# K221087: Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Jun 10, 2022 after 58 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K050438 (2005). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
4 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190672: StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1, Medtronic Navigation, Inc. (2019) Summary page 5.

## Most influential descendants
- K231976: StealthStation Cranial Software, v3.1.5 (9735585) (2023), 1 descendant of its own
- K243657: ClearPoint System (Software Version 3.0) (2025), 0 descendants of its own

## Recalls of this device
- Apr 11, 2023 · Class I · Z-1630-2023: During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other navigation
- 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

## Indications for use
Synergy Cranial v2.2.9: 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 StealthStation Cranial Software v3.1.4: The StealthStation System, with StealthStation Cranial software, is intended to aid in 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 (including stereotactic frame-based and stereotactic frame alternatives-based procedures): - Cranial biopsies (including stereotactic) - 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

Source page: https://510kreport.com/device/K221087
Methodology: https://510kreport.com/methodology