# K033619: Navigus Unibody Fiducial Marker System, Model FM-4000

- Pathway: 510(k) (Traditional)
- Applicant: Image-Guided Neurologics, Inc.
- Decided: Mar 2, 2004 after 105 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K250505: EZ-Fiducials (2025), 0 descendants of its own
- K233144: ClearPoint Bone Screw Fiducials (2024), 0 descendants of its own

## Indications for use
The Navigus Unibody Fiducial Marker System is intended to provide fixed reference point(s) in patients requiring stereotactic surgery in conjunction with CT imaging.

Source page: https://510kreport.com/device/K033619
Methodology: https://510kreport.com/methodology