# K062978: U2 Hip Stem, TI Plasma Spray

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corp.
- Decided: Jan 16, 2007 after 109 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 K000760 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000760: Reach Femoral Component, Biomet, Inc. (2000) Summary page 1.
- K003237: U2 Hip Stem, TI Porous Coated, United Orthopedic Corp. (2001) Summary page 1.

## Most influential descendants
- K130149: U2 Hip System, Expanded Indications for Use (2013), 0 descendants of its own

## 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: Non-inflammatory degenerative joint disease such as osteoathritis, 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. This device is a single use implant and intended for cementless use only.

Source page: https://510kreport.com/device/K062978
Methodology: https://510kreport.com/methodology