Cleared Special

MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM

K032641 · Portland Orthopaedics Pty. , Ltd. · Orthopedic

Jan 2004

Decision

146d

Days

Class 2

Risk

About This 510(k) Submission

K032641 is an FDA 510(k) clearance for the MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM, a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II — Special Controls, product code MEH), submitted by Portland Orthopaedics Pty. , Ltd. (Matraville Nsw, AU). The FDA issued a Cleared decision on January 20, 2004, 146 days after receiving the submission on August 27, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K032641 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 27, 2003
Decision Date	January 20, 2004
Days to Decision	146 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MEH — Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353