# K221920: ARIX Small Fragment System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Aug 24, 2022 after 54 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: 1 generation back to K063049 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 4.

## Indications for use
The ARIX Small Fragment System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments. Examples include, but are not limited to, the hand, wrist, foot, and ankle.

Source page: https://510kreport.com/device/K221920
Methodology: https://510kreport.com/methodology