# K131311: Arix Foot System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Sep 5, 2013 after 121 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: 5 generations back to K953806 (1996). 26 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 36 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 2.
- K023360: Leforte System Bone Plate, Jeil Medical Corporation (2002) Summary page 2.
- K023365: Leforte System Bone Screw, Jeil Medical Corporation (2003) Summary page 2.
- K112457: Leforte System Bone Plate & Screw, Arkin Consulting Group (2012) Summary page 2.

## Most influential descendants
- K161864: ARIX Foot System (2016), 5 descendants of its own
- K172260: Omni Foot Plating System (2017), 4 descendants of its own
- K170780: ARIX Foot System (2.3/2.8) (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

## 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. tag screw techniques. joint fusions, corrective osteotomies. and the treatment of fractures.

Source page: https://510kreport.com/device/K131311
Methodology: https://510kreport.com/methodology