510(k) K230078

TRAX® CR Total Knee System by Amplitude — Product Code JWH

K230078 is an FDA 510(k) premarket notification submitted by Amplitude for the device "TRAX® CR Total Knee System". The FDA issued a decision of Substantially Equivalent on November 3, 2023. 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. Amplitude has at least 1 other 510(k) clearance on record.