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Modification to: the Margron Hip Replacement System

by Portland Orthopaedics Pty., Ltd.

510(k) K032641

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 · Special NumberK032641 Date20 Jan 2004ClearedStatusActive

Recalls

71 recalls · FDA

  • 71 recalls, same reason

    • Terminated Z-1991-2008 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-1987-2008 FDA Unclassified (pre-2012) initiated 11 Jan 2008
    • Terminated Z-1972-2008 FDA Unclassified (pre-2012) initiated 11 Jan 2008
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    • Terminated Z-1999-2008 FDA Unclassified (pre-2012) initiated 11 Jan 2008
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    • Terminated Z-1970-2008 FDA Unclassified (pre-2012) initiated 11 Jan 2008
    • Terminated Z-1995-2008 FDA Unclassified (pre-2012) initiated 11 Jan 2008
    • Terminated Z-1969-2008 FDA Unclassified (pre-2012) initiated 11 Jan 2008
    • Terminated Z-1976-2008 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  • Withdrawn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)

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

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