# K181067: AlignX Ankle Fusion System

- Pathway: 510(k) (Special)
- Applicant: Extremity Medical, LLC
- Decided: May 23, 2018 after 30 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 K954385 (1996). 217 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 222 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160191: Align Anterior Ankle Fusion Plate, Extremity Medical, LLC (2016) Summary page 4.
- K141735: Arthrex Ankle Fusion Plating System, Arthrex, Inc. (2014) Summary page 4.
- K132591: Maxlock Extreme System, Orthohelix Surgical Designs, Inc. (2013) Summary page 4.
- K133691: Extrimilock Ankle Plating System, Osteomed LP (2014) Summary page 4.

## Most influential descendants
- K231887: ARIX Ankle Distal Tibia System (2023), 1 descendant of its own
- K212297: Omni Foot and Ankle Plating System (2021), 1 descendant of its own
- K252246: Leforte MMF System (2026), 0 descendants of its own
- K221362: Omni Foot and Ankle Plating System (2022), 0 descendants of its own

## Indications for use
The AlignX Ankle Fusion System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints.

Source page: https://510kreport.com/device/K181067
Methodology: https://510kreport.com/methodology