510(k) K021908

PROVEN MODULAR POSTERIOR STABILIZED FEMORAL by Stelkast Company — Product Code JWH

K021908 is an FDA 510(k) premarket notification submitted by Stelkast Company for the device "PROVEN MODULAR POSTERIOR STABILIZED FEMORAL". The FDA issued a decision of Substantially Equivalent on July 9, 2002. 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.