510(k) K232414

Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post by Total Joint Othopedics, Inc. — Product Code JWH

K232414 is an FDA 510(k) premarket notification submitted by Total Joint Othopedics, Inc. for the device "Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post". The FDA issued a decision of Substantially Equivalent on Sep 8, 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.