K201611 is an FDA 510(k) clearance for the Apex Knee System. This device is classified as a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II - Special Controls, product code JWH).
Submitted by Omnilife Science (Raynham, US). The FDA issued a Cleared decision on April 2, 2021, 291 days after receiving the submission on June 15, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3560.
| 510(k) Number | K201611 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2020 |
| Decision Date | April 02, 2021 |
| Days to Decision | 291 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 |