# K090240: Monteris Medical Ufo

- Pathway: 510(k) (Traditional)
- Applicant: Monteris Medical,
- Decided: Aug 6, 2009 after 185 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
Longest line of descent: 1 generation back to K992304 (1999). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992304: Navigus Trajectory Guide, Model TG-XXXX, Image-Guided Neurologics, Inc. (1999) Summary page 2.
- K012366: Navigus II Trajectory Guide, Image-Guided Neurologics, Inc. (2001) Summary page 1.

## Most influential descendants
- K180854: Voyager Trajectory Array Guide (V-TAG) (2018), 2 descendants of its own
- K250893: Ball Joint Guide Array (66295) (2025), 0 descendants of its own
- K191400: Voyager Trajectory Array Guide (V-TAG) (2019), 0 descendants of its own

## Indications for use
The Monteris Medical UFOTM is intended to provide stereotactic guidance, placement and fixation for the operation of instruments or devices during the planning and operation of neurological procedures performed in conjunction with preoperative and(or) perioperative MR or CT imaging. These procedures include laser coagulation, biopsies, catheter placement and electrode procedures.

Source page: https://510kreport.com/device/K090240
Methodology: https://510kreport.com/methodology