Cleared Special

K032641 - MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM

K032641 is an FDA 510(k) clearance for MODIFICATION TO: THE MARGRON HIP REPLAC..., manufactured by Portland Orthopaedics Pty. , Ltd.. The device is a Class 2 Orthopedic device with product code MEH cleared through the Special 510(k) pathway after a 146-day FDA review.

K032641 · Portland Orthopaedics Pty. , Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
146d
Days
Class 2
Risk

K032641 is an FDA 510(k) clearance for the MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Portland Orthopaedics Pty. , Ltd. (Matraville Nsw, AU). The FDA issued a Cleared decision on January 20, 2004 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K032641

510(k) Number K032641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 122d · This submission: 146d
Pathway characteristics
Modification to existing cleared device.

MEH Device Classification - Class 2, Special Controls

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 159
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K032641.
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K032641 · MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM
Download PDF FDA Summary Portland Orthopaedics…