# K221149: U-Motion II Acetabular System-Extension line

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corporation
- Decided: Jan 5, 2023 after 260 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K955033 (1996). 221 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 222 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122185: U-Motion II Acetabular System, United Orthopedic Corp. (2013) Summary page 4.
- K132455: U-Motion II PS+ Cup, United Orthopedic Corp. (2013) Summary page 4.
- K170089: U-Motion II Acetabular System— Additional sizes, United Orthopedic Corporation (2017) Summary page 4.
- K172833: E-XPE Acetabular Components and U-Motion II Acetabular Cup, United Orthopedic Corporation (2018) Summary page 4.
- K111546: U2 Hip System, United Orthopedic Corp. (2011) Summary page 4.
- K983382: Osteonics HA Generation II Acetabular Component System, Osteonics Corp. (1998) Summary page 4.

## Most influential descendants
- K253948: Momentum Acetabular Cup System (2026), 0 descendants of its own

## Indications for use
The device is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 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. 4. Correction of functional deformity. 5. Treatment of nonunion femoral neck and trochanteric fracture of the proximal femur with head involvement that is unmanageable using other techniques. This device is a single use implant and intended for cementless use only.

Source page: https://510kreport.com/device/K221149
Methodology: https://510kreport.com/methodology