# K131474: Arthrex Distal Radius Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jul 3, 2013 after 42 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: 8 generations back to K000684 (2000). 47 ancestors in all.
20 later devices descend from it; 4 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040022: Stryker Leibinger Universal Distal Radius System, Stryker Leibinger (2004) Summary page 1.
- K100271: Vari AX Distal Radius Line Extensions of XXL Plates, Howmedica Osteonics Corp. (2010)
- K123875: Aap Radius Set 2.5, Aap Implantate AG (2013) Summary page 1.
- K103705: Low Profile Screws, Arthrex, Inc. (2011) Summary page 1.
- K111253: Arthrex Distal Extremity Plate System, Arthrex, Inc. (2011) Summary page 1.

## Most influential descendants
- K201132: Arthrex Compression Screws (2020), 11 descendants of its own
- K150456: Arthrex Plates, Screws, and Staples (2015), 6 descendants of its own
- K143749: Arthrex Distal Radius System (2015), 2 descendants of its own
- K254215: Arthrex Beaming System (2026), 1 descendant of its own
- K250920: Arthrex Spine Compression FT Screw (2025), 1 descendant of its own

## Indications for use
The Arthrex 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 (2.0-2.4mm 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. The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. The Arthrex Low Profile Screws (2.7mm and larger, 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, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, and Osteotomy Plates. The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula.

Source page: https://510kreport.com/device/K131474
Methodology: https://510kreport.com/methodology