510(k) K143543

Prelude PF Patellae by Biomet, Inc. — Product Code KRR

K143543 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "Prelude PF Patellae". The FDA issued a decision of Substantially Equivalent on January 30, 2015. 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. Biomet, Inc. has at least 10 other 510(k) clearances on record.