510(k) K053514

TRIATHLON TOTAL KNEE SYSTEM by Stryker Orthopaedics — Product Code JWH

K053514 is an FDA 510(k) premarket notification submitted by Stryker Orthopaedics for the device "TRIATHLON TOTAL KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 26, 2006. 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.