510(k) K924340

P.F.C. MOD TOTAL KNEE/CONDYL 3 FEM COMP TIB INSERT by Johnson & Johnson Orthopaedics, Inc. — Product Code JWH

K924340 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Orthopaedics, Inc. for the device "P.F.C. MOD TOTAL KNEE/CONDYL 3 FEM COMP TIB INSERT". The FDA issued a decision of Substantially Equivalent on January 25, 1994. 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.