510(k) K032151

DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS by Depuy, Inc. — Product Code JWH

K032151 is an FDA 510(k) premarket notification submitted by Depuy, Inc. for the device "DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS". The FDA issued a decision of Substantially Equivalent on September 26, 2003. 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. Depuy, Inc. has at least 10 other 510(k) clearances on record.