# K253379: Stealth AXiS Cranial clinical application

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Mar 26, 2026 after 177 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: 7 generations back to K050438 (2005). 9 ancestors in all.
No later device cites it as a predicate yet.
4 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212397: StealthStation S8 Cranial v2.0, Medtronic Navigation (2021) Summary page 5.

## Indications for use
The Stealth AXiS Surgical System, with the Stealth AXiS Cranial clinical application, is intended for precise positioning of surgical instruments and as an aid for locating anatomical structures in open, minimally invasive, and percutaneous neurosurgical 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. This can include, but is not limited to, the following cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures): • Tumor resections • General ventricular catheter placement • Pediatric ventricular catheter placement • Depth electrode, lead, and probe placement • Cranial biopsies

Source page: https://510kreport.com/device/K253379
Methodology: https://510kreport.com/methodology