# K161864: ARIX Foot System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Aug 2, 2016 after 26 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 K953806 (1996). 27 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063875: Stryker Foot Plating System, Howmedica Osteonics Corp. (2007) Summary page 5.
- K131311: Arix Foot System, Jeil Medical Corporation (2013) Summary page 5.

## Most influential descendants
- K172260: Omni Foot Plating System (2017), 4 descendants of its own
- K180808: Omni Foot Plating System (2018), 3 descendants of its own
- K212297: Omni Foot and Ankle Plating System (2021), 1 descendant of its own
- K221362: Omni Foot and Ankle Plating System (2022), 0 descendants of its own
- K192592: Axis Plating System (2019), 0 descendants of its own

## Indications for use
The ARIX Foot System is intended for use in internal fixation, reconstruction, or arthrodesis of small bones including the fore, mid- and hind foot and ankle. 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/K161864
Methodology: https://510kreport.com/methodology