# K203294: Arthrex Pilon Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Feb 3, 2021 after 86 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: 12 generations back to K000684 (2000). 78 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151732: Arthrex Fracture Plates, Arthrex, Inc. (2015) Summary page 6.
- K141735: Arthrex Ankle Fusion Plating System, Arthrex, Inc. (2014) Summary page 6.

## Most influential descendants
- K242554: Arthrex VAL and VAL KreuLock™ Compression Screw System (2024), 1 descendant of its own
- K260809: Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System (2026), 0 descendants of its own

## Indications for use
The Arthrex Pilon Fusion Plates are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, tibia, and calcaneous. The Arthrex Low Profile Screws (3.5mm 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, Humeral Fracture Plates and Osteotomy Plates.

Source page: https://510kreport.com/device/K203294
Methodology: https://510kreport.com/methodology