# K170313: ARIX Ankle Distal Tibia System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Jul 27, 2017 after 176 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: 7 generations back to K000684 (2000). 36 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013248: Synthes LCP Distal Tibia Plates, Synthes (Usa) (2001) Summary page 5.
- K163044: ORTHOLOC® 3Di Ankle Fracture Plating System, Wrightmedicaltechnologyinc (2017) Summary page 5.
- K103705: Low Profile Screws, Arthrex, Inc. (2011) Summary page 5.

## Most influential descendants
- 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

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

Source page: https://510kreport.com/device/K170313
Methodology: https://510kreport.com/methodology