Caduceus S AR Spine Navigation System

Developed by Taiwan-based SURGLASSES, the Caduceus S AR Spine Navigation System combines augmented reality and mixed reality technologies to provide surgeons with real-time 3D visualization of patient spine anatomy during surgical procedures. The system received FDA 510(k) clearance in December 2022, following TFDA Class II approval in August 2022.

Product Overview

Caduceus S addresses the challenge surgeons face when performing complex spine procedures: the need to constantly shift attention between the patient and external monitors displaying imaging data. By projecting a 3D spinal model directly into the surgeon’s field of view through a transparent head-mounted display, the system allows continuous focus on the operative field while accessing navigation guidance.

The system requires only 2-4 C-arm X-ray shots to generate its navigation model, significantly reducing radiation exposure compared to traditional navigation methods that may require continuous fluoroscopy. This approach makes advanced navigation accessible to smaller facilities without dedicated O-arm or intraoperative CT equipment.

Key Features

Caduceus S’s AR overlay onto the surgeon’s field of view replaces the constant monitor-to-patient gaze shift that slows conventional spine navigation.

• Transparent Head-Mounted Display: Maintains 100% surgeon field of view while overlaying navigation data
• 3D Anatomical Superimposition: Projects preoperative spine model directly onto patient anatomy in real-time
• Trajectory Guidance: Displays planned screw entry points, angles, and depths during insertion
• Low Radiation Protocol: Requires only 2-4 C-arm images for full navigation setup
• Multi-Tracker System: Maintains registration accuracy throughout surgical movement

Technical Specifications

Caduceus S’s sub-1.5mm positioning accuracy, validated across 24 cadaveric screw insertions, underpins a 98.2% clinical accuracy rate on the Heary and Gertzbein scales.

Clinical Applications

Caduceus S is designed for complex spinal surgeries where precise instrumentation placement is critical:

• Pedicle Screw Insertion: Provides entry point identification, angle calculation, and depth measurement for thoracic and lumbar screws
• Scoliosis Correction: Supports multi-level instrumentation in deformity cases
• Minimally Invasive Spine Surgery: Enables smaller incisions by reducing the need for anatomical landmark exposure

The first-in-human surgery using Caduceus S was performed in October 2022 in Taiwan for a scoliosis case with 58° curvature. By April 2023, the system had completed its first AR-assisted spine surgery in the United States.

Regulatory Status

Caduceus S was the first surgical AR imaging system approved by Taiwan’s FDA.

Clinical Evidence

Validation testing demonstrated:

• 98.2% accuracy using the Heary classification for thoracic screws and Gertzbein-Robbins scale for lumbar screws
• Positioning precision consistently under 1.5mm in cadaver studies
• 24 pedicle screw insertions performed by Dr. Chin-Chang Chang at Taipei Veterans General Hospital during validation

Frequently Asked Questions

How does Caduceus S compare to traditional spine navigation?

Unlike conventional navigation systems requiring O-arm or intraoperative CT, Caduceus S uses standard C-arm fluoroscopy with just 2-4 images. This reduces radiation exposure, shortens setup time, and lowers equipment requirements for facilities.

What training is required to use Caduceus S?

The system is designed for intuitive operation, but SURGLASSES provides training programs for surgical teams adopting the technology. The transparent display allows surgeons to maintain their natural operative technique while adding navigation overlay.

Is Caduceus S compatible with existing surgical instruments?

Yes, the system has been tested with pedicle screw systems from five major instrumentation companies during validation, demonstrating 97% accuracy across all platforms.