# K141735: Arthrex Ankle Fusion Plating System

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Aug 15, 2014 after 49 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K000684 (2000). 75 ancestors in all.
38 later devices descend from it; 12 cite it directly.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123241: Arthrex Fracture Plates, Arthrex, Inc. (2013) Summary page 5.

## Most influential descendants
- K201132: Arthrex Compression Screws (2020), 11 descendants of its own
- K171808: TDM Plate and Screw System (2018), 6 descendants of its own
- K182361: Arthrex Compression FT Screws (2018), 4 descendants of its own
- K181067: AlignX Ankle Fusion System (2018), 4 descendants of its own
- K182148: SILVERBACK Gorilla Plating System (2018), 3 descendants of its own

## Recalls of this device
- Oct 1, 2019 · Class II · Z-1510-2020: Screws provided in the device package are 6 mm longer than intended.

## Indications for use
The Arthrex Ankle Fusion Plating System is intended to be used 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, and fibula. The Arthrex Low Profile Screws (2.5mm 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, Osteotomy Plates, and Ankle Fusion Plating System.

Source page: https://510kreport.com/device/K141735
Methodology: https://510kreport.com/methodology