# K212397: StealthStation S8 Cranial v2.0

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation
- Decided: Dec 22, 2021 after 142 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K050438 (2005). 8 ancestors in all.
4 later devices descend from it; 3 cite it directly.
4 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203639: StealthStation Cranial Software v1.3.2, Medtronic Navigation, Inc. (2021) Summary page 4.

## Most influential descendants
- K212194: Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System (2023), 1 descendant of its own
- K253379: Stealth AXiS Cranial clinical application (2026), 0 descendants of its own
- K241327: Navient Image Guide Navigation System (955-NC-NC), Cranial (2025), 0 descendants of its own
- K233542: Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System (2024), 0 descendants of its own

## Recalls of this device
- Sep 27, 2023 · Class I · Z-0188-2024: Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.

## Indications for use
The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or 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/K212397
Methodology: https://510kreport.com/methodology