# K122185: U-Motion II Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corp.
- Decided: Feb 22, 2013 after 214 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: 10 generations back to K955033 (1996). 189 ancestors in all.
7 later devices descend from it; 6 cite it directly.
0 of 196 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050262: U2 Acetabular Component, United Orthopedic Corp. (2005) Summary page 1.
- K121777: U2 Acetabular Cup, Plasma Spray, United Orthopedic Corp. (2012) Summary page 1.
- K111546: U2 Hip System, United Orthopedic Corp. (2011) Summary page 1.
- K103497: Ceramic Femoral Head, United Orthopedic Corp. (2011) Summary page 1.
- K112463: United 36MM Ceramic Femoral Head, Delta, United Orthopedic Corporation (2011) Summary page 1.
- K093472: Trinity Acetabular System, Corin USA (2010) Summary page 1.
- K103518: Trinity Acetabular System, Corin USA (2011) Summary page 1.
- K061253: Reflection 3 Acetabular System, Smith & Nephew, Inc. (2006) Summary page 1.
- K070756: Smith and Nephew Reflection 3 Acetabular System, Smith & Nephew, Inc. (2007) Summary page 1.
- K092386: R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners, Smith & Nephew, Inc. (2009) Summary page 1.
- K083762: Biolox Delta Ceramic Femoral Heads, Smith & Nephew, Inc. (2009) Summary page 1.
- K100412: Biolox Delta Ceramic Femoral Heads, Smith & Nephew, Inc. (2010) Summary page 1.
- K093846: Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Zimmer, Inc. (2010) Summary page 2.
- K101229: Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular System and Trilogy Integrated Taper, Zimmer, Inc. (2010) Summary page 5.
- K103662: Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly Crosslinked Polyethylene Elevated LI, Zimmer, Inc. (2011) Summary page 2.
- K091508: Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System, Zimmer, Inc. (2009) Summary page 2.

## Most influential descendants
- K163441: Locking Cage, Full XPE Cup (2017), 3 descendants of its own
- K132455: U-Motion II PS+ Cup (2013), 3 descendants of its own
- K172833: E-XPE Acetabular Components and U-Motion II Acetabular Cup (2018), 2 descendants of its own
- K170089: U-Motion II Acetabular System— Additional sizes (2017), 2 descendants of its own
- K221149: U-Motion II Acetabular System-Extension line (2023), 1 descendant 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. The device is intended for cementless use.

Source page: https://510kreport.com/device/K122185
Methodology: https://510kreport.com/methodology