# K162957: U2 Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corporation
- Decided: Jul 17, 2017 after 266 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K941847 (1994). 93 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994078: U1 Hip System, United Orthopedic Corp. (2000) Summary page 4.
- K022520: U2 Acetabular Cup, United Orthopedic Corp. (2003) Summary page 4.
- K111546: U2 Hip System, United Orthopedic Corp. (2011) Summary page 4.
- K122504: Femoral Heads, 2.5 and 7.5 MM Neck Length, United Orthopedic Corporation (2012) Summary page 4.
- K152439: U2 Bipolar Implant and 22mm Femoral Head, United Orthopedic Corporation (2016) Summary page 4.

## Most influential descendants
- K221675: United U2 femoral head, 22mm delta ceramic head (2022), 0 descendants of its own

## Indications for use
The device is indicated for use in hip arthroplasty in patients with the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery. This device is a single use implant and intended for cementless use only except cemented stem which is designed for cemented use only.

Source page: https://510kreport.com/device/K162957
Methodology: https://510kreport.com/methodology