Cleared Traditional

OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM

K122277 · Biomet Manufacturing Corp · Orthopedic

Oct 2012

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K122277 is an FDA 510(k) clearance for the OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM, a Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HRY), submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on October 22, 2012, 84 days after receiving the submission on July 30, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3530.

Submission Details

510(k) Number	K122277 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 30, 2012
Decision Date	October 22, 2012
Days to Decision	84 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