China’s first total knee replacement surgery robot that has entered the special review process for innovative medical devices has been approved for marketing

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l Innovