# K992304: Navigus Trajectory Guide, Model TG-XXXX

- Pathway: 510(k) (Traditional)
- Applicant: Image-Guided Neurologics, Inc.
- Decided: Aug 27, 1999 after 50 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.
6 later devices descend from it; 2 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)
- 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

## Indications for use
The Trajectory Guide is intended to provide stereotactic quidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI/CT environment and in conjunction with MR/CT imaging. The Trajectory Guide is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode introduction. The device will provide accurate delivery of devices or instruments to target sites 3mm and larger.

Source page: https://510kreport.com/device/K992304
Methodology: https://510kreport.com/methodology