# K233912: ARIX Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Mar 11, 2024 after 90 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K962616 (1996). 127 ancestors in all.
No later device cites it as a predicate yet.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220319: Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System, Stryker GmbH (2022) Summary page 5.

## Indications for use
The ARIX Cannulated Screw System is indicated for fracture fixation, fusions, osteotomies, nonunions, and malunions of fragments of long bones of the pelvis, the femur, the tibia, the humerus, and the foot. The system is not intended for use in the spine.

Source page: https://510kreport.com/device/K233912
Methodology: https://510kreport.com/methodology