# K181806: ARIX Sternal System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Nov 20, 2018 after 137 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: 12 generations back to K761228 (1976). 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)
- K110574: Biomet Microfixation Sternalock Blu Sternal Closure System, Biomet Microfixation, Inc. (2011) Summary page 5.
- K111908: Biomet Microfixation Sternal Closure System, Biomet Microfixation, Inc. (2011) Summary page 5.
- K121302: Biomet Microfixation Sternal Closure System, Biomet Microfixation (2012) Summary page 5.
- K161896: Biomet Microfixation Sternal Closure System, Biomet Microfixation (2016) Summary page 5.

## Indications for use
The ARIX Sternal System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion.

Source page: https://510kreport.com/device/K181806
Methodology: https://510kreport.com/methodology