Cleared Traditional

OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)

K133940 · Biomet UK, Ltd. · Orthopedic

Mar 2014

Decision

95d

Days

Class 2

Risk

About This 510(k) Submission

K133940 is an FDA 510(k) clearance for the OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS), a Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HRY), submitted by Biomet UK, Ltd. (Warsaw, US). The FDA issued a Cleared decision on March 28, 2014, 95 days after receiving the submission on December 23, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3530.

Submission Details

510(k) Number	K133940 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2013
Decision Date	March 28, 2014
Days to Decision	95 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