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Pivot Bipolar 133-2846

by Ortho Development Corp.

Pivot Bipolar 133-2846 is a Class II device made by Ortho Development Corp., cleared under FDA 510(k) K050966 on 7 Jul 2005 and listed in FDA GUDID since 31 Aug 2015 (UDI-DI 00822409015306), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K050966

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00822409015306 UDI-DI Date31 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK050966 Date7 Jul 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K050966 decided 7 Jul 2005 Active
  • FDA GUDID UDI-DI 00822409015306 listed 31 Aug 2015 Listed

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.

Timeline

4 dated events

  1. Cleared FDA 510(k) K050966
  2. Recall initiated FDA recalls Z-0086-2010
  3. Recall initiated FDA recalls Z-2253-2014
  4. Listed FDA GUDID 00822409015306

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pivot Bipolar
Generic name
Bipolar femoral head outer component, hemiarthroplasty
Model / reference
133-2846
Primary DI / UDI-DI
00822409015306
510(k) Number
FDA product code
KWY
GMDN term
Bipolar femoral head outer component, hemiarthroplasty
Device class
Class II
Regulation number
888.3390
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 46 Millimeter
Lumen/Inner Diameter — 28 Millimeter

Related devices

Category: Bipolar femoral head outer component, hemiarthroplasty

Cleared under the same submission (K050966)

and 8 more cleared under K050966

Similar devices in this category

Other devices filed under Bipolar femoral head outer component, hemiarthroplasty.

Other devices from Ortho Development Corp.

See all devices from Ortho Development Corp. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)