510(k) K053299

REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT by Biomet Manufacturing, Inc. — Product Code HRY

K053299 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing, Inc. for the device "REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT". The FDA issued a decision of Substantially Equivalent on January 5, 2006. The device falls under product code HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3530. Biomet Manufacturing, Inc. has at least 10 other 510(k) clearances on record.