# K191056: Conformity stem, cemented

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corporation
- Decided: Jan 3, 2020 after 259 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K935452 (1994). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152530: UCP Stem, United Orthopedic Corporation (2016) Summary page 4.

## Indications for use
The device is indicated for use in hip arthroplasty in skeletally mature patients with the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dyplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacment or total hip replacement. 5. Certain cases of ankylosis. Conformity stem, cemented is for cemented use only.

Source page: https://510kreport.com/device/K191056
Methodology: https://510kreport.com/methodology