# K170979: ARIX Ankle Fibula Hook Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Aug 17, 2017 after 136 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: 2 generations back to K081284 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152158: ARIX Ankle System, Jeil Medical Corporation (2015) Summary page 5.
- K081284: Variax Distal Fibula Plate, Howmedica Osteonics Corp. (2008) Summary page 5.

## Indications for use
The ARIX Ankle Fibula Hook Plate System is intended for use in internal fixation of the distal fibula.

Source page: https://510kreport.com/device/K170979
Methodology: https://510kreport.com/methodology