510(k) K962557

GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT by Smith & Nephew Richards, Inc. — Product Code JWH

K962557 is an FDA 510(k) premarket notification submitted by Smith & Nephew Richards, Inc. for the device "GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT". The FDA issued a decision of SN on December 5, 1996. 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. Smith & Nephew Richards, Inc. has at least 10 other 510(k) clearances on record.