510(k) K190402

Triathlon Total Knee System-Additional Components by Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) — Product Code JWH

K190402 is an FDA 510(k) premarket notification submitted by Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) for the device "Triathlon Total Knee System-Additional Components". The FDA issued a decision of Substantially Equivalent on Aug 22, 2019. 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.