K081351 is an FDA 510(k) clearance for the MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT. This device is classified as a Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (Class II - Special Controls, product code HSX).
Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on July 24, 2008, 71 days after receiving the submission on May 14, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3520.
| 510(k) Number | K081351 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2008 |
| Decision Date | July 24, 2008 |
| Days to Decision | 71 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSX — Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3520 |