# K153247: Fusion Compact Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Feb 18, 2016 after 101 days
- Product code: PGW (Ear, Nose, And Throat 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 K001284 (2000). 1 ancestor in all.
4 later devices descend from it; 2 cite 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)
- K001284: Stealthstation System Goldeneye Micro-Magnetic Tracking System, Medtronic Surgical Navigation Technologies (2000) Summary page 4.

## Most influential descendants
- K170018: StealthStationTM S8 ENT Software (2017), 3 descendants of its own
- K200723: StealthStation FlexENT  (9736242), StealthStation S8 ENT Software (9735762) (2020), 2 descendants of its own
- K253395: Stealth AXiS™ ENT clinical application (2026), 0 descendants of its own
- K223734: ENT EM (2023), 0 descendants of its own

## Indications for use
The Medtronic Fusion Compact computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous ENT procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy.

Source page: https://510kreport.com/device/K153247
Methodology: https://510kreport.com/methodology