510(k) K190280

Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly by Total Joint Orthopedics, Inc. — Product Code JWH

K190280 is an FDA 510(k) premarket notification submitted by Total Joint Orthopedics, Inc. for the device "Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly". The FDA issued a decision of Substantially Equivalent on March 15, 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.