KMC
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Prosthesis, Hip, Semi-Constrained, Composite/Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3340
- Medical specialty
- Orthopedic
- Flags
- Implant
- Adverse events (MAUDE)
- 1992: 1
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 |
|---|---|---|
| ENHANCED MODULAR AUSTIN MOORE HIP (K936044) | Zimmer, Inc. | 1994-04-26 |
| APR REVISION HIP PROSTHESIS, FEMORAL COMPONENT (K853524) | Intermedics Orthopedics | 1985-11-22 |
| MALLORY/HEAD TOTAL HIP SYSTEM (K853259) | Biomet, Inc. | 1985-11-01 |
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Every clearance here is in the API, with alerts when new ones post.