# K080367: Zimmer Mis Light

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Spine, Inc.
- Decided: Feb 22, 2008 after 10 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: 1 generation back to K042034 (2004). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042034: Nuvasive Maxcess Light Guide, Nuvasive, Inc. (2004) Summary page 1.

## Most influential descendants
- K082992: Axxion Light Guide (2009), 2 descendants of its own
- K101496: Cablecap Model: WLF, STZ, Acm (2010), 1 descendant of its own
- K122637: Lite Decompression System- Light Cable Model 48089999 (2012), 0 descendants of its own
- K113330: Cablecap (2012), 0 descendants of its own
- K090070: Invuity Britefield Mcculloch Retractor System (2009), 0 descendants of its own

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

Source page: https://510kreport.com/device/K080367
Methodology: https://510kreport.com/methodology