# K172008: ARIX Humerus System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Dec 1, 2017 after 151 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: 10 generations back to K962616 (1996). 38 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011815: Synthes LCP Proximal Humerus Plates, Synthes (Usa) (2001) Summary page 4.
- K171285: ARIX Diaphysis System, Jeil Medical Corporation (2017). Cleared while this submission was under review Summary page 5.
- K151468: ARIX Wrist System, Jeil Medical Corporation (2016) Summary page 5.
- K152158: ARIX Ankle System, Jeil Medical Corporation (2015) Summary page 5.

## Most influential descendants
- K202912: ARIX Ankle Distal Tibia System (2020), 1 descendant of its own
- K232115: TDM Large Bone Plate and Screw System (2024), 0 descendants of its own
- K230938: ARIX Humerus System (2023), 0 descendants of its own

## Indications for use
ARIX Humerus System is indicated for fractures, fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K172008
Methodology: https://510kreport.com/methodology