510(k) K183596

Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly by Total Joint Orthopedics, Inc. — Product Code JWH

K183596 is an FDA 510(k) premarket notification submitted by Total Joint Orthopedics, Inc. for the device "Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly". The FDA issued a decision of Substantially Equivalent on March 29, 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. Total Joint Orthopedics, Inc. has at least 10 other 510(k) clearances on record.