Cleared Traditional

METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS

K113271 · Biomet Manufacturing, Inc. · Orthopedic

May 2012

Decision

196d

Days

Class 3

Risk

About This 510(k) Submission

K113271 is an FDA 510(k) clearance for the METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS, a Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (Class III — Premarket Approval, product code KWA), submitted by Biomet Manufacturing, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 18, 2012, 196 days after receiving the submission on November 4, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3330.

Submission Details

510(k) Number	K113271 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 04, 2011
Decision Date	May 18, 2012
Days to Decision	196 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWA — Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Device Class	Class III — Premarket Approval
CFR Regulation	21 CFR 888.3330