# K101670: United U2 Bipolar Implant

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corp.
- Decided: Oct 8, 2010 after 116 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K981238 (1998). 3 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050269: U1 Hip System - Bipolar, United Orthopedic Corp. (2005) Summary page 1.
- K062693: Gladiator Bipolar System, Wrightmedicaltechnologyinc (2006) Summary page 1.

## Most influential descendants
- 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
- K130149: U2 Hip System, Expanded Indications for Use (2013), 0 descendants of its own

## Recalls of this device
- Feb 20, 2013 · Class II · Z-1383-2013: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to

## Indications for use
This device is intended for use in combination with UNITED Femoral System for cemented or cementless hip replacement 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 theumatoid arthritis; correction of function deformity; revision procedures where other treatments or devices have failed; treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmaunageable using other techniques.

Source page: https://510kreport.com/device/K101670
Methodology: https://510kreport.com/methodology