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Global Modular Replacement System (Gmrs)

by Howmedica Osteonics Corp.

510(k) K023087

Global Modular Replacement System (Gmrs) is a Class II device made by Howmedica Osteonics Corp., cleared under FDA 510(k) K023087 on 16 Dec 2002, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K023087; other models may be affected

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK023087 Date16 Dec 2002ClearedStatusActive

Official records

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-2732-2024 FDA Class II initiated 5 Aug 2024 on shared 510(k) K023087

    A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.

    • Terminated Z-2624-2010 FDA Unclassified (pre-2012) initiated 5 May 2005

    Mislabeled package: Package labeled as GMRS Extension Piece 60 mm, lot ZYCOC1 actually contains a GMRS Extension Piece 70 mm extension piece.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

3 dated events

  1. Cleared FDA 510(k) K023087
  2. Recall initiated FDA recalls Z-2624-2010
  3. Recall initiated FDA recalls Z-2732-2024

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  • Withdrawn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
KRO
Device class
Class II
Regulation
21 CFR Part 888.3510
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

1 more clearance cites this device.

Source: 510k-lineage (choiben314), CC BY 4.0

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