# K243466: Conformity Stem Extension Line, #0

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corporation
- Decided: Jan 6, 2025 after 59 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- 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). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183312: Conformity Stem, United Orthopedic Corporation (2019) Summary page 5.
- K242249: Conformity Stem Extension Line, United Orthopedic Corporation (2024) Summary page 5.

## 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 dysplasia. 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 replacement or total hip replacement. 5. Certain cases of ankylosis. Conformity stem is for cementless use only.

Source page: https://510kreport.com/device/K243466
Methodology: https://510kreport.com/methodology