Orthopedic · Products

ORTHBOT Spine Surgical Robot

Developed by FUTURTEC, ORTHBOT became China’s first orthopedic surgical robot with autonomous needle placement capabilities when it received NMPA approval in February 2021. The system combines intraoperative navigation with robotic execution, distinguishing it from navigation-only devices that guide but do not perform surgical maneuvers.

Product Overview

ORTHBOT addresses a fundamental limitation in conventional spine surgery: the difficulty of precisely translating preoperative plans into intraoperative execution. Traditional approaches rely on surgeons’ manual dexterity and fluoroscopic guidance, with accuracy depending heavily on individual skill and experience.

The system provides what FUTURTEC describes as “navigation plus execution”—not merely showing surgeons where to place instruments, but actively positioning and inserting K-wires under physician supervision. This approach reduces the hand-eye coordination challenges inherent in fluoroscopy-guided procedures while maintaining surgeon oversight of critical decisions.

Key Features

Autonomous K-Wire Placement: ORTHBOT physically inserts K-wires into pedicle entry points rather than simply indicating target locations. The robotic arm follows the planned trajectory while the surgeon monitors progress and retains override capability.

Non-Invasive Optical Tracking: Unlike systems requiring reference pins or fiducial markers implanted in the patient, ORTHBOT’s tracking solution integrates with the robotic arm itself. This eliminates additional operative steps and potential marker-related complications.

2D-Based Planning: The system generates intervention plans from C-arm X-ray images rather than requiring preoperative CT scans, reducing imaging burden and enabling use in facilities without CT capabilities.

Pressure Feedback Monitoring: Real-time force sensing during insertion provides tactile information about bone engagement and instrument positioning, alerting surgeons to unexpected resistance or trajectory deviations.

Full Spine Coverage: ORTHBOT supports procedures across the entire vertebral column from cervical to sacral levels, accommodating the varied anatomy and access requirements of different spinal regions.

Technical Specifications

Approved in China in February 2021, ORTHBOT handles cervical-to-sacral procedures using non-invasive optical tracking and 2D C-arm planning for autonomous K-wire execution.

ParameterSpecification
Navigation MethodNon-invasive optical tracking
Planning Imaging2D X-ray (C-arm)
Spine CoverageCervical to Sacral
Execution ModeAutonomous with physician supervision
Feedback SystemsPressure monitoring
Tracking AttachmentIntegrated with robotic arm

Clinical Applications

Pedicle Screw Placement

The primary application involves guiding and executing pedicle screw trajectory preparation across spinal levels. Studies of robotic spine surgery generally report improved accuracy compared to freehand techniques, with some systems achieving 96% of screws within 1mm of planned position.

Percutaneous Kyphoplasty (PKP)

For vertebral compression fractures, ORTHBOT assists with the percutaneous approach required for kyphoplasty procedures. The system plans and confirms the correct path in advance, reducing fluoroscopy time and potentially improving balloon and cement placement accuracy.

Spine Trauma Surgery

The robot supports trauma applications where rapid, accurate screw placement can reduce operative time and improve stabilization outcomes. The 2D-based planning accommodates emergency settings where preoperative CT may not be available.

Regulatory Status

RegionStatusDate
China (NMPA)ApprovedFebruary 2021
European Union (CE MDR)CertifiedMay 2023
United States (FDA)Not Cleared-

ORTHBOT’s NMPA approval marked it as China’s first spine surgical robot with active execution capabilities. The subsequent MDR CE certification in 2023 made FUTURTEC the first and only Chinese company with European orthopedic robot market authorization under the new Medical Device Regulation framework.

Frequently Asked Questions

What surgeries can ORTHBOT perform?

ORTHBOT supports pedicle screw placement across all spine levels (cervical through sacral), percutaneous kyphoplasty for vertebral compression fractures, and various spine stabilization procedures. The system handles both planning and execution phases of K-wire insertion.

How does ORTHBOT compare to navigation-only systems?

Navigation-only systems display target locations and trajectories but require surgeons to manually execute instrument placement. ORTHBOT adds autonomous execution—the robot physically positions and inserts K-wires while the surgeon supervises. This reduces reliance on manual steadiness and potentially improves consistency.

Does ORTHBOT require preoperative CT scans?

No. ORTHBOT generates plans from intraoperative 2D X-ray images captured with a standard C-arm. This distinguishes it from CT-based systems and enables use in facilities without CT access or in emergent situations.

What tracking method does ORTHBOT use?

ORTHBOT employs non-invasive optical tracking integrated into the robotic arm. Unlike systems requiring reference pins or markers fixed to the patient’s anatomy, ORTHBOT’s approach eliminates these additional implanted components.

Last modified: January 15, 2026

Sources

Publicly available references used for the data on this page. See data methodology for verification standards.