510(k) K172326

Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System by Stryker Orthopaedics — Product Code JWH

K172326 is an FDA 510(k) premarket notification submitted by Stryker Orthopaedics for the device "Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System". The FDA issued a decision of Substantially Equivalent on October 30, 2017. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Stryker Orthopaedics has at least 10 other 510(k) clearances on record.