K211512 is an FDA 510(k) clearance for the VISIONAIRE UK Patient Matched Cutting Guides. 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. (Cordova, US). The FDA issued a Cleared decision on September 16, 2021, 125 days after receiving the submission on May 14, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3520.
| 510(k) Number | K211512 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2021 |
| Decision Date | September 16, 2021 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| 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 |