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Pivot Bipolar Femoral Head

by Ortho Development Corp.

510(k) K050966

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 NumberK050966 Date7 Jul 2005ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2253-2014 FDA Class II initiated 11 Jul 2014

    Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.

    • Terminated Z-0086-2010 FDA Unclassified (pre-2012) initiated 29 Apr 2009

    A Pivot BiPolar Head, the femoral head in a hip prosthesis, might not move freely after assembly due a stacking up of manufacturing tolerances.

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  • Withdrawn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
KWY
Device class
Class II
Regulation
21 CFR Part 888.3390
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

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