# K050262: U2 Acetabular Component

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corp.
- Decided: Aug 15, 2005 after 192 days
- Product code: LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K994078 (2000). 2 ancestors in all.
42 later devices descend from it; 9 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994078: U1 Hip System, United Orthopedic Corp. (2000) Summary page 1.
- K003237: U2 Hip Stem, TI Porous Coated, United Orthopedic Corp. (2001) Summary page 1.

## Cited in the summary but kept off the family tree
- K013676: Trident Hemispherical Acetabular Shells, Howmedica Osteonics Corp. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K123705: Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular Shells (2013), 23 descendants of its own
- K121777: U2 Acetabular Cup, Plasma Spray (2012), 9 descendants of its own
- K182321: MobileLink Acetabular Cup System (2019), 8 descendants of its own
- K152893: Corin Optimized Positioning System (OPS) (2016), 8 descendants of its own
- K122185: U-Motion II Acetabular System (2013), 7 descendants of its own

## Indications for use
This device is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: * Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; * Inflammatory degenerative joint disease such as rheumatoid arthritis; * Correction of function deformity; * Revision procedures where other treatments or devices have failed; and * Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. The U2 Acetabular Components are designed for uncemented application and single use only.

Source page: https://510kreport.com/device/K050262
Methodology: https://510kreport.com/methodology