# K191972: ARIX Wrist System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Nov 12, 2019 after 111 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: 12 generations back to K792022 (1979). 102 ancestors in all.
No later device cites it as a predicate yet.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170705: ARIX Wrist System, Jeil Medical Corporation (2017) Summary page 5.
- K151468: ARIX Wrist System, Jeil Medical Corporation (2016) Summary page 5.
- K161746: ARIX Hand System, Jeil Medical Corporation (2016) Summary page 5.
- K050932: Distal Volar Radius Anatomical Plate System, Hand Innovations, Inc. (2005) Summary page 5.
- K092247: Synthes Locking Hand Plates, Synthes (Usa) (2009) Summary page 5.
- K062498: Profyle System, Howmedica Osteonics Corp. (2006) Summary page 5.
- K180972: ARIX Clavicle System, Jeil Medical Corporation (2018) Summary page 5.

## 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/K191972
Methodology: https://510kreport.com/methodology