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Magna-Fx and Mini Magna-Fx Cannulated Screw Fixation System

by Zimmer, Inc.

510(k) K142442

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 NumberK142442 Date3 Oct 2014ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-1679-2016 FDA Class II initiated 4 May 2016

    A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

  • 2 recalls, same reason

    • Terminated Z-1142-2016 FDA Class II initiated 11 Jan 2016
    • Terminated Z-1144-2016 FDA Class II initiated 11 Jan 2016

    As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

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  • Withdrawn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
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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