# K201656: ARIX Elbow System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Sep 15, 2020 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: 9 generations back to K962616 (1996). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090053: Aptus 2.0 Radial Head System, Medartis AG (2009) Summary page 5.
- K103332: Aptus Ulna Plates, Medartis AG (2011) Summary page 5.
- K112560: Aptus (R) Distal Humerus System, Medartis AG (2011) Summary page 5.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 5.

## Indications for use
The ARIX Elbow System is intended for fractures and osteotomies of proximal radius, ulnar olecranon and distal humerus. The ARIX Proximal Radius Plate is intended for use in proximal radial fractures and osteotomies. The ARIX Olecranon Plate is intended for use in particular for ulna fractures and osteotomies. The ARIX Distal Humerus Plate is intended for use in distal humerus fractures, osteotomies and non-unions.

Source page: https://510kreport.com/device/K201656
Methodology: https://510kreport.com/methodology