KYK
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3500
- Medical specialty
- Orthopedic
- Flags
- Implant
- Adverse events (MAUDE)
- 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 |
|---|---|---|
| MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM (K880826) | Johnson & Johnson Professionals, Inc. | 1988-03-14 |
| MODIFIED TOWNLEY UNICONDYLAR KNEE (K871118) | Depuy, Inc. | 1987-04-06 |
| SYNATOMIC VARIABLE FIT TIBIAL PLATEAU (K851341) | Depuy, Inc. | 1985-07-15 |
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Every clearance here is in the API, with alerts when new ones post.