# K153660: StealthStation System with Cranial Software

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Sep 14, 2016 after 268 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 3 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K050438 (2005). 3 ancestors in all.
144 later devices descend from it; 4 cite it directly.
7 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150216: Synergy Cranial, Medtronic Navigation, Inc. (2015) Summary page 5.
- K992927: Stealthstation Treatment Guidance Platform, Surgical Navigation Technologies, Inc. (1999) Summary page 7.

## Most influential descendants
- K170011: StealthStation S8 Spine Software v1.0.0 (2017), 126 descendants of its own
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module (2019), 42 descendants of its own
- K162309: StealthStation S8 System Platforms and StealthStation Cranial Software (2017), 39 descendants of its own
- K190929: xvision Spine system (XVS) (2019), 31 descendants of its own
- K222270: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments (2022), 23 descendants of its own

## Recalls of this device
- Apr 11, 2023 · Class I · Z-1666-2023: In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placemen
- Aug 9, 2019 · Class I · Z-1995-2020: Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System and auto-registrati
- Sep 26, 2018 · Class I · Z-0552-2019: An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of healthy tissue.

## Indications for use
The StealthStation System, with StealthStation Cranial Software, is intended to aid in locating anatomical structures in either open or percutaneous neurosurgical procedures. The system is indicated for any medical condition in which reference to a rigid anatomical structure 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): - Cranial Biopsies - Deep Brain Stimulation (DBS) Lead Placement - Depth Electrode Placement - Tumor Resections - Craniotomies/Craniectomies - Skull Base Procedures - Transsphenoidal Procedures - Thalamotomies/Pallidotomies - Pituitary Tumor Removal - CSF Leak Repair - Pediatric Ventricular Catheter Placement - General Ventricular Catheter Placement The user should consult the "Navigational Accuracy" section of the User Manual to assess if the accuracy of the system is suitable for their needs.

Source page: https://510kreport.com/device/K153660
Methodology: https://510kreport.com/methodology