medical, LLC | Molalla, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lincotek Medical LLC | Vandalia, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mach Medical | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marson Medical, Inc. | Paramus, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC. | Fall River, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Metal Craft Machine & Engineering, Inc. | Elk River, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oberg Medical Products Company | Sarver, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Orthopedic Solutions Oregon, Inc. | Oregon City, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Orthopedics-Chelsea | Chelsea, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Orthopedic Solutions Alabama LLC | Arab, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical, Inc. | Pierceton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Perryman Company | Houston, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical Inc. | Smithfield, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phillips Precision Inc | Elmwood Park, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Restoration Medical Polymers | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Riverside Machine & Engineering, Inc. | Eau Claire, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SCT, Inc. | Franklin Lakes, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew Inc. | Mansfield, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc | Claypool, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turnco Tool & Instrument, Inc. | Georgetown, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turner Medical Inc. | Athens, AL, United States | Contract manufacturer | 0 | 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.