Cleared Traditional

METAFIX FEMORAL HIP STEM SIZE 1

K121439 · Corin USA · Orthopedic

Sep 2012

Decision

122d

Days

Class 2

Risk

About This 510(k) Submission

K121439 is an FDA 510(k) clearance for the METAFIX FEMORAL HIP STEM SIZE 1, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on September 14, 2012, 122 days after receiving the submission on May 15, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K121439 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 15, 2012
Decision Date	September 14, 2012
Days to Decision	122 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353