# K253357: b-ONE® Bipolar Head

- Pathway: 510(k) (Traditional)
- Applicant: B-One Ortho, Corp.
- Decided: Apr 13, 2026 after 195 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K812672 (1981). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K812672: Self-Centering Hip, Depuy, Inc. (1981) Summary page 5.

## Indications for use
The Bipolar Head is intended to be used for hemi-hip arthroplasty with evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem and is indicated in the following conditions: 1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation. 2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. 3. Avascular necrosis of the femoral head 4. Non-union of femoral neck fractures. 5. Certain high subcapital and femoral neck fractures in the elderly. 6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement. 7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.

Source page: https://510kreport.com/device/K253357
Methodology: https://510kreport.com/methodology