# K143749: Arthrex Distal Radius System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Apr 3, 2015 after 93 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 K000684 (2000). 50 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082300: Anatomic Locking Plating System, DePuy Orthopaedics, Inc. (2009) Summary page 4.
- K081546: Small Bone Locking Plating System, DePuy Orthopaedics, Inc. (2008) Summary page 4.
- K131474: Arthrex Distal Radius Plate System, Arthrex, Inc. (2013) Summary page 4.
- K040907: Arthrex Small Fragment Plates and Screws, Arthrex, Inc. (2004) Summary page 4.

## Most influential descendants
- K254162: KLS Martin Ixos System (2026), 0 descendants of its own
- K220244: DVR® Crosslock Wrist Spanning Plate (131849181) (2022), 0 descendants of its own

## Indications for use
The Arthrex Distal Radius System is intended for fixation of fractures, fusions, osteotomies and non-unions of the radius, ulna, olecranon, metacarpal, metatarsal, and malleolus.

Source page: https://510kreport.com/device/K143749
Methodology: https://510kreport.com/methodology