# K190953: Arthrex Minimally Invasive Ankle Fusion Plate

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Oct 16, 2019 after 188 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: 11 generations back to K000684 (2000). 76 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141735: Arthrex Ankle Fusion Plating System, Arthrex, Inc. (2014) Summary page 4.

## Most influential descendants
- K202307: Activ Fuse (2020), 0 descendants of its own

## Indications for use
The Arthrex Minimally Invasive Ankle Fusion Plate is intended to be used for fixation of bone fractures and fusions in the foot and ankle. The Arthrex Minimally Invasive Ankle Fusion Plate is to be used with the Arthrex Low Profile Screws.

Source page: https://510kreport.com/device/K190953
Methodology: https://510kreport.com/methodology