# K151468: ARIX Wrist System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Jan 14, 2016 after 227 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). 21 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103332: Aptus Ulna Plates, Medartis AG (2011) Summary page 5.
- K142906: APTUS Wrist 2.5 System, Medartis AG (2015). Cleared while this submission was under review Summary page 5.

## Most influential descendants
- K172008: ARIX Humerus System (2017), 3 descendants of its own
- K170705: ARIX Wrist System (2017), 2 descendants of its own
- K202912: ARIX Ankle Distal Tibia System (2020), 1 descendant of its own
- K180972: ARIX Clavicle System (2018), 1 descendant of its own
- K232115: TDM Large Bone Plate and Screw System (2024), 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/K151468
Methodology: https://510kreport.com/methodology