# K163209: Fiagon Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Fiagon GmbH
- Decided: Sep 14, 2017 after 303 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: 4 generations back to K993239 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151156: Fiagon Navigation System, Fiagon GmbH (2016) Summary page 4.
- K150216: Synergy Cranial, Medtronic Navigation, Inc. (2015) Summary page 4.
- K141833: Stylet, 23CM, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker, Tracer Pointer, Touch-N-GO Pointer, Navigation, Medtronic Navigation, Inc. (2015) Summary page 4.

## Indications for use
The Fiagon Navigation System is intended as an aid for 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 - Pediatric Catheter Shunt Placement The user should consult the "Bench Accuracy" section of the User Manual to assess whether the accuracy of the system is suitable for their needs.

Source page: https://510kreport.com/device/K163209
Methodology: https://510kreport.com/methodology