510(k) K180159

Klassic® Knee System by Total Joint Orthopedics, Inc. — Product Code JWH

K180159 is an FDA 510(k) premarket notification submitted by Total Joint Orthopedics, Inc. for the device "Klassic® Knee System". The FDA issued a decision of Substantially Equivalent on March 9, 2018. 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.