# K202912: ARIX Ankle Distal Tibia System

- Pathway: 510(k) (Special)
- Applicant: Jeil Medical Corporation
- Decided: Oct 29, 2020 after 30 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 K962616 (1996). 74 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170313: ARIX Ankle Distal Tibia System, Jeil Medical Corporation (2017) Summary page 5.
- K172008: ARIX Humerus System, Jeil Medical Corporation (2017) Summary page 5.
- K001945: Synthes (Usa) Medial Distal Tibia Plates, Synthes (Usa) (2000) Summary page 5.

## Most influential descendants
- K232115: TDM Large Bone Plate and Screw System (2024), 0 descendants of its own

## Indications for use
The ARIX Ankle Distal Tibia System is intended for fixation of complex intra- and extraarticular fractures and osteotomies of the distal tibia including distal tibia fractures in combination with diaphyseal fracture.

Source page: https://510kreport.com/device/K202912
Methodology: https://510kreport.com/methodology