# K253381: Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Feb 12, 2026 after 135 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: 20 generations back to K911783 (1994). 74 ancestors in all.
No later device cites it as a predicate yet.
4 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251316: Mazor X System / Mazor X Stealth Edition, Mazor Robotics, Ltd. (2025) Summary page 5.
- K162309: StealthStation S8 System Platforms and StealthStation Cranial Software, Medtronic Navigation, Inc. (2017) Summary page 5.
- K251282: StealthStation S8 Spine Software, Medtronic Navigation, Inc. (2025). Cleared while this submission was under review Summary page 5.

## Indications for use
The Stealth AXiS™ Surgical System is intended for precise positioning of surgical instruments and as an aid for precisely locating anatomical structures in open, minimally invasive, and percutaneous procedures. The Stealth AXiS™ Surgical System is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. The Stealth AXiS™ Surgical System is indicated for precise robotic positioning of surgical instruments or implants during orthopedic or neurosurgery. It may be used in open, minimally invasive, and percutaneous procedures. The Stealth AXiS™ Surgical System, with the Stealth AXiS™ Spine clinical application, is intended for precise positioning of surgical instruments and as an aid for precisely locating anatomical structures in open, minimally invasive, and percutaneous procedures. Their use is indicated for medical conditions 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 procedures in adult patients, such as: •Interbody device placement • Pedicle screw placement •Iliosacral screw placement This can include the following spinal implant procedure in skeletally mature pediatric (adolescent) patients: • Pedicle screw placement

Source page: https://510kreport.com/device/K253381
Methodology: https://510kreport.com/methodology