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New Jersey Femoral Stem

by Endomedics, Inc.

510(k) K842234

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 NumberK842234 Date20 Jul 1984ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-1627-2010 FDA Unclassified (pre-2012) initiated 5 Jun 2009 on shared 510(k) K842234
    • Terminated Z-1624-2010 FDA Unclassified (pre-2012) initiated 5 Jun 2009 on shared 510(k) K842234
    • Terminated Z-1625-2010 FDA Unclassified (pre-2012) initiated 5 Jun 2009 on shared 510(k) K842234

    Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.

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

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  • Withdrawn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
KWL
Device Class
Class II
Regulation
21 CFR Part 888.3360
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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