# K050269: U1 Hip System - Bipolar

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corp.
- Decided: Aug 29, 2005 after 206 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 K981238 (1998). 1 ancestor in all.
6 later devices descend from it; 3 cite 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)
- K981238: Bipolar Femoral Head, Whiteside Biomechanics, Inc. (1998) Summary page 1.

## Most influential descendants
- 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
- K173455: SurgTech Bipolar Head System (2018), 0 descendants of its own

## Indications for use
This device is indicated in partial hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: * Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; * Inflammatory degenerative joint disease such as rheumatoid arthritis; * Correction of function deformity; * Revision procedures where other treatments or devices have failed; and * Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Source page: https://510kreport.com/device/K050269
Methodology: https://510kreport.com/methodology