# K981238: Bipolar Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Whiteside Biomechanics, Inc.
- Decided: Aug 21, 1998 after 140 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
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K050269: U1 Hip System - Bipolar (2005), 6 descendants of its own
- K101670: United U2 Bipolar Implant (2010), 5 descendants of its own
- K152439: U2 Bipolar Implant and 22mm Femoral Head (2016), 3 descendants of its own
- K162957: U2 Femoral Head (2017), 1 descendant of its own
- K221675: United U2 femoral head, 22mm delta ceramic head (2022), 0 descendants of its own

## Indications for use
1. Noninflammatory degenerative joint disease including osteoarthritis. 2. Avascular necrosis. 3. Correction of functional deformity. 4. Revision procedures where other treatments or devices have failed. 5. Treatment of femoral neck and trochanteric fractures of the proximal femur with head involvement and non-union of femoral neck fractures.

Source page: https://510kreport.com/device/K981238
Methodology: https://510kreport.com/methodology