TiRobot II Orthopedic Surgical Robot

TiRobot Product Family: TiRobot II (Spine & Trauma) | TiRobot Recon (Joint Replacement) | TiRobot Sirui (AI Full Platform)

TiRobot II represents Tinavi’s second-generation orthopedic surgical robot system, serving as the company’s primary commercial platform for spine and trauma surgery applications across Chinese hospitals.

Product Overview

Building upon the foundation established by TiRobot (Tianji 1.0), TiRobot II received NMPA Class III medical device approval in 2021. The system addresses full-segment spinal surgery spanning cervical, thoracic, lumbar, and sacral vertebrae, alongside trauma surgery covering pelvis, acetabulum, and extremity fractures.

Tinavi positions TiRobot II as an efficiency-optimized platform that simplifies robot-assisted surgical workflows while maintaining the precision capabilities of its predecessor. The system has been deployed in over 200 medical institutions across China, contributing to cumulative surgical volumes exceeding 120,000 cases by mid-2025.

Key Features

TiRobot II’s one-touch screw selection, sterile intraoperative display, and simplified C-arm registration reduce workflow interruptions across spine and trauma procedures.

• Integrated End-Effector Control: One-touch screw selection at the robotic arm terminal reduces instrument exchanges and workflow interruptions
• Sterile Surgical Display: Intraoperative touch screen enables real-time surgical planning adjustments without breaking sterile field
• C-Arm Tracker Integration: Simplified registration process reduces setup time and radiation exposure
• Dual Imaging Compatibility: Supports both 2D fluoroscopy and 3D intraoperative imaging for trajectory planning
• Multi-Segment Coverage: Single system addresses cervical through sacral spine plus trauma applications

Technical Specifications

Approved by NMPA in 2021 with CE MDR certification in August 2024, TiRobot II uses a 6-DOF optical tracking arm achieving Grade A pedicle screw placement in over 95% of cases.

Clinical Applications

TiRobot II assists surgeons in precise positioning of surgical instruments and implants, particularly for pedicle screw placement in spinal fusion procedures. Clinical studies published in peer-reviewed journals report Grade A screw placement (perfectly positioned per Gertzbein-Robbins classification) in over 95% of robot-assisted cases, compared to lower accuracy rates in freehand fluoroscopy-guided procedures.

Primary clinical applications include:

• Posterior spinal fusion with pedicle screw fixation
• Minimally invasive percutaneous pedicle screw placement
• Complex spinal deformity correction (scoliosis, kyphosis)
• Pelvic ring fracture fixation
• Acetabular fracture reduction and fixation
• Femoral neck fracture treatment

The system enables both open and percutaneous surgical approaches, with published data suggesting advantages in blood loss reduction and surgeon radiation exposure compared to conventional techniques.

Regulatory Status

The CE MDR certification obtained in August 2024 covers the spinal function module, enabling sales in EU member states and countries recognizing CE certification. CSA certification provides access to the Canadian market. FDA 510(k) clearance for the US market has not been pursued as of January 2026.

Frequently Asked Questions

What is the difference between TiRobot and TiRobot II?

TiRobot (Tianji 1.0) was approved in 2016 as China’s first domestically developed orthopedic surgical robot. TiRobot II (Tianji 2.0), approved in 2021, offers workflow optimizations including integrated end-effector control, sterile surgical display, and simplified C-arm registration while maintaining core navigation accuracy.

How accurate is TiRobot II for pedicle screw placement?

Published clinical studies report Grade A screw placement (Gertzbein-Robbins classification) in over 95% of robot-assisted cases. A comparative study against O-arm navigation found the TiRobot system achieved significantly higher accuracy rates with reduced deviation in both sagittal and transversal planes.

Can TiRobot II be used for minimally invasive surgery?

Yes, TiRobot II supports both open and percutaneous minimally invasive approaches. The system’s trajectory guidance enables percutaneous pedicle screw insertion with reduced surgical exposure compared to traditional open techniques.