# K082992: Axxion Light Guide

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements, Inc.
- Decided: Feb 18, 2009 after 134 days
- Product code: FST (Light, Surgical, Fiberoptic)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K042034 (2004). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904378: F.T.I. Medical Light Guide, Fiberoptics Technology, Inc. (1991) Summary page 2.
- K080367: Zimmer Mis Light, Zimmer Spine, Inc. (2008) Summary page 2.
- K042034: Nuvasive Maxcess Light Guide, Nuvasive, Inc. (2004) Summary page 2.

## Most influential descendants
- K101496: Cablecap Model: WLF, STZ, Acm (2010), 1 descendant of its own
- K113330: Cablecap (2012), 0 descendants of its own

## Indications for use
The Axxion Light Guide is intended to provide surgical site illumination from a high intensity light source.

Source page: https://510kreport.com/device/K082992
Methodology: https://510kreport.com/methodology