# K251282: StealthStation S8 Spine Software

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Oct 17, 2025 after 176 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: 5 generations back to K050438 (2005). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201189: Stealthstation S8 Spine Software v1.3.0, Medtronic Navigation, Inc. (2020) Summary page 5.

## Most influential descendants
- K254157: CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody (2026), 0 descendants of its own
- K253381: Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application (2026), 0 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 in adult and skeletally mature pediatric (adolescent) patients. 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 in adult patients, such as: • Pedicle Screw Placement • Iliosacral Screw Placement • Interbody Device Placement This can include the following spinal implant procedures in skeletally mature pediatric (adolescent) patients: • Pedicle Screw Placement

Source page: https://510kreport.com/device/K251282
Methodology: https://510kreport.com/methodology