510(k) K914439

P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL by Johnson & Johnson Orthopaedics, Inc. — Product Code HSX

K914439 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Orthopaedics, Inc. for the device "P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL". The FDA issued a decision of Substantially Equivalent on October 23, 1991. The device falls under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3520. Johnson & Johnson Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.