Data / Medical devices / Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented / United States
FDA-registered makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented in the United States: 110 establishments
110 establishments in the United States are registered with the FDA to make Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (product code LZO). 21 have a 510(k) clearance or PMA approval on file and 10 have a recall event. FDA data exported November 3, 2026.
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- Device
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Product code
- LZO
- Country
- United States
Makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Howmedica Osteonics Corp | Mahwah, NJ, United States | Manufacturer, Specification developer | 24 | April 24, 2024 | 0 | 11 | 0 | api.fda.gov |
| Microport Orthopedics Inc. | Arlington, TN, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Reprocessor | 22 | May 15, 2025 | 0 | 2 | 0 | api.fda.gov |
| Zimmer, Inc. | Warsaw, IN, United States | Contract manufacturer, Manufacturer, Specification developer | 19 | June 16, 2026 | 0 | 10 | 0 | api.fda.gov |
| Exactech, Inc. | Gainesville, FL, United States | Manufacturer | 18 | May 19, 2023 | 0 | 7 | 0 | api.fda.gov |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer, Specification developer | 16 | December 8, 2020 | 0 | 8 | 0 | api.fda.gov |
| Depuy Orthopaedics, Inc. | Warsaw, IN, United States | Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer | 16 | January 6, 2023 | 0 | 1 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 12 | March 28, 2025 | 0 | 1 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 12 | March 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| UOC USA Inc. | Irvine, CA, United States | Manufacturer, Manufacturer for export | 10 | January 6, 2025 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 8 | July 19, 2021 | 0 | 0 | 0 | api.fda.gov |
| Ortho Development Corp. | Draper, UT, United States | Complaint file establishment, Manufacturer, Specification developer | 6 | September 21, 2011 | 0 | 0 | 0 | api.fda.gov |
| Shalby Advanced Technologies, Inc. | El Dorado Hills, CA, United States | Manufacturer | 6 | April 10, 2003 | 0 | 0 | 0 | api.fda.gov |
| Encore Medical, L.P. | Austin, TX, United States | Manufacturer, Specification developer | 5 | February 7, 2025 | 0 | 1 | 0 | api.fda.gov |
| Total Joint Orthopedics, Inc. | Salt Lake City, UT, United States | Complaint file establishment, Specification developer | 5 | September 23, 2022 | 0 | 0 | 0 | api.fda.gov |
| B-One Ortho, Corp. | Cedar Knolls, NJ, United States | Manufacturer | 4 | November 15, 2024 | 0 | 0 | 0 | api.fda.gov |
| b-ONE Ortho Corp. | Fairfield, NJ, United States | Specification developer | 4 | November 15, 2024 | 0 | 0 | 0 | api.fda.gov |
| Biopro, Inc. | Port Huron, MI, United States | Contract manufacturer, Manufacturer | 3 | January 18, 1996 | 0 | 1 | 0 | api.fda.gov |
| Maxx Orthopedics Inc. | Norristown, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | January 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 2 | April 11, 2011 | 0 | 1 | 0 | api.fda.gov |
| Depuy Orthopaedics, Inc. | Raynham, MA, United States | Manufacturer | 1 | March 1, 2013 | 0 | 0 | 0 | api.fda.gov |
| Xerxes Arthropedix | Naples, FL, United States | Specification developer | 1 | June 15, 2023 | 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 | Murfreesboro, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Additive / Slice Manufacturing Studios | Akron, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Delivery Systems Division | Greenwood, IN, 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 | |
| B & G MFG. Co. | Hatfield, PA, 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 | |
| CPM Medical Consultants, LLC. | Farmers Branch, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Culver Tool & Engineering | Plymouth, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ConforMIS, Inc. | Wilmington, MA, United States | Manufacturer, Specification developer | 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 | |
| Ferry Machine Corporation | Oakland, NJ, 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 | |
| Flex-Cell Precision, Inc. | Lancaster, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferry Machine Corporation | Little Ferry, NJ, 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 | |
| Hammill MFG. Co. | Maumee, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harwood Design, Inc. | Bristol, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Himed, LLC | Old Bethpage, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Incipio Devices | Huntington, IN, 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 | |
| Kyocera Medical Technologies, Inc. | Redlands, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LH Medical Corporation | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lincotek Medical | Bartlett, TN, 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 | |
| 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 | |
| Micropulse Inc | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mid South Precision | Murfreesboro, 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 | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mendell | Lakeville, MN, 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 | |
| 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 | |
| Novosource, LLC | Morgantown, WV, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oberg Medical Products Company | Sarver, PA, 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 | |
| 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 | |
| PRO-TECH Design & Mfg, Inc. | Arlington, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical - Dayton | Dayton, OH, 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 | |
| ProMade PoC Center for Complex Orthopedic Solutions at HSS | Manhattan, NY, 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 | |
| Rayco Steel Process, Inc. | Warsaw, 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 | |
| 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 | |
| Surgtech, Inc. | Westlake, OH, United States | Manufacturer, Specification developer | 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 Manufacturing Inc. | Lansing, MI, 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 | |
| T & L Sharpening, Inc. | Indiana Beach, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Theken Companies, LLC | Akron, OH, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trigon Incorporated | Mc Murray, PA, United States | Contract 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 | |
| VIPER TECHNOLOGIES, LLC. (d.b.a Avalign Thortex) | Parkrose, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vaupell Midwest Molding and Tooling | Constantine, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant AS&O Holdings, LLC | Brimfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Windsor Beach Technologies, Inc. | Fairview, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zimmer Manufacturing B.V. | Mercedita, PR, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zimmer Trabecular Metal Technology, Inc. | Parsippany, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| restor3d, inc. | Durham, NC, United States | Complaint file establishment, 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.