# K201189: Stealthstation S8 Spine Software v1.3.0

- Pathway: 510(k) (Special)
- Applicant: Medtronic Navigation, Inc.
- Decided: May 29, 2020 after 28 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 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.
15 later devices descend from it; 8 cite it directly.
2 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170011: StealthStation S8 Spine Software v1.0.0, Medtronic Navigation (2017) Summary page 5.

## Most influential descendants
- K220241: “POINT” Kinguide Robotic-Assisted Surgical System (2022), 4 descendants of its own
- K230087: “POINT” Kinguide Agile Hybrid Navigation System (2023), 3 descendants of its own
- K251282: StealthStation S8 Spine Software (2025), 2 descendants of its own
- K241130: “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) (2024), 2 descendants of its own
- K213034: SpineAR SNAP (2022), 2 descendants of its own

## Recalls of this device
- Aug 22, 2024 · Class II · Z-0050-2025: Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flippe

## 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/K201189
Methodology: https://510kreport.com/methodology