510(k) K140942

KLASSIC KNEE TIBIAL STEM EXTENSION by Total Joint Orthopedics, Inc. — Product Code JWH

K140942 is an FDA 510(k) premarket notification submitted by Total Joint Orthopedics, Inc. for the device "KLASSIC KNEE TIBIAL STEM EXTENSION". The FDA issued a decision of Substantially Equivalent on May 16, 2014. 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.