# K182077: Mazor X System (Mazor X Stealth Edition)

- Pathway: 510(k) (Traditional)
- Applicant: Mazor Robotics, Ltd.
- Decided: Nov 2, 2018 after 93 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K911783 (1994). 67 ancestors in all.
16 later devices descend from it; 1 cites it directly.
4 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180307: Mazor X, Mazor Robotics, Ltd. (2018) Summary page 4.
- K170011: StealthStation S8 Spine Software v1.0.0, Medtronic Navigation (2017) Summary page 4.
- K162309: StealthStation S8 System Platforms and StealthStation Cranial Software, Medtronic Navigation, Inc. (2017) Summary page 4.

## Most influential descendants
- 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
- K240625: CORUS Navigation Access System (2024), 4 descendants of its own
- K230064: Mazor X System (Mazor X Stealth Edition) (2023), 3 descendants of its own

## Recalls of this device
- Dec 5, 2019 · Class II · Z-2330-2020: There is a potential for the surgical system to detach from the operational room table unexpectedly. This could result in the surgical system falling onto the patient resulting in blunt injury [hemorr
- Jul 2, 2019 · Class II · Z-0721-2020: The firm has become aware that the Snapshot Trackers were not manufactured in accordance with specifications and could potentially lead to navigational inaccuracies, which may result in patient injury

## Indications for use
The Mazor X is indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It may be used in open or minimally invasive or percutaneous procedures. Mazor X 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects. The Mazor X navigation tracks the position of instruments, during spinal surgery, in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient.

Source page: https://510kreport.com/device/K182077
Methodology: https://510kreport.com/methodology