K180612 is an FDA 510(k) clearance for the Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts. This device is classified as a Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (Class II - Special Controls, product code HSX).
Submitted by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on June 7, 2018, 91 days after receiving the submission on March 8, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3520.
| 510(k) Number | K180612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2018 |
| Decision Date | June 07, 2018 |
| Days to Decision | 91 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 |