# K152439: U2 Bipolar Implant and 22mm Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corporation
- Decided: Apr 7, 2016 after 224 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: 7 generations back to K941847 (1994). 64 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101670: United U2 Bipolar Implant, United Orthopedic Corp. (2010) Summary page 4.
- K050269: U1 Hip System - Bipolar, United Orthopedic Corp. (2005) Summary page 4.
- K994078: U1 Hip System, United Orthopedic Corp. (2000) Summary page 4.
- K800207: Uhr UNIVERSAL6HIP Replacement, Osteonics Corp. (1980) Summary page 4.
- K964769: Versys Hip System--Fiber Metal Taper Hip Prosthesis, Zimmer, Inc. (1997) Summary page 4.
- K013211: Modification to: Acumatch L-Series Bipolar Endoprosthesis, Exactech, Inc. (2001) Summary page 4.
- K060707: Aesculap Bipolar Acetabular Cup, Aesculap, Inc. (2006) Summary page 4.

## Most influential descendants
- 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 intended for use in combination with UNITED Femoral System for cemented or cementless hip replacement. This device may be used for the following conditions: 1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli and painful hip dysplasia. 2. Inflammatory degenerative joint disease such as rheumatoid arthritis. 3. Correction of function deformity. 4. Revision procedures where other treatments or devices have failed. 5. 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/K152439
Methodology: https://510kreport.com/methodology