KWM
6 FDA 510(k) clearances · Product code
105 daysmedian time to decision
578 days90th percentile
6clearances measured
FDA profile
- Official device name
- Prosthesis, Wrist, Semi-Constrained
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3800
- Medical specialty
- Orthopedic
- Flags
- Implant
- Adverse events (MAUDE)
- 1996: 1 · 1998: 3 · 2003: 2 · 2004: 2 · 2006: 3 · 2008: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VOLZ TOTAL WRIST PROSTHESIS (K880156) | Biomet, Inc. | 1988-02-17 |
| M.W.P. WRIST PROSTHESIS (K872502) | Protek, Inc. | 1987-07-23 |
| LAURE WRIST IMPLANT (K803031) | Laure Prosthetics, Inc. | 1982-06-29 |
| TALEISNIK TOTAL WRIST PROSTHESIS (K800602) | Dow Corning Wright | 1980-08-27 |
| WEBER-MAYO WRIST (K801157) | Depuy, Inc. | 1980-08-04 |
| LODA WRIST PROSTHESIS (K790774) | Depuy, Inc. | 1979-08-03 |
Track KWM automatically
Every clearance here is in the API, with alerts when new ones post.