Mazor X System / Mazor X Stealth Edition

by Medtronic  · Based in Israel → — Engineering the extraordinary.
Neurosurgery Orthopedics
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Starts at $550,000 - $850,000
Regulatory Status Disclosed

Overview

The Mazor X System, including the Mazor X Stealth Edition, is a robotic guidance platform for spine surgery. Originally developed by Mazor Robotics, the technology was acquired by Medtronic in December 2018 and is now part of Medtronic’s portfolio of surgical solutions.

This integrated system combines advanced surgical planning software, robotic guidance, and real-time Stealth navigation to enhance precision and predictability in spinal procedures. Surgeons can utilize 3D planning functionality to design an optimal surgery in a CT-based simulation of the patient’s spine. During the procedure, a robotic arm helps execute the surgical plan with exceptional precision, while Stealth navigation provides real-time, intraoperative imaging feedback, allowing visualization of instruments and implants in relation to the surgical anatomy.

The Mazor X Stealth Edition is designed to improve surgical accuracy, reduce the risk of complications, lessen postoperative pain, and shorten hospital stays and recovery times for patients. It also aims to minimize exposure to ionizing radiation for both patients and operating room staff. The system can convert 2D fluoroscopic projections from standard C-arms into volumetric 3D images for enhanced visualization.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • 3D surgical planning functionality with CT-based simulation
  • Robotic guidance for precise execution of surgical plans
  • Stealth navigation for real-time intraoperative imaging feedback
  • Conversion of 2D fluoroscopic projections into volumetric 3D images
  • Customizable implant selection and trajectory planning
  • Minimally invasive surgery capabilities
  • Table-mounted robotic arm for small operating room footprint
  • Advanced anatomy recognition software
  • Real-time visualization of instruments and implants
  • Integration with Medtronic's StealthStation software

Use Cases

  • Anterior and lateral lumbar interbody fusion
  • Posterior lumbar and thoracic fusion
  • Minimally invasive lumbar decompression, discectomy, and cervical decompression
  • Correction of scoliosis, kyphosis, flatback, and cervical deformity
  • Spinal fracture fixation and spine tumor resection
  • Minimally invasive screw placement, vertebral interbody fusion, vertebral biopsy, and kyphoplasty

What Physicians Need to Know

DICOM Support & Standards
The Mazor X system utilizes 3D imaging capabilities to process and convert 2D fluoroscopic projections from standard C-Arms into volumetric 3D images. It also registers image data with patient anatomy by registering pre-operative CT scans to intra-operative fluoroscopic scans. The system can also pair images from different imaging modalities, such as matching a pre-operative CT with intra-operative fluoroscopy or 3D surgical imaging like the O-arm System.
PACS Integration Method
The system uses CT-based simulations for 3D planning functionality, allowing surgeons to design optimal surgery plans. Pre-operative CT scans with 1-mm-thick slices are loaded into the Mazor X software for planning purposes.
Reading Room Workflow Impact
The Mazor X Stealth Edition offers a fully-integrated procedural solution for surgical planning, workflow, execution, and confirmation. It allows for pre-operative or intra-operative planning and robotic and image-guided execution of multiple trajectories. The system aims to improve intraoperative workflow and efficiency, potentially leading to shorter time-per-screw placement and less fluoroscopy/radiation time.
AI Model Architecture (deep learning approach)
AI technology, including machine learning and deep learning, is extensively employed in spinal surgery to facilitate swift and accurate diagnosis, assist with preoperative planning and postoperative outcome prediction, and improve diagnostic efficiency. Medtronic's Stealth AXiS system, which builds on the Mazor robotic platform, connects with Medtronic's AiBLE ecosystem, combining AI, data, and services for personalized planning, surgical execution, and post-operative analysis.
Processing Speed (per study)
A study showed that from 2015 to 2019, the average robot time per screw improved from 7.2 to 5.5 minutes, and the average fluoroscopy time per screw improved from 15.2 to 9.4 seconds.
FDA Clearance Pathway (510k/De Novo)
The Mazor X Stealth Edition received FDA clearance in November 2018. The Mazor X System (Mazor X Stealth Edition) has received 510(k) clearance (K230064 and K251316). The system is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery.
Supported Modalities (CT/MRI/X-ray/US)
The system supports 3D planning functionality using CT-based simulations. It can match pre-operative CT with intra-operative fluoroscopy or 3D surgical imaging like the O-arm System. The Mazor X 3D imaging capabilities convert 2D fluoroscopic projections from standard C-Arms into volumetric 3D images. The Mazor X navigation tracks instrument positions in relation to surgical anatomy on diagnostic or intraoperative images.
Sensitivity & Specificity Data
According to published literature, robotic systems like the Mazor X have consistently demonstrated accuracy rates of 98% and higher in pedicle screw placement. Studies have shown that the Mazor X Robotic System enhances the accuracy of spinal surgeries by improving screw placement and reducing errors. One study reported 100% grade A accuracy on the Gertzbein-Robbins scale for the initial 90 pedicle screws placed using the Mazor X Stealth Edition robot.
Physician Tip

