510(k) K172326 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System
| Applicant | Stryker Orthopaedics, Mahwah NJ, US |
| Decision | Substantially Equivalent, Oct 30, 2017 |
| Received | Aug 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172326
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2021 | Howmedica Osteonics Corp. Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.
Catalog N Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.