# K131566: Arix Hand System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Nov 4, 2013 after 158 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: 6 generations back to K962616 (1996). 17 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062498: Profyle System, Howmedica Osteonics Corp. (2006) Summary page 1.

## Most influential descendants
- K212348: ALPHALOK™ Plating System (2022), 3 descendants of its own
- K221558: ALPHALOK Plating System (2022), 2 descendants of its own
- K192417: ARIX Cannulated Screw System (2019), 1 descendant of its own
- K161746: ARIX Hand System (2016), 1 descendant of its own
- K233816: REDEMPTION Charcot Plating System (2024), 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/K131566
Methodology: https://510kreport.com/methodology