Data / Medical devices / Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained (JWJ): 23 FDA-registered makers in 5 countries
23 establishments in 5 countries are registered with the FDA to make Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained (product code JWJ, Class 2, 21 CFR 888.3800). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 17 510(k) clearances under this code, the latest on November 1, 2024, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- JWJ
- Device class
- 2
- Regulation
- 888.3800
- Medical specialty
- Orthopedic
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 18 |
| Switzerland | 2 |
| United Kingdom | 1 |
| Ireland | 1 |
| Germany | 1 |
Makers of Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
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 |
|---|---|---|---|---|---|---|---|---|
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 3 | May 30, 2024 | 0 | 0 | 0 | api.fda.gov |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 2 | July 29, 2008 | 0 | 0 | 0 | api.fda.gov |
| Arthrosurface, Inc. | W Bridgewater, MA, United States | Manufacturer | 1 | October 15, 2020 | 0 | 0 | 0 | api.fda.gov |
| Extremity Medical, LLC | Parsippany, NJ, United States | Specification developer | 1 | March 4, 2020 | 0 | 0 | 0 | api.fda.gov |
| Janco, Inc. | Rollinsford, NH, United States | Contract manufacturer, Repackager or relabeler | 1 | March 4, 2020 | 0 | 0 | 0 | api.fda.gov |
| Skeletal Dynamics, Inc | Miami, FL, United States | Complaint file establishment, Specification developer | 1 | July 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| STRYKER GmbH | SELZACH Solothurn, Switzerland | Manufacturer, Specification developer | 1 | December 2, 2002 | 0 | 0 | 0 | api.fda.gov |
| ARCH Medical Solutions - Warsaw | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Intl., Ltd. | Leeds, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Ireland UC | Co. Cork Munster, Ireland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instru-Med Technologies | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Precision Swiss | Santa Ana, CA, 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 | |
| Onyx Medical LLC | Memphis, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Orthopedics Switzerland GMBH | Baden-Daettwil Aargau, Switzerland | 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 | |
| Pro-Tech Design & MFG., Inc. | Santa Fe Springs, CA, 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 | |
| RMS Co. | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SMT Schilling Metalltechnik GMBH | MUHLHEIM Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 1, 2024. 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.