LGE
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3530
- Medical specialty
- Orthopedic
- Flags
- Implant
- Adverse events (MAUDE)
- 2004: 3 · 2010: 7
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| KINEMATIC II ROTATING HINGE KNEE (K992346) | Howmedica Osteonics Corp. | 1999-08-12 | + Add |
| KINEMATIC ROTATING HINGE TOTAL KNEE PR. (K811630) | Howmedica Corp. | 1981-07-01 | + Add |
Track LGE automatically
Every clearance here is in the API, with alerts when new ones post.