510(k) K984158

P.F.C. MODULAR PLUS OFFSET TIBIAL TRAY by Depuy, Inc. — Product Code JWH

K984158 is an FDA 510(k) premarket notification submitted by Depuy, Inc. for the device "P.F.C. MODULAR PLUS OFFSET TIBIAL TRAY". The FDA issued a decision of Substantially Equivalent on January 28, 1999. 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.