# K111546: U2 Hip System

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corp.
- Decided: Jul 1, 2011 after 28 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K861766 (1986). 27 ancestors in all.
13 later devices descend from it; 7 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070756: Smith and Nephew Reflection 3 Acetabular System, Smith & Nephew, Inc. (2007) Summary page 1.
- K022520: U2 Acetabular Cup, United Orthopedic Corp. (2003) Summary page 1.
- K994078: U1 Hip System, United Orthopedic Corp. (2000) Summary page 1.
- K993352: Crossfire System 12 Acetabular Inserts, Howmedica Osteonics Corp. (1999) Summary page 1.
- K061066: Synergy Hip System, Smith & Nephew, Inc. (2006) Summary page 1.
- K990369: Synergy Cemented Hip Stem, Smith & Nephew, Inc. (1999) Summary page 1.
- K001733: Allen Medullary Cement Plugs, Zimmer Poly Plug Intramedullary System, Model 8011 Series & 1109 & 8109 Series, Zimmer, Inc. (2000) Summary page 1.

## Most influential descendants
- K122185: U-Motion II Acetabular System (2013), 7 descendants of its own
- K163441: Locking Cage, Full XPE Cup (2017), 3 descendants of its own
- K132455: U-Motion II PS+ Cup (2013), 3 descendants of its own
- K122504: Femoral Heads, 2.5 and 7.5 MM Neck Length (2012), 3 descendants of its own
- K172833: E-XPE Acetabular Components and U-Motion II Acetabular Cup (2018), 2 descendants of its own

## Recalls of this device
- Feb 20, 2013 · Class II · Z-1382-2013: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to

## 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 factures 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/K111546
Methodology: https://510kreport.com/methodology