# K012366: Navigus II Trajectory Guide

- Pathway: 510(k) (Traditional)
- Applicant: Image-Guided Neurologics, Inc.
- Decided: Oct 1, 2001 after 67 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 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
- K090240: Monteris Medical Ufo (2009), 3 descendants of its own
- K180854: Voyager Trajectory Array Guide (V-TAG) (2018), 2 descendants of its own
- K162604: Cranial Reducing Tubes (2016), 1 descendant of its own
- K253663: Zeta Navigation System (2026), 0 descendants of its own
- K250893: Ball Joint Guide Array (66295) (2025), 0 descendants of its own

## Recalls of this device
- Oct 4, 2007 · Not classified · Z-0849-2008: Sterilty (package integrity) Compromised: Some failures were for damage to the outer pouch, while another set of failures were for the seals on this pouch. The seal between the inner tray and lid has 

## Indications for use
The Navigus II Trajectory Guide is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures performed in conjunction with the use of an Image Guided Workstation System using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placement and electrode introduction. The device is ETO sterilized and for one time use.

Source page: https://510kreport.com/device/K012366
Methodology: https://510kreport.com/methodology