# K231887: ARIX Ankle Distal Tibia System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Dec 14, 2023 after 170 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: 15 generations back to K954385 (1996). 218 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 220 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181067: AlignX Ankle Fusion System, Extremity Medical, LLC (2018) Summary page 5.
- K141735: Arthrex Ankle Fusion Plating System, Arthrex, Inc. (2014) Summary page 5.

## Most influential descendants
- K252246: Leforte MMF System (2026), 0 descendants of its own

## Indications for use
The ARIX Ankle Distal Tibia System(Ankle fusion) is indicated for facilitating arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints.

Source page: https://510kreport.com/device/K231887
Methodology: https://510kreport.com/methodology