# K160191: Align Anterior Ankle Fusion Plate

- Pathway: 510(k) (Traditional)
- Applicant: Extremity Medical, LLC
- Decided: Mar 25, 2016 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: 13 generations back to K954385 (1996). 157 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 163 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081934: Extremity Medical Compression Screw, Extremity Medical, LLC (2008) Summary page 4.
- K133691: Extrimilock Ankle Plating System, Osteomed LP (2014) Summary page 4.
- K132591: Maxlock Extreme System, Orthohelix Surgical Designs, Inc. (2013) Summary page 4.
- K121425: Ortholoc 3DI Ankle Fusion Plating System, Wrightmedicaltechnologyinc (2012) Summary page 4.

## Most influential descendants
- K181067: AlignX Ankle Fusion System (2018), 4 descendants of its own
- 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 Align Anterior Ankle Fusion Plate is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints.

Source page: https://510kreport.com/device/K160191
Methodology: https://510kreport.com/methodology