K992346 is an FDA 510(k) clearance for the KINEMATIC II ROTATING HINGE KNEE. This device is classified as a Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Trunnion-bearing (Class II - Special Controls, product code LGE).
Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on August 12, 1999, 30 days after receiving the submission on July 13, 1999.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3530.
| 510(k) Number | K992346 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1999 |
| Decision Date | August 12, 1999 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LGE — Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Trunnion-bearing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3530 |