510(k) K051086

SMITH & NEPHEW PATELLO-FEMORAL IMPLANT by Smith & Nephew, Inc. — Product Code KRR

K051086 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "SMITH & NEPHEW PATELLO-FEMORAL IMPLANT". The FDA issued a decision of Substantially Equivalent on May 31, 2005. The device falls under product code KRR (Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3540. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.