# K230064: Mazor X System (Mazor X Stealth Edition)

- Pathway: 510(k) (Traditional)
- Applicant: Mazor Robotics, Ltd.
- Decided: Apr 7, 2023 after 88 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: 18 generations back to K911783 (1994). 70 ancestors in all.
3 later devices descend from it; 2 cite it directly.
4 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203005: Mazor X, Mazor Robotics, Ltd. (2020) Summary page 4.

## Most influential descendants
- K251316: Mazor X System / Mazor X Stealth Edition (2025), 1 descendant of its own
- K253381: Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application (2026), 0 descendants of its own
- K230716: Robotic Graft Delivery Instruments (2023), 0 descendants of its own

## Recalls of this device
- Dec 10, 2025 · Class II · Z-1122-2026: Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
- Jul 17, 2024 · Class II · Z-3156-2024: Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and the screw information

## Indications for use
The Mazor X is indicated for precise positioning of surgical instruments or spinal implants during general spinal 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 a 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/K230064
Methodology: https://510kreport.com/methodology