# K242247: ARIX Femur Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Apr 22, 2025 after 265 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: 9 generations back to K970097 (1997). 42 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 44 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.

## Most influential descendants
- K252826: ARIX Femur Nail System (2025), 0 descendants of its own

## 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/K242247
Methodology: https://510kreport.com/methodology