510(k) K935452

P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT by Johnson & Johnson Orthopaedics, Inc. — Product Code LZO

K935452 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Orthopaedics, Inc. for the device "P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT". The FDA issued a decision of Substantially Equivalent on October 6, 1994. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Johnson & Johnson Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.