# K100176: Ascension Ankle Fusion Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedics, Inc.
- Decided: Jun 16, 2010 after 146 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: 5 generations back to K000684 (2000). 21 ancestors in all.
56 later devices descend from it; 2 cite 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)
- K061940: Synthes LCP Ankle Arthrodesis Plates, Synthes (Usa) (2006) Summary page 1.
- K060473: TTC Plate, New Deal, S.A. (2006) Summary page 1.
- K073375: Newdeal Tibiaxys System, Newdeal Sas (2008) 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 Ascension Ankle Fusion Plate System is intended for the following: >Arthrodesis of the ankle joint and tibia Fractures, osteotomies, fusions, and replantations of small bones in the foot and ankle.

Source page: https://510kreport.com/device/K100176
Methodology: https://510kreport.com/methodology