Mazor X System / Mazor X Stealth Edition
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
For surgeons, the Mazor X Stealth Edition offers enhanced precision and accuracy in spinal implant placement through advanced 3D pre-operative planning and real-time intra-operative guidance. This can facilitate minimally invasive procedures, potentially leading to smaller incisions, reduced blood loss, decreased post-operative pain, and faster patient recovery. The system also aims to reduce radiation exposure for both patients and surgical staff by optimizing imaging use during procedures.
The Mazor X Stealth Edition seamlessly integrates robotic guidance with Medtronic's StealthStation navigation technology. It is compatible with Medtronic's range of surgical instruments and tools and is part of the broader AiBLEu2122 surgical suite. The system effectively combines pre-operative CT/MRI data with intra-operative imaging modalities like fluoroscopy (C-arms) and 3D surgical imaging (O-arm System) for comprehensive surgical planning and execution.
Details
| Category | Radiology & Imaging AI, Surgical AI |
| Pricing |
Contact vendor
|
| Deployment | On-premise (surgical robot in operating room) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
Yes AI-estimated The Mazor X System has received multiple FDA clearances, with the Mazor X system itself approved in 2016. The Mazor X Stealth Edition (K251316), a modified version, is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery, including open, minimally invasive, or percutaneous procedures. Earlier Mazor Robotics products, such as SpineAssist (2004) and Renaissance (2011), also received FDA approval. |
| Integrations | |
| EHR | Not specified |
| Specialties | Neurosurgery, Orthopedics |
What the Web Says
The Mazor X System and its newer iteration, the Mazor X Stealth Edition, are robotic guidance platforms designed to enhance precision and safety in spinal surgeries. They integrate 3D imaging, planning software, and robotic assistance to guide surgeons during procedures like pedicle screw placement and spinal fusions. Physicians generally report improved accuracy, reduced complications, and better patient outcomes with the use of these systems.
Overall: MixedStrengths
- Improved accuracy in implant placement, with reported rates of 98% to 100% for pedicle screws.
- Reduced blood loss and shorter hospital stays for patients.
- Minimally invasive capabilities, leading to smaller incisions, less tissue trauma, and reduced postoperative pain.
- Decreased radiation exposure for both patients and surgical staff.
- Advanced surgical planning and intraoperative guidance with real-time imaging and navigation.
- Effective in complex cases, including revision surgeries and scoliosis correction.
Limitations
- High cost of the system and disposable supplies per case.
- Potential for inaccurate navigation data, which can lead to misplaced instruments and nerve injuries.
- Risk of hardware detachment from the operating table due to pneumatic system air leakage, potentially causing injury to the patient.
- Complication rates, including reoperations, have not necessarily decreased despite newer generation robots.
- Requires specialized training for surgeons and surgical teams.
- Limited widespread academic literature on the newest Stealth Edition due to its recent release.
Based on reviews from: Mya Care, OrthoIndy, PubMed, ResearchGate, Instituto Clavel, Becker's Spine Review, MedTech Dive, Children's Hospital Colorado, Mayfield Brain & Spine, Joseph Spine Institute, DOCS Health, Saint Francis Healthcare, Medtronic.com, YouTube (Seattle Science Foundation), YouTube (Medtronic)
Last updated: 2026-07-18
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