Data / Medical devices / Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing (NJL): 22 FDA-registered makers in 4 countries
22 establishments in 4 countries are registered with the FDA to make Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing (product code NJL, Class 3). 8 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 15 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NJL
- Device class
- 3
- Medical specialty
- Unknown
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 15 |
| Ireland | 3 |
| United Kingdom | 2 |
| China | 2 |
Makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Depuy (ireland) | CO. CORK Munster, Ireland | Manufacturer, Repackager or relabeler | 0 | 1 | 0 | 0 | api.fda.gov | |
| Depuy Intl., Ltd. | Leeds, United Kingdom | Manufacturer, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Depuy Orthopaedics, Inc. | Warsaw, IN, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 1 | 8 | 0 | api.fda.gov | |
| Depuy Orthopaedics, Inc. | Raynham, MA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Depuy Synthes (suzhou) Medical Devices Co., Ltd. | SUZHOU Jiangsu, China | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Depuy Ireland UC | Co. Cork Munster, Ireland | Manufacturer, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Zimmer, Inc. | Warsaw, IN, United States | Manufacturer, Manufacturer for export | 0 | 1 | 5 | 0 | api.fda.gov | |
| Zimmer Orthopedic Mfg Ltd | Shannon Clare, Ireland | Manufacturer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Automatics Tooling Company Ltd | Salfords Surrey, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Exactech, Inc. | Gainesville, FL, United States | Manufacturer for export | 0 | 0 | 1 | 0 | api.fda.gov | |
| Isomedix Operations Inc. | Northborough, MA, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations, Inc. | Libertyville, IL, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mack Molding Company | Arlington, VT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Modeling - A 3D Systems Company | Littleton, CO, 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 | |
| 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 Device (Changzhou) Co., Ltd. | Changzhou Jiangsu, China | Contract 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 | |
| Sterigenics US, LLC | Lewis Center, OH, United States | Contract sterilizer, Manufacturer for export | 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 |
Updated November 2, 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.