# K161746: ARIX Hand System

- Pathway: 510(k) (Special)
- Applicant: Jeil Medical Corporation
- Decided: Sep 21, 2016 after 89 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 K962616 (1996). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131566: Arix Hand System, Jeil Medical Corporation (2013) Summary page 4.

## Most influential descendants
- K191972: ARIX Wrist System (2019), 0 descendants of its own

## Indications for use
The ARIX Hand System is intended for use in internal fixation of the bones of hand and wrist. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.

Source page: https://510kreport.com/device/K161746
Methodology: https://510kreport.com/methodology