# K171285: ARIX Diaphysis System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Jul 24, 2017 after 84 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: 9 generations back to K962616 (1996). 31 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 5.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 5.
- K112560: Aptus (R) Distal Humerus System, Medartis AG (2011) Summary page 5.
- K082300: Anatomic Locking Plating System, DePuy Orthopaedics, Inc. (2009) Summary page 5.

## Most influential descendants
- K172008: ARIX Humerus System (2017), 3 descendants of its own
- K202912: ARIX Ankle Distal Tibia System (2020), 1 descendant of its own
- K180972: ARIX Clavicle System (2018), 1 descendant of its own
- K232115: TDM Large Bone Plate and Screw System (2024), 0 descendants of its own
- K230938: ARIX Humerus System (2023), 0 descendants of its own

## Indications for use
The ARIX Diaphysis System is intended for intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K171285
Methodology: https://510kreport.com/methodology