Three Surgical Robots Receive NMPA Approval: Johnson & Johnson’s Transluminal Robot, Naton’s Unicompartmental Knee System, and MicroPort’s Hip-Knee Integrated Platform

Sep 16, 2023 00:01 CST Updated 00:01

Johnson & Johnson

Medical Device R&D and Manufacturer

MicroPort

High-end Medical Device R&D and Manufacturer

Source: MedRobot; Editor: Jacky

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On September 15, 2023, the National Medical Products Administration announced that three surgical robots had been approved.

They are Johnson & Johnson's natural orifice robot, Nitin's unicompartmental knee replacement robot, and MicroPort's hip-and-knee integrated robot.

# Through Natural Orifices

Johnson & Johnson's "Electronic Bronchoscope Navigation Control System" (Natural Orifice Robot),"Single-Use Electromagnetic Localization Electronic Bronchoscope Catheter"Product registration applications have been approved. The registration certificate numbers are "GuoXieZhuJin 20233060418" and "GuoXieZhuJin 20233010417", respectively.

This approval marks the successful launch of the first natural-orifice robot in China. (Intuitive Fosun's Ion is going through the innovation channel and has not yet been approved.)

Through the Monarch natural-orifice diagnostic and therapeutic robotic platform, doctors can precisely control the electronic bronchoscope to reach deep lesions within the patient's body via natural pathways without any incisions. This allows for the collection of lesion tissue samples for diagnosis, improving the diagnostic accuracy of peripheral pulmonary lesions such as small pulmonary nodules, and can also support minimally invasive treatments combined with ablation.The system helps timely diagnosis of early lung cancer and avoids delays in the condition. Precise localization prevents unnecessary lung tissue resection, minimizes patient trauma to a greater extent, saves medical resources, and benefits patients.

Comprehensive and Clear Intraoperative Field of View: Utilizing the world's first "three-in-one" endoscopic technology that integrates full-process visualization, electromagnetic navigation, and virtual reconstruction. After entering the human body, the endoscope can continuously display images, providing a comprehensive and clear intraoperative field of view.

Deep Lesions Easily Accessible:Driven by a flexible bronchoscope, it can easily reach deep lesions.
Precise and Flexible Control: The handle operates with precision and flexibility, allowing the flexible bronchoscope to achieve 360° angle adjustment.

# Unicondylar Replacement

Naton's "Knee Replacement Surgery Navigation and Positioning System" has been approved by NMPA and officially launched; it is the first domestically produced unicompartmental knee replacement surgical robot in China.

Naton Unicompartmental Replacement Robot:

Integrating human-machine collaboration operation concept, equipped with dual-power integrated control, capable of achieving full-process grinding support, compatible with multiple types of prostheses, and offering more flexible open adaptation.
With standardized operating procedures, more user-friendly human-machine interaction, modular function expansion, and upgradable platform for the future;
Advantages such as intelligent segmentation planning algorithms and submillimeter tracking accuracy.

Postoperative limb alignmentCompared to traditionalThe uniform surgical group is closer to the ideal state, shortening the patient's recovery cycle, improving the long-term prognosis of the surgery, and effectively shortening the learning curve for young doctors.

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Unicompartmental Knee Arthroplasty: Targeting patients with unicompartmental osteoarthritis of the knee, this procedure involves a minimally invasive surgery that replaces only the affected compartment's surface on one side of the knee joint. It focuses on replacing the damaged cartilage while preserving all ligamentous tissues and the articular cartilage of the remaining compartments, thereby facilitating rapid postoperative recovery.

Knee osteoarthritis is a common clinical condition. Approximately one-third of patients exhibit early-stage lesions confined to a single compartment, primarily the medial tibiofemoral compartment, with the other two joint compartments remaining unaffected. For these patients, total knee arthroplasty would result in the loss of healthy cartilage and ligaments in the unaffected compartments, causing excessive trauma and significant alterations in biomechanics.

# Hip and Knee Integration

September 2023On the 15th, MicroPort Robotics (02252) Suzhou MicroPort MedBot Co., Ltd.'s "Orthopedic Joint Replacement Surgical Navigation and Positioning System" approved by NMPA.The registration certificate number is "Guo Xie Zhu Zhun 20233011345".

Previously, the robot for knee replacement surgery (approved in China in 2022 with the registration number 20223010509) was approved.The joint replacement robot in this case is an integrated hip and knee system.

MicroPort's orthopedic robot brandSwan^®Robot, the robot isCurrently the first and only one equipped with self-Main intellectual property mechanical arm, and obtained in Asia, North America, Europe,South America, AustraliaCertifications from 5 continents (China NMPA, U.S. FDA, EU CE, Brazil ANVISA,Australian TGA Five Major Certifications), a domestically produced orthopedic surgical robot that can be marketed and sold in China, the United States, Europe, Brazil, and Australia.2023In the first half of the year, Honghu^®Robot achieves overseas sales.

Honghu®The orthopedic surgical robot consists of a navigation console (navigation cart, optical navigation equipment, display), surgical platform (mechanical arm, surgical cart), surgical auxiliary tools, optical positioning markers, foot pedal switch, and cables.

Swan®Can be used to assist in total knee arthroplasty (TKA), equipped with an independently developed robotic arm. Through the surgical process of preoperative CT scanning - establishing a 3D model - generating a personalized prosthesis implantation plan, and intraoperative robotic arm registration - bone registration - navigation positioning - precise osteotomy - prosthesis installation, it provides patients with an integrated orthopedic surgery solution.

As of mid-August 2023, the Honghu® Orthopedic Surgical Robot has completed over 600 robot-assisted clinical validation surgeries in more than 40 hospitals across 16 provinces in China, covering orthopedics, joint surgery, and sports medicine. These include several first-ever and highly complex robot-assisted procedures, such as the first 5G remote joint replacement surgery performed by a domestically produced surgical robot in China, joint replacement surgery following intramedullary nail fixation for femoral shaft fractures, and joint replacement surgery for severe rheumatoid arthritis. The successful completion of these high-difficulty surgeries demonstrates the increasing maturity of the Honghu® robot’s clinical application, fully adapting to and meeting the clinical requirements of orthopedic surgeries, while providing significant support for hospitals in conducting clinical practice and theoretical research.

At the same time, the Honghu® robot has successfully performed multiple 5G remote joint replacement surgeries, including the first 5G remote total knee arthroplasty assisted by a domestically produced robot in Tibet, promoting the application of Honghu in hospitals in third- and fourth-tier cities and remote areas, which has practical and far-reaching significance for the future construction of medical communities.

In terms of international expansion, as the first flagship product of MicroPort® Robotics Group to go overseas, the Honghu® robot has been continuously used for total knee replacement surgeries in multiple U.S. hospitals, including the Lighthouse Surgical Hospital in Hollis, New Hampshire. This ongoing application is steadily enhancing the global reputation and recognition of MicroPort Robotics, diversifying its international market channels, and will continue to provide global doctors and patients with superior, reliable, and comprehensive robotic surgical solutions.

In addition to its application in total knee arthroplasty, the MicroPort® Robotics Group is also exploring breakthrough applications of the Honghong® robot in other surgical procedures. The Honghong® robot has successfully completed the first total hip arthroplasty and the first unicompartmental knee arthroplasty in human surgeries, marking the official entry of Honghong into the substantive clinical validation phase for applications such as total hip arthroplasty and unicompartmental knee arthroplasty. (This status is based on preliminary information; it appears to have been approved currently. Further updates will be reported by MedRobot once the registration certificate content is updated.)

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