Naton Orthopedic Surgical Navigation System

Beijing Naton Medical Robotics Technology Co., Ltd. developed this orthopedic surgical navigation system that received NMPA Class III certification on August 7, 2024 (Registration No. 国械注准20243011427). The system supports both spinal and trauma orthopedic procedures, providing virtual visualization of patient anatomy and surgical instruments.

Product Overview

The Naton Orthopedic Surgical Navigation System addresses two distinct surgical applications: spinal pedicle screw insertion and trauma hollow screw implantation. The dual-indication design allows hospitals to deploy a single navigation platform across spine and trauma surgery departments, increasing equipment utilization.

The navigation function creates virtual visualization of patient bone structure and surgical tools, displaying the real-time relationship between instruments and patient anatomy. This enables procedures with smaller incisions, reduced bleeding, and lower intraoperative radiation exposure compared to conventional fluoroscopy-guided techniques.

Key Features

For spine and trauma surgery, Naton’s dual-indication navigation system provides real-time instrument visualization while reducing intraoperative radiation exposure.

• Dual Surgical Applications: Single platform supports both spine (pedicle screw) and trauma (hollow screw) procedures
• Real-time Visualization: Continuous display of instrument position relative to patient anatomy
• Reduced Radiation Exposure: Decreased need for intraoperative fluoroscopy through navigation guidance
• Virtual Bone Reconstruction: 3D visualization of patient bone structure from imaging data
• Minimally Invasive Approach: Navigation enables smaller incisions and reduced surgical trauma

Technical Specifications

For pedicle screw and hollow screw procedures, the system integrates optical navigation with intraoperative imaging under registration number 国械注准20243011427.

Clinical Applications

Spinal Surgery

The system guides pedicle screw placement in spinal fusion procedures. Accurate screw positioning is critical for achieving stable fixation while avoiding neural and vascular structures. Navigation reduces the risk of screw malposition and associated complications including nerve injury, vascular damage, and construct failure.

Trauma Surgery

For trauma applications, the system assists with hollow screw implantation in fracture fixation procedures. Cannulated screw placement benefits from navigation guidance, particularly in anatomically complex fractures where fluoroscopy alone provides limited visualization.

Regulatory Status

This approval represents Naton’s second NMPA-cleared surgical navigation product, following the knee joint navigation system approved in September 2023.

Frequently Asked Questions

What surgical procedures does this navigation system support?

The system supports two primary applications: spinal pedicle screw insertion for fusion procedures and trauma hollow screw implantation for fracture fixation. Both applications benefit from real-time navigation guidance to improve accuracy and reduce radiation exposure.

How does navigation reduce radiation exposure?

Traditional fluoroscopy-guided spine and trauma surgery requires repeated X-ray imaging to verify instrument position. Navigation systems provide continuous tracking without additional radiation, allowing surgeons to confirm positioning through the navigation display rather than fluoroscopy.

Can this system be used with existing surgical instruments?

The system is designed to integrate with Naton’s orthopedic implant portfolio. Specific instrument compatibility should be confirmed with the manufacturer based on the planned surgical procedure and implant system.