# K180972: ARIX Clavicle System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Oct 3, 2018 after 173 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K792022 (1979). 97 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130116: Superior Lateral Variax Clavicle Plate, Stryker Trauma AG (2013) Summary page 5.
- K112111: Acu-Sinch Repair System and Acumed Suture Anchor, Acumed, LLC (2011) Summary page 5.
- K170705: ARIX Wrist System, Jeil Medical Corporation (2017) Summary page 5.
- K171285: ARIX Diaphysis System, Jeil Medical Corporation (2017) Summary page 5.

## Most influential descendants
- K191972: ARIX Wrist System (2019), 0 descendants of its own

## Indications for use
The ARIX Clavicle System is indicated for the fixation of single, segmental and comminuted fractures, osteotomies, mal-unions, and non-unions of the clavicle.

Source page: https://510kreport.com/device/K180972
Methodology: https://510kreport.com/methodology