# K150216: Synergy Cranial

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Jun 11, 2015 after 132 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: 1 generation back to K050438 (2005). 1 ancestor in all.
149 later devices descend from it; 5 cite it directly.
7 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050438: Stealthstation System Update, Medtronic Surgical Navigation Technologies (2005) Summary page 5.

## Most influential descendants
- K153660: StealthStation System with Cranial Software (2016), 144 descendants of its own
- 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

## 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
- Nov 11, 2021 · Class I · Z-0383-2022: Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the screen and may display an incorrect posi
- 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 Synergy® Cranial software, is intended as an aid for precisely 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: - Cranial Biopsies - Tumor Resections - Craniotomies/Craniectomies - Skull Base Procedures - Transsphenoidal Procedures - Thalamotomies/Pallidotomies - Pituitary Tumor Removal - CSF Leak Repair - Pediatric Catheter Shunt Placement - General Catheter Shunt Placement

Source page: https://510kreport.com/device/K150216
Methodology: https://510kreport.com/methodology