510(k) K243991

Klassic Knee System - Revision Tibial Baseplate by Total Joint Othopedics, Inc. — Product Code JWH

K243991 is an FDA 510(k) premarket notification submitted by Total Joint Othopedics, Inc. for the device "Klassic Knee System - Revision Tibial Baseplate". The FDA issued a decision of Substantially Equivalent on Mar 24, 2025. 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. Total Joint Othopedics, Inc. has at least 7 other 510(k) clearances on record.