K924698 is an FDA 510(k) clearance for the AXIOM TOTAL KNEE SYSTEM, MODULAR TIBIAL TRAY. This device is classified as a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II - Special Controls, product code JWH).
Submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 27, 1993, 405 days after receiving the submission on September 17, 1992.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3560.
| 510(k) Number | K924698 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 1992 |
| Decision Date | October 27, 1993 |
| Days to Decision | 405 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3560 |