# K170011: StealthStation S8 Spine Software v1.0.0

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation
- Decided: May 1, 2017 after 118 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K050438 (2005). 4 ancestors in all.
126 later devices descend from it; 11 cite it directly.
3 of 131 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.
- K153660: StealthStation System with Cranial Software, Medtronic Navigation, Inc. (2016) Summary page 5.

## Most influential descendants
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module (2019), 42 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
- K182077: Mazor X System (Mazor X Stealth Edition) (2018), 16 descendants of its own
- K212245: Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning (2022), 15 descendants of its own

## Indications for use
The StealthStation® System, with StealthStation Spine Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic 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 spine or pelvis, can be identified relative to images of the anatomy. This can include the following spinal implant procedures, such as: o Pedicle Screw Placement o Iliosacral Screw Placement o Interbody Device Placement

Source page: https://510kreport.com/device/K170011
Methodology: https://510kreport.com/methodology