510(k) K152169

Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts by Ortho Development Corporation — Product Code JWH

K152169 is an FDA 510(k) premarket notification submitted by Ortho Development Corporation for the device "Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts". The FDA issued a decision of Substantially Equivalent on October 27, 2015. 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. Ortho Development Corporation has at least 10 other 510(k) clearances on record.