510(k) K060127

HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS by Arthrosurface, Inc. — Product Code KRR

K060127 is an FDA 510(k) premarket notification submitted by Arthrosurface, Inc. for the device "HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS". The FDA issued a decision of Substantially Equivalent on March 16, 2006. 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. Arthrosurface, Inc. has at least 10 other 510(k) clearances on record.