# K122504: Femoral Heads, 2.5 and 7.5 MM Neck Length

- Pathway: 510(k) (Special)
- Applicant: United Orthopedic Corporation
- Decided: Oct 10, 2012 after 55 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: 5 generations back to K861766 (1986). 28 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022520: U2 Acetabular Cup, United Orthopedic Corp. (2003) Summary page 1.
- K111546: U2 Hip System, United Orthopedic Corp. (2011) Summary page 1.

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

## Indications for use
This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: For use as a Total Hip Replacement 1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. 2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. 3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. For use as a Bipolar Hip Replacement 1. Femoral head/neck fractures or non-unions. 2. Aseptic necrosis of the femoral head. 3. Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion. Cemented stem is designed for cemented use only.

Source page: https://510kreport.com/device/K122504
Methodology: https://510kreport.com/methodology