# K090139: Ankle Arthrodesis Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Oct 27, 2009 after 279 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: 3 generations back to K013415 (2002). 5 ancestors in all.
54 later devices descend from it; 1 cites it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061940: Synthes LCP Ankle Arthrodesis Plates, Synthes (Usa) (2006) Summary page 1.
- K060473: TTC Plate, New Deal, S.A. (2006) Summary page 1.

## Most influential descendants
- K121425: Ortholoc 3DI Ankle Fusion Plating System (2012), 53 descendants of its own
- K140397: Paralock Plating System / Tuffnek Screw (2014), 31 descendants of its own
- K163650: ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension (2017), 12 descendants of its own
- K200398: AxSOS 3 AF System and AxSOS 3 Ti System (2020), 9 descendants of its own
- K170693: Phantom Small Bone Intramedullary Nail System (2017), 9 descendants of its own

## Indications for use
The Tornier Ankle Arthrodesis Plate System is intended for arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, and fusions of small bones including the foot and ankle.

Source page: https://510kreport.com/device/K090139
Methodology: https://510kreport.com/methodology