510(k) K063211

PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT by Stelkast Company — Product Code JWH

K063211 is an FDA 510(k) premarket notification submitted by Stelkast Company for the device "PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT". The FDA issued a decision of Substantially Equivalent on January 18, 2007. 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. Stelkast Company has at least 10 other 510(k) clearances on record.