# K102413: Fuze: Intramedullary Internal Fixation Nail

- Pathway: 510(k) (Traditional)
- Applicant: Vilex, Inc.
- Decided: Nov 14, 2011 after 447 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K982953 (1998). 13 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090857: Valor Ankle Fusion Nail System, Wrightmedicaltechnologyinc (2009) Summary page 1.
- K021786: Titanium Ankle Arthrodesis Nail, Biomet, Inc. (2002) Summary page 1.
- K043052: Trigen Hindfoot Fusion Nail, Smith & Nephew, Inc. (2004) Summary page 1.
- K051590: T2 Ankle Arthrodesis Nail, Howmedica Osteonics Corp. (2005) Summary page 1.
- K091788: Panta Nail (Dia. 10MM), Panta Nail XL, Newdeal Sas (2009) Summary page 1.

## Most influential descendants
- K191782: TTC Phantom Intramedullary Nail System (2019), 6 descendants of its own
- K201227: Phantom® Hindfoot TTC/TC Nail System (2020), 5 descendants of its own
- K210869: Phantom Hindfoot TTC/TC Nail System (2021), 2 descendants of its own
- K251850: Phantom® Hindfoot TTC/TC Nail System (2025), 1 descendant of its own
- K231231: MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices (2023), 1 descendant of its own

## Recalls of this device
- Apr 22, 2015 · Class II · Z-1721-2015: Incidence of breakage is higher than expected.
- Apr 22, 2015 · Class II · Z-1723-2015: Incidence of breakage is higher than expected.
- Apr 22, 2015 · Class II · Z-1722-2015: Incidence of breakage is higher than expected.

## Indications for use
The Vilex FUZE has the following Indications for Use Ankle Arthordesis, Tiblo-talo-calacaneal Arthrodesis

Source page: https://510kreport.com/device/K102413
Methodology: https://510kreport.com/methodology