# K152158: ARIX Ankle System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Sep 28, 2015 after 56 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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: 1 generation back to K081284 (2008). 1 ancestor in all.
6 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081284: Variax Distal Fibula Plate, Howmedica Osteonics Corp. (2008) Summary page 5.

## Most influential descendants
- K172008: ARIX Humerus System (2017), 3 descendants of its own
- K202912: ARIX Ankle Distal Tibia System (2020), 1 descendant of its own
- K232115: TDM Large Bone Plate and Screw System (2024), 0 descendants of its own
- K230938: ARIX Humerus System (2023), 0 descendants of its own
- K193616: ARIX Ankle System (2020), 0 descendants of its own

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

Source page: https://510kreport.com/device/K152158
Methodology: https://510kreport.com/methodology