Zhorbot 300 Spine Surgery Navigation Robot

Developed by ZOEZEN (铸正机器人), the Zhorbot 300 is a spine surgery navigation robot designed for percutaneous pedicle screw fixation procedures. The system received NMPA Class III medical device certification in February 2022, establishing ZOEZEN as a participant in China’s growing spine surgery robotics market.

Product Overview

The Zhorbot 300 represents ZOEZEN’s first commercially available spine surgery robot, incorporating frameless stereotactic positioning technology developed through the company’s collaboration with Beihang University’s Medical Robotics Laboratory. Unlike systems requiring external tracking frames attached to patients, the Zhorbot 300 uses image-based registration and optical tracking to guide surgical instruments to planned trajectories.

The system addresses a specific clinical need: enabling robot-assisted spine surgery under local anesthesia. Traditional spine robots typically require general anesthesia and extensive setup procedures. The Zhorbot 300’s design simplifies workflow to support outpatient procedures and ambulatory surgery settings where local anesthesia is preferred.

Key Features

Frameless Stereotactic Positioning: The system eliminates the need for rigid frame attachment to the patient, reducing setup time and patient discomfort while maintaining navigation accuracy.

Image Fusion Technology: Preoperative CT scan data is registered with intraoperative fluoroscopy images, creating a composite 3D model for real-time surgical guidance.

Intuitive Image-based Localization: The Zhorbot 300 employs direct image-based positioning rather than relying solely on external optical markers, simplifying the surgical workflow.

Local Anesthesia Compatibility: System design supports procedures performed under local anesthesia, expanding application to settings where general anesthesia may not be available or appropriate.

Modular Architecture: The system integrates with existing hospital imaging equipment including standard C-arm fluoroscopy units, reducing capital investment requirements.

Technical Specifications

For percutaneous spine surgery, ZOEZEN’s Zhorbot 300 provides frameless stereotactic navigation with CT-fluoroscopy image fusion, NMPA Class III approved in February 2022.

Clinical Applications

The Zhorbot 300 is indicated for navigation assistance during:

• Percutaneous Pedicle Screw Fixation (PPSF): Primary application for thoracolumbar burst fractures and degenerative conditions requiring spinal stabilization
• Vertebroplasty and Kyphoplasty: Guidance for vertebral augmentation procedures treating compression fractures
• Spinal Fusion: Navigation support for lumbar and thoracic fusion procedures
• Biopsy: Precise needle placement for spinal lesion sampling

A retrospective clinical study published in Scientific Reports (2025) evaluated the Zhorbot system in 41 patients undergoing PPSF for thoracolumbar burst fractures. The robot-assisted group demonstrated reduced fluoroscopy frequency, decreased operative time, and lower estimated blood loss compared to conventional C-arm guided procedures. Screw placement accuracy, assessed using the Gertzbein-Robbins scale on postoperative CT, showed improved precision in the robot-assisted cohort.

Regulatory Status

NMPA Registration Number: 20223010268

The Zhorbot 300 holds Class III medical device certification from China’s National Medical Products Administration, the highest regulatory classification for medical devices indicating significant risk and requiring premarket approval with clinical data.

Frequently Asked Questions

What procedures is the Zhorbot 300 designed for?

The Zhorbot 300 is specifically designed for minimally invasive spine surgery, with primary application in percutaneous pedicle screw fixation (PPSF) procedures. It provides navigation assistance for treating thoracolumbar fractures, degenerative spine conditions, and other pathologies requiring spinal instrumentation.

How does the Zhorbot 300 differ from other spine robots?

The Zhorbot 300 distinguishes itself through frameless stereotactic positioning that eliminates the need for external tracking frames attached to patients. Additionally, its compatibility with local anesthesia procedures makes it suitable for outpatient and ambulatory surgery settings, unlike many competing systems that require general anesthesia.

What imaging equipment is required?

The Zhorbot 300 is designed to integrate with standard hospital imaging equipment, including conventional C-arm fluoroscopy systems. Preoperative CT scans are required for surgical planning and image fusion, but the system does not require specialized intraoperative CT or O-arm imaging.

Is the Zhorbot 300 available outside China?

Currently, the Zhorbot 300 is approved only for use in mainland China through NMPA certification. ZOEZEN has not announced applications for CE Mark (Europe) or FDA clearance (United States) as of early 2026.