# K151156: Fiagon Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Fiagon GmbH
- Decided: Apr 1, 2016 after 336 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: 3 generations back to K993239 (2000). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150216: Synergy Cranial, Medtronic Navigation, Inc. (2015). Cleared while this submission was under review Summary page 4.
- K142024: Brightmatter Navigation System, Synaptive Medical, Inc. (2015) Summary page 4.

## Most influential descendants
- K163209: Fiagon Navigation System (2017), 0 descendants of its own

## Indications for use
The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The Fiagon Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of cranial surgery can be identified relative to a CT or MR based model of the anatomy. Example procedures include, but are not limited to: Cranial Procedures: - Craniotomies/Craniectomies (e.g., Tumor Resection) - Skull Base Procedures - Cranial Biopsies - General Catheter Shunt Placement

Source page: https://510kreport.com/device/K151156
Methodology: https://510kreport.com/methodology