# K163193: UTF Stem, reduced, #0, #00

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corporation
- Decided: Jun 8, 2017 after 205 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: 7 generations back to P960047 (1997). 29 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123550: Utf Stem, Reduced, United Orthopedic Corporation (2013) Summary page 4.
- K132207: Utf Stem-Reduced, Additional Sizes, United Orthopedic Corporation (2013) Summary page 4.
- K110245: United Utf Stem, United Orthopedic Corporation (2011) Summary page 4.

## Most influential descendants
- K172251: UTS Stem (2017), 1 descendant of its own
- K242315: Resolve Modular Revision Hip Stem (2025), 0 descendants of its own

## Indications for use
This device is indicated for use in total hip replacement or bipolar hip replacement undergoing primary and revision surgery for the following conditions: 1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia. 2. Inflammatory degenerative joint disease such as rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision procedures where other treatments or devices have failed. This device is designed for cementless use.

Source page: https://510kreport.com/device/K163193
Methodology: https://510kreport.com/methodology