# K100925: Ascension Ankle Fusion Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedics, Inc.
- Decided: Jul 12, 2010 after 101 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K051590 (2005). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091976: Biomet Phoenix Ankle Nail and Ankle Arthrodesis Nail, Biomet Trauma (2009) Summary page 1.
- K051590: T2 Ankle Arthrodesis Nail, Howmedica Osteonics Corp. (2005) Summary page 1.

## Most influential descendants
- K163627: Shotel Ankle Arthrodesis Nail System (2017), 0 descendants of its own

## Indications for use
The Ascension® Ankle Fusion Nail System is intended for the following: * Charcot Foot * Avascular necrosis of the talus * Failed total ankle arthroplasty * Trauma (malunited tibial pilon fracture) * Severe deformity or instability as a result of talipes equinoivarus, cerebral vascular accident, paralysis or other neuromuscular disease * Revision ankle arthrodesis * Neuroarthropathy * Rheumatoid arthritis * Osteoarthritis * Pseudoarthrosis * Post-Traumatic arthrosis * Previously infected arthrosis * Severe end stage degenerative arthritis * Severe defects after tumor resection * Pantalar arthrodesis

Source page: https://510kreport.com/device/K100925
Methodology: https://510kreport.com/methodology