Cleared Traditional

REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT

K053299 · Biomet Manufacturing, Inc. · Orthopedic

Jan 2006

Decision

41d

Days

Class 2

Risk

About This 510(k) Submission

K053299 is an FDA 510(k) clearance for the REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT, a Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HRY), submitted by Biomet Manufacturing, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 5, 2006, 41 days after receiving the submission on November 25, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3530.

Submission Details

510(k) Number	K053299 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 25, 2005
Decision Date	January 05, 2006
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HRY — Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3530