# K151316: U2 Hip Stem, Ti Porous Coated, Matrix

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corporation
- Decided: Aug 13, 2015 after 87 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: 1 generation back to K003237 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003237: U2 Hip Stem, TI Porous Coated, United Orthopedic Corp. (2001) Summary page 4.

## Indications for use
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/K151316
Methodology: https://510kreport.com/methodology