# K130149: U2 Hip System, Expanded Indications for Use

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corporation
- Decided: Jun 6, 2013 after 135 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: 6 generations back to K941847 (1994). 73 ancestors in all.
No later device cites it as a predicate yet.
1 of 73 devices in its family (counting itself) has 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.
- K022520: U2 Acetabular Cup, United Orthopedic Corp. (2003) Summary page 1.
- K050262: U2 Acetabular Component, United Orthopedic Corp. (2005) Summary page 1.
- K062978: U2 Hip Stem, TI Plasma Spray, United Orthopedic Corp. (2007) Summary page 1.
- K111546: U2 Hip System, United Orthopedic Corp. (2011) Summary page 1.
- K121777: U2 Acetabular Cup, Plasma Spray, United Orthopedic Corp. (2012) Summary page 1.
- K122504: Femoral Heads, 2.5 and 7.5 MM Neck Length, United Orthopedic Corporation (2012) Summary page 1.
- K021346: Stem Hip Replacement System, Model PHA002XX, Wrightmedicaltechnologyinc (2002) Summary page 3.
- K071082: Stryker Modular Hip System, Howmedica Osteonics Corp. (2007) Summary page 3.
- K041850: Medallion Modular Hip System, Biomet Manufacturing, Inc. (2004) Summary page 3.
- K050269: U1 Hip System - Bipolar, United Orthopedic Corp. (2005) Summary page 3.
- K101670: United U2 Bipolar Implant, United Orthopedic Corp. (2010) Summary page 3.
- K023743: Smith & Nephew Global Bipolar System, Smith & Nephew, Inc. (2003) Summary page 3.
- K051569: Ringloc BI-Polar Acetabular Component, Biomet, Inc. (2005) Summary page 3.

## 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: 1. 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; Treatment of nonunion, femoral neck and trochanteric fractures 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 except cemented stem which is designed for cemented use only.

Source page: https://510kreport.com/device/K130149
Methodology: https://510kreport.com/methodology