Data / Medical devices / Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented / United States
FDA-registered makers of Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented in the United States: 82 establishments
82 establishments in the United States are registered with the FDA to make Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented (product code KWY). 22 have a 510(k) clearance or PMA approval on file and 9 have a recall event. FDA data exported November 3, 2026.
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- Device
- Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Product code
- KWY
- Country
- United States
Makers of Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented 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 | 5 | October 31, 2008 | 0 | 4 | 0 | api.fda.gov |
| Ortho Development Corp. | Draper, UT, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | 4 | July 7, 2005 | 0 | 0 | 0 | api.fda.gov |
| Zimmer, Inc. | Warsaw, IN, United States | Contract manufacturer, Manufacturer, Specification developer | 4 | August 27, 2004 | 0 | 5 | 0 | api.fda.gov |
| Depuy Orthopaedics, Inc. | Warsaw, IN, United States | Manufacturer, Specification developer | 3 | September 18, 1995 | 0 | 0 | 0 | api.fda.gov |
| Exactech, Inc. | Gainesville, FL, United States | Manufacturer | 3 | December 5, 2001 | 0 | 1 | 0 | api.fda.gov |
| UOC USA Inc. | Irvine, CA, United States | Manufacturer, Manufacturer for export | 3 | April 7, 2016 | 0 | 0 | 0 | api.fda.gov |
| Kyocera Medical Technologies, Inc. | Redlands, CA, United States | Complaint file establishment, Specification developer | 2 | April 17, 2020 | 0 | 0 | 0 | api.fda.gov |
| Maxx Orthopedics Inc. | Norristown, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | August 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| Microport Orthopedics Inc. | Arlington, TN, United States | Manufacturer, Manufacturer for export | 2 | September 29, 2006 | 0 | 0 | 0 | api.fda.gov |
| Shalby Advanced Technologies, Inc. | El Dorado Hills, CA, United States | Manufacturer | 2 | November 5, 2012 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 2 | January 23, 2003 | 0 | 2 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 2 | January 23, 2003 | 0 | 0 | 0 | api.fda.gov |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 1 | July 8, 2008 | 0 | 0 | 0 | api.fda.gov |
| B-One Ortho, Corp. | Cedar Knolls, NJ, United States | Specification developer | 1 | April 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| Biopro, Inc. | Port Huron, MI, United States | Contract manufacturer, Manufacturer | 1 | December 3, 2010 | 0 | 1 | 0 | api.fda.gov |
| Encore Medical, L.P. | Austin, TX, United States | Manufacturer | 1 | August 9, 1995 | 0 | 1 | 0 | api.fda.gov |
| Surgtech, Inc. | Westlake, OH, United States | Manufacturer, Specification developer | 1 | June 14, 2018 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 1 | January 23, 2003 | 0 | 0 | 0 | api.fda.gov |
| Theken Companies, LLC | Akron, OH, United States | Complaint file establishment, Specification developer | 1 | September 17, 2019 | 0 | 0 | 0 | api.fda.gov |
| Total Joint Orthopedics, Inc. | Salt Lake City, UT, United States | Complaint file establishment, Specification developer | 1 | January 28, 2015 | 0 | 1 | 0 | api.fda.gov |
| Zimmer Manufacturing B.V. | Mercedita, PR, United States | Manufacturer | 1 | January 30, 1984 | 0 | 1 | 0 | api.fda.gov |
| b-ONE Ortho Corp. | Fairfield, NJ, United States | Specification developer | 1 | April 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| Abbott Laboratories | Irving, TX, United States | Specification developer | 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 | |
| ARCH Medical Solutions - Seabrook | Seabrook, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Plymouth, MA, 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 | |
| Avalign Instruments & Implants | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C&A Tool Engineering, Inc. Auburn Plant | Auburn, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C&W Swiss, Inc. | Clayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C+a Tool Engineering, Inc. | Churubusco, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Centex Machining, Inc. | Round Rock, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cep Bio-Coat, LLC | Farmington Hills, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Orthopaedics, Inc. | Raynham, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Donson Machine Company | Alsip, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dot America, Inc. | Columbia City, IN, United States | Contract 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 | |
| Five Star Manufacturing, Inc. | New Bedford, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Globus Medical, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Howmedica Osteonics Corp | Mahwah, NJ, United States | Manufacturer, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Himed, LLC | Old Bethpage, NY, 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 | |
| Isomedix Operations Inc. | Spartanburg, SC, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| LH Medical Corporation | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mack Molding Company | Arlington, VT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maitland Engineering | South Bend, 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 | |
| Medtech LLC | Millington, TN, 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 | |
| Materialise USA, LLC. | Plymouth, MI, United States | 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 | |
| NGInstruments, Inc dba Avalign Cutting Instruments | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Norwood Medical LLC | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onkos Surgical, Inc. | Parsippany, NJ, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onyx Medical LLC | Memphis, TN, 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 Unique | Bridgeport, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osteoremedies, LLC | Memphis, TN, United States | Specification developer | 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 | |
| Precision Edge Surgical Products Company | Sault Sainte Marie, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Tech Design & MFG., Inc. | Santa Fe Springs, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical Inc. | Castleton, IN, 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 | |
| Polymer Corporation | Middletown, CT, 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 | |
| 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 | |
| Single Source Medical LLC | Churubusco, IN, 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. | Memphis, TN, 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 | |
| Symmetry Medical, Inc. - Manchester | Manchester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trelleborg Sealing Solutions Litchfield | Litchfield, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| rms Surgical | Anoka, MN, 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.