# K050966: Pivot Bipolar Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Jul 7, 2005 after 80 days
- Product code: KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3390
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K091967: Medacta Bipolar Head (2010), 9 descendants of its own
- K082705: Biopro Bipolar Head, Models 18130-18152 (2008), 7 descendants of its own
- K133370: Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem, Evolve Distal Centralizer, Evolve CE (2014), 5 descendants of its own
- K100761: Biopro Polar Head (2010), 4 descendants of its own
- K241461: Mpact Constrained Liner (2025), 1 descendant of its own

## Recalls of this device
- Jul 11, 2014 · Class II · Z-2253-2014: 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 int
- Apr 29, 2009 · Not classified · Z-0086-2010: A Pivot BiPolar Head, the femoral head in a hip prosthesis, might not move freely after assembly due a stacking up of manufacturing tolerances.

## Indications for use
The device is intended for use in hip arthroplasty in cemented and uncemented primary or revision applications whose indications include: 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis or post traumatic arthritis. 2. Proximal femoral neck fractures or dislocation. 3. Idiopathic avascular necrosis of the femoral head. 4. Non-union of proximal femoral neck fractures. 5. Treatment of fractures that are unmanageable using other forms of therapy.

Source page: https://510kreport.com/device/K050966
Methodology: https://510kreport.com/methodology