# K110245: United Utf Stem

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corporation
- Decided: Aug 4, 2011 after 189 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to P960047 (1997). 26 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052792: Anthology Hip Stem, Smith & Nephew, Inc. (2005) Summary page 1.
- K921301: Taperloc Femoral Stem and Universal Acetabular Com, Biomet, Inc. (1994) Summary page 1.
- K043537: Taperloc 12/14 Taper Femoral Components, Biomet, Inc. (2005) Summary page 1.

## Most influential descendants
- K123550: Utf Stem, Reduced (2013), 4 descendants of its own
- K132207: Utf Stem-Reduced, Additional Sizes (2013), 3 descendants of its own
- K163193: UTF Stem, reduced, #0, #00 (2017), 2 descendants of its own
- K172251: UTS Stem (2017), 1 descendant of its own
- K163585: Responsive Orthopedics Total Hip Arthroplasty System (2017), 1 descendant of its own

## Recalls of this device
- Feb 20, 2013 · Class II · Z-1385-2013: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to

## 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: non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia; inflammatory degenerative joint disease such as rheumatoid arthritis; correction of functional deformity; treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; revision procedures where other treatments or devices have failed. UTF Stem is designed for cementless use.

Source page: https://510kreport.com/device/K110245
Methodology: https://510kreport.com/methodology