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Margron Hip Replacement System

by Portland Orthopaedics Pty., Ltd.

510(k) K992815

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

71 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK992815 Date7 Feb 2000ClearedStatusActive

Recalls

71 recalls · FDA

  • 71 recalls, same reason

    • Terminated Z-1991-2008 FDA Unclassified (pre-2012) initiated 11 Jan 2008
    • Terminated Z-1956-2008 FDA Unclassified (pre-2012) initiated 11 Jan 2008
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    • Terminated Z-1988-2008 FDA Unclassified (pre-2012) initiated 11 Jan 2008
    • Terminated Z-1996-2008 FDA Unclassified (pre-2012) initiated 11 Jan 2008
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    • Terminated Z-1954-2008 FDA Unclassified (pre-2012) initiated 11 Jan 2008

    Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
The Margron Hip Replacement System
510(k) Number
FDA Product Code
MEH
FDA applicant
Portland Orthopaedics Pty. , Ltd.
Device Class
Class II
Regulation
21 CFR Part 888.3353
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Margron Hip Replacement System is a total hip arthroplasty device designed to replace the femoral component of a severely disabled or painful hip joint. It is classified as an orthopedic implant intended for primary or revision procedures, providing structural support and restoring function to the hip joint.

This system is supplied as a sterile, single-use device and is regulated under FDA 510(k) clearance (K992815) as a Class II orthopedic product. It is intended for use in surgical settings where radiographic evidence of hip joint deterioration is present, and it is cleared for use without bone cement. Storage and handling must comply with sterile medical device protocols.

Other devices from Portland Orthopaedics Pty., Ltd.