The Mazor X Stealth Edition combines surgical planning software, robotic guidance, and navigation for spinal procedures. It allows for 3D planning based on CT scans, enabling surgeons to design and simulate the optimal surgery. The robotic arm assists in executing the surgical plan with precision, and real-time imaging feedback helps ensure accuracy. The system is designed to enhance accuracy and consistency in various spinal conditions, including minimally invasive spine surgery, adult spinal deformities, and complex revision surgeries. It can help reduce radiation exposure for both patients and staff. While highly accurate, it's important to be aware of potential complications, as with any surgical procedure.

The Mazor X Stealth Edition integrates Medtronic's StealthStation software with the Mazor robotic platform. It also integrates with the Midas Rex™ MR8™ and Stealth-Midas™ high-speed drill systems. The system supports patient-specific rods and imaging tools, and connects with Medtronic's AiBLE ecosystem for AI-based planning and analysis. The system can register pre-operative CT scans with intra-operative fluoroscopy or 3D surgical imaging systems like the O-arm.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Starts at $550,000 - $850,000
DeploymentOn-premise
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Yes AI-estimated
GDPR Yes AI-estimated
Integrations
EHR Not specified
Specialties Neurosurgery, Orthopedics

What the Web Says

The Medtronic Mazor X System and Mazor X Stealth Edition are robotic guidance platforms designed to assist surgeons in spine surgery, particularly for pedicle screw placement and spinal fusions. They integrate advanced surgical planning software, robotic guidance, and real-time navigation to enhance precision and control during procedures. While generally praised for improving accuracy and enabling minimally invasive approaches, there have been significant concerns regarding potential hardware malfunctions and software errors that could lead to patient injury.

Overall: Mixed

Strengths

  • Enhanced precision and accuracy in screw placement, often reported at 98-100%.
  • Enables minimally invasive surgery, leading to smaller incisions, less tissue damage, reduced blood loss, and lower infection risk.
  • Potentially reduces postoperative pain, shortens hospital stays, and accelerates patient recovery.
  • Provides advanced surgical planning capabilities with 3D visualization and analytics.
  • Reduces radiation exposure for both patients and surgical staff.
  • Offers greater control and confidence for surgeons, especially in complex procedures.

Limitations

  • Risk of unexpected detachment from the operating room table due to pneumatic system leaks, potentially causing injury to the patient.
  • Software errors can lead to incorrect surgical instrument positioning, potentially causing nerve root injury, spinal cord injury, or chronic pain.
  • Navigation inaccuracies have been reported, where the system displays incorrect information about instrument location.
  • Higher cost compared to some other systems, with longer adoption curves due to system complexity.
  • Potential for robot-related complications, including nerve injuries and dural tears, sometimes requiring reoperation.
  • Longer system setup and planning-to-in-position times compared to some other robotic systems.

Based on reviews from: meyers-flowers.com, anapolweiss.com, youtube.com, nih.gov, thespinemarketgroup.com, beckersspine.com, rawlslawgroup.com, myacare.com, nationalmalpracticelawyers.com, orthoindy.com, therobotreport.com, baxterhealth.org, topdoctors.co.uk, mercy.com, medtechdive.com, iredellneurospine.com, brownhealth.org, uhhospitals.org, fiercebiotech.com

