K926334 is an FDA 510(k) clearance for the AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER. 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 18, 1994, 671 days after receiving the submission on December 16, 1992.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3560.
| 510(k) Number | K926334 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | December 16, 1992 |
| Decision Date | October 18, 1994 |
| Days to Decision | 671 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3560 |