510(k) K021578

NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE by Sulzer Orthopedics, Inc. — Product Code JWH

K021578 is an FDA 510(k) premarket notification submitted by Sulzer Orthopedics, Inc. for the device "NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE". The FDA issued a decision of Substantially Equivalent on August 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. Sulzer Orthopedics, Inc. has at least 10 other 510(k) clearances on record.