Data / Medical devices / Prosthesis, Hip, Hemi-, Femoral, Metal Ball / United States
FDA-registered makers of Prosthesis, Hip, Hemi-, Femoral, Metal Ball in the United States: 20 establishments
20 establishments in the United States are registered with the FDA to make Prosthesis, Hip, Hemi-, Femoral, Metal Ball (product code LZY). 5 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 3, 2026.
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- Device
- Prosthesis, Hip, Hemi-, Femoral, Metal Ball
- Product code
- LZY
- Country
- United States
Makers of Prosthesis, Hip, Hemi-, Femoral, Metal Ball in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 2 | July 19, 2023 | 0 | 1 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 2 | July 19, 2023 | 0 | 0 | 0 | api.fda.gov |
| Depuy Orthopaedics, Inc. | Warsaw, IN, United States | Manufacturer, Specification developer | 1 | October 3, 1990 | 0 | 1 | 0 | api.fda.gov |
| E. Bac Si Imports LLC | Ellensburg, WA, United States | Complaint file establishment, Specification developer | 1 | July 19, 1989 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 1 | February 15, 1990 | 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 | |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biopro, Inc. | Port Huron, MI, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Depuy Orthopaedics, Inc. | Raynham, MA, 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 | |
| Onyx Medical LLC | Memphis, TN, 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 | |
| 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 | |
| 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 |
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.