# K170705: ARIX Wrist System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Sep 21, 2017 after 197 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: 8 generations back to K962616 (1996). 27 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151468: ARIX Wrist System, Jeil Medical Corporation (2016) Summary page 4.
- K092247: Synthes Locking Hand Plates, Synthes (Usa) (2009) Summary page 5.
- K102694: 2.4MM VA-LCP Dorsal Distal Radius Plates, Synthes (Usa) (2010) Summary page 5.

## Most influential descendants
- K180972: ARIX Clavicle System (2018), 1 descendant of its own
- K191972: ARIX Wrist System (2019), 0 descendants of its own

## Indications for use
The ARIX Wrist System(Radius) is intended for use in forearm fractures, osteotomies and arthrodesis. The ARIX Wrist System(Ulna) is intended for fractures and osteotomies, in particular for the ulna.

Source page: https://510kreport.com/device/K170705
Methodology: https://510kreport.com/methodology