510(k) K230537

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

K230537 is an FDA 510(k) premarket notification submitted by Total Joint Othopedics, Inc. for the device "Klassic Knee Revision System". The FDA issued a decision of Substantially Equivalent on May 19, 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. Total Joint Othopedics, Inc. has at least 7 other 510(k) clearances on record.