KWN
5 FDA 510(k) clearances · Product code
78 daysmedian time to decision
160 days90th percentile
5clearances measured
FDA profile
- Official device name
- Prosthesis, Wrist, Carpal Lunate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3750
- Medical specialty
- Orthopedic
- Flags
- Implant
- Adverse events (MAUDE)
- 1994: 1 · 1998: 2 · 2007: 2
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 |
|---|---|---|
| Wrist Hemiarthroplasty System (K141920) | Arthrosurface, Inc. | 2014-12-23 |
| ASCENSION PYROCARBON LUNATE (K080997) | Ascension Orthopedics, Inc. | 2008-06-17 |
| MAESTRO CARPAL HEMIARTHROPLASTY (K050028) | Biomet Manufacturing, Inc. | 2005-03-25 |
| SWANSON TITANIUM CARPAL LUNATE IMPLANT (K864491) | Dow Corning Wright | 1987-04-15 |
| AMC R METACARPAL COMPONENT (K790793) | Howmedica Corp. | 1979-06-22 |
Track KWN automatically
Every clearance here is in the API, with alerts when new ones post.