Submission Details
| 510(k) Number | K230952 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 04, 2023 |
| Decision Date | June 02, 2023 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
K230952 is an FDA 510(k) clearance for the Triathlon? Total Knee System - Triathlon? Pro Posterior Stabilized (PS) Femoral Component, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on June 2, 2023, 59 days after receiving the submission on April 4, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.
| 510(k) Number | K230952 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 04, 2023 |
| Decision Date | June 02, 2023 |
| Days to Decision | 59 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 |