# K253713: Arthrex Variable Angle (VA) Proximal Tibia Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jan 21, 2026 after 58 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: 14 generations back to K962616 (1996). 256 ancestors in all.
No later device cites it as a predicate yet.
0 of 257 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210837: Smith & Nephew Plates and Screws, Smith & Nephew, Inc. (2021) Summary page 5.
- K123241: Arthrex Fracture Plates, Arthrex, Inc. (2013) Summary page 5.
- K222244: Arthrex 3.5 mm Locking Compression Plates, Arthrex, Inc. (2022) Summary page 5.

## Indications for use
The Arthrex Lateral Proximal Tibia Plate is indicated for adult patients, as well as patients with osteopenic bone. It is indicated for fixation of fractures of the tibia. The Arthrex Medial Proximal Tibia Plate is indicated for adult patients, as well as patients with osteopenic bone. It is indicated for fixation of fractures of the tibia. The Arthrex Posteromedial Proximal Tibia Plates are intended to be used for internal bone fixation for bone fractures in the tibia.

Source page: https://510kreport.com/device/K253713
Methodology: https://510kreport.com/methodology