# K252826: ARIX Femur Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Dec 10, 2025 after 96 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K953730 (1995). 116 ancestors in all.
No later device cites it as a predicate yet.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200869: Gamma3 System, Stryker Trauma GmbH (2020) Summary page 6.
- K242247: ARIX Femur Nail System, Jeil Medical Corporation (2025) Summary page 6.
- K231251: FlexWing Anterior Cervical Plate System, Jeil Medical Corporation (2024) Summary page 6.
- K202099: AOS Galileo™ Trochanteric Nail System, Advanced Orthopaedic Solutions, Inc. (2020) Summary page 6.

## Indications for use
ARIX Femur Nail System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).

Source page: https://510kreport.com/device/K252826
Methodology: https://510kreport.com/methodology