# K221675: United U2 femoral head, 22mm delta ceramic head

- Pathway: 510(k) (Special)
- Applicant: United Orthopedic Corporation
- Decided: Nov 4, 2022 after 148 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: 12 generations back to K810258 (1981). 273 ancestors in all.
No later device cites it as a predicate yet.
0 of 273 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162957: U2 Femoral Head, United Orthopedic Corporation (2017) Summary page 4.
- K112463: United 36MM Ceramic Femoral Head, Delta, United Orthopedic Corporation (2011) Summary page 4.
- K103497: Ceramic Femoral Head, United Orthopedic Corp. (2011) Summary page 4.
- K180929: Klassic HD® Hip System, Total Joint Orthopedics, Inc. (2018) Summary page 4.
- K122185: U-Motion II Acetabular System, United Orthopedic Corp. (2013) Summary page 4.

## 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. In the USA: United U2 femoral head, 22mm delta ceramic head is only indicated for use with the hemi (bipolar) implant.

Source page: https://510kreport.com/device/K221675
Methodology: https://510kreport.com/methodology