# K122637: Lite Decompression System- Light Cable Model 48089999

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Spine
- Decided: Nov 1, 2012 after 64 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.
- K080367: Zimmer Mis Light, Zimmer Spine, Inc. (2008) Summary page 1.

## Indications for use
The Stryker Spine LITe Decompression System - Light Cable is intended to provide surgical site illumination from a high intensity light source when Stryker decompression tubes are in use.

Source page: https://510kreport.com/device/K122637
Methodology: https://510kreport.com/methodology