510(k) K910563

P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL by Johnson & Johnson Orthopaedics, Inc. — Product Code JWH

K910563 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Orthopaedics, Inc. for the device "P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL". The FDA issued a decision of Substantially Equivalent on May 23, 1991. 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. Johnson & Johnson Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.