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Secur-Fit Ha and Secur-Fit Plus Hip Stems

by Howmedica Osteonics Corp.

510(k) K041170

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK041170 Date9 Nov 2004ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0894-2009 FDA Unclassified (pre-2012) initiated 13 Nov 2008
    • Terminated Z-0893-2009 FDA Unclassified (pre-2012) initiated 13 Nov 2008

    Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.

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  • Withdrawn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
LZO
Device Class
Class II
Regulation
21 CFR Part 888.3353
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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