# K132876: Arix Hand Locking System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Dec 18, 2013 after 96 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 K962616 (1996). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062498: Profyle System, Howmedica Osteonics Corp. (2006) 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 4.

## Indications for use
The ARIX Hand Locking System is intended for use in internal fixation of the bones of hand and wrist. 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/K132876
Methodology: https://510kreport.com/methodology