# K162309: StealthStation S8 System Platforms and StealthStation Cranial Software

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Mar 31, 2017 after 226 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: 3 generations back to K050438 (2005). 5 ancestors in all.
39 later devices descend from it; 9 cite it directly.
4 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153660: StealthStation System with Cranial Software, Medtronic Navigation, Inc. (2016). Cleared while this submission was under review Summary page 6.
- K050438: Stealthstation System Update, Medtronic Surgical Navigation Technologies (2005) Summary page 6.
- K133444: Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System, Medtronic Navigation, Inc. (2014) Summary page 6.

## Most influential descendants
- K182077: Mazor X System (Mazor X Stealth Edition) (2018), 16 descendants of its own
- K200935: Mazor X (2020), 15 descendants of its own
- K203005: Mazor X (2020), 14 descendants of its own
- K211441: Navigated Anterolateral Disc Prep Instruments (2021), 9 descendants of its own
- K201175: StealthStation Cranial Software v1.3.0 (2020), 8 descendants of its own

## Recalls of this device
- Mar 26, 2024 · Class I · Z-1776-2024: Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.
- 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

## 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 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. The StealthStation™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation™ System 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, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Source page: https://510kreport.com/device/K162309
Methodology: https://510kreport.com/methodology