# K222267: Arthrex 2.4 mm Volar Distal Radius Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Oct 3, 2022 after 67 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: 10 generations back to K000684 (2000). 60 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131474: Arthrex Distal Radius Plate System, Arthrex, Inc. (2013) Summary page 5.
- K150456: Arthrex Plates, Screws, and Staples, Arthrex, Inc. (2015) Summary page 5.

## Most influential descendants
- K243368: Montblanc Plate System (2025), 0 descendants of its own

## Indications for use
The Arthrex 2.4 mm Volar Distal Radius Plate System is intended for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius and distal ulna. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and malunions. This system can be used for palmar, dorsal or orthogonal application. The Arthrex Low Profile Screws (2.4 mm, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile, Small Fragment Plates, Distal Extremity Plates, and Distal Radius Plates.

Source page: https://510kreport.com/device/K222267
Methodology: https://510kreport.com/methodology