Last updated: 2026-10-31

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Press & Coverage

Orthopedic Design & Technology
Medtronic Launches Mazor X Stealth Edition for Robotic-Assisted Spine Surgery
Medtronic announced the first U.S. patients were treated with the Mazor X Stealth Edition for spine surgery following its commercial launch. The system integrates surgical planning, workflow, execution, and confirmation, and was first used at Norton Healthcare and Reston Hospital Center.
2019-01
Medical Design and Outsourcing
Medtronic to acquire Mazor Robotics for $1.6B
Medtronic announced its plan to acquire Mazor Robotics for over $1.5 billion, with early indications of their combined efforts including a Mazor X system integrated with Medtronic's StealthStation surgical navigation technology. This acquisition aims to advance robotic-assisted spine surgery by providing real-time image guidance and 3D planning.
2018-10
BoneZone
Medtronic Expands Mazor Robotics Partnership to Phase II
Medtronic entered Phase II of its strategic partnership with Mazor Robotics, gaining exclusive global distribution of the Mazor X surgical robotic assistance platform and making a $40 million investment. This phase includes Medtronic assuming commercialization of Mazor X and co-developing spine products.
2017-09
Medical Design and Outsourcing
Mazor Robotics Debuts Mazor X, Medtronic Ups Investment
Mazor Robotics debuted the Mazor X, a guidance platform for spine surgeries, ahead of its official commercial launch, while Medtronic increased its investment in Mazor Robotics by $20 million. The Mazor X offers pre-operative analytics, a robotic surgical arm, and real-time verification technology.
2016-07
OAE Publishing Inc.
Robotic-Assisted Spine Surgery: An Overview of Current Systems and Future Directions
The Mazor X Stealth Edition (cleared in 2018) is highlighted as a system that streamlines operative navigation by integrating preoperative and intraoperative 3D visualization/implant trajectory tracking software and various surgical tools. It has been cited for facilitating accurate pedicle screw placement.
2024-11
IntechOpen
Robotic-Assisted Spine Surgery
This chapter provides an overview of robotic technology in minimally invasive spine surgery, noting the Mazor X Stealth System (2016) as a key development following earlier Mazor platforms. It emphasizes the system's role in enhancing precision and mitigating complications.
2024-12

Videos

Product demos, reviews, and walkthroughs for Mazor X System / Mazor X Stealth Edition.

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Frequently Asked Questions

The Mazor X System integrates radiology imaging and AI for comprehensive surgical planning and execution. It uses CT-based images to create 3D models of the spine, allowing surgeons to virtually plan screw trajectories, optimize implant placement, and simulate procedures before entering the operating room. During surgery, the system tracks instrument positions in real-time relative to the patient's anatomy and diagnostic or intraoperative images, such as 2D fluoroscopic projections converted into volumetric 3D images. This AI-supported planning includes spinopelvic measurements and initial pedicle screw placement suggestions, with the surgeon retaining ultimate approval of the operative plan.
The Mazor X System, including its Stealth Edition, has received FDA clearance for its AI-supported functions. Specifically, the FDA accepted two bounded, locked-AI planning functions for spinopelvic measurements and initial pedicle-screw Plan Assist, based on retrospective measurements and expert plan-acceptability validation. It's important to note that this clearance does not prove autonomous planning, screw-placement accuracy, fewer complications, improved outcomes, or safety for every software version. There have been Class 2 FDA recalls related to the Mazor X Stealth Edition's "Snapshot" function due to potential navigation inaccuracies.
One significant concern is the potential for inaccurate navigation data, which can lead to instruments being guided to the wrong location during surgery. The system also has limitations in certain patient populations, such as those with severe obesity or osteoporosis, which may affect the accuracy of robotic nail placement. Additionally, the AI functions are not self-learning or autonomous robotic control systems, and their validation has not included prospective surgical workflow, placement accuracy, complication, or patient outcome evidence. There have also been hardware detachment issues with some Mazor X systems.
Several alternative robotic systems for spine surgery integrate radiology imaging. These include ExcelsiusGPS (Globus Medical), ROSA ONE (Zimmer Biomet), and Cirq (BrainLab). Other systems like Velys Spine (DePuy Synthes), Mako Spine (Stryker), Dynamis (LEMS Surgical), Cuvis-spine (Curexo), and Remi (Alphatec) also offer robotic guidance with imaging capabilities. These systems vary in their design, mounting methods, and imaging compatibility, with some offering real-time intraoperative navigation and 3D imaging.
The Mazor X robot typically costs between $550,000 and $850,000. In addition to the initial purchase price, there is a disposable supply cost of approximately $1,500 per case. While specific pricing for radiology imaging components is not separately detailed, the system integrates with preoperative CT scans and intraoperative fluoroscopic imaging, which would incur their own associated costs.
The Mazor X System utilizes preoperative CT scans and can convert 2D fluoroscopic projections from standard C-arms into volumetric 3D images. This allows for the registration of image data with patient anatomy by matching preoperative CT scans to intraoperative fluoroscopic scans. The system's software enables surgeons to plan procedures based on these images, and the Mazor X Stealth Edition integrates with Medtronic's StealthStation navigation for live tracking and visualization of instruments in relation to the patient's anatomy and planned paths. While direct integration with PACS is not explicitly detailed, the system's ability to import and process CT data implies compatibility with standard imaging workflows.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-18 | First Added: 2026-04-18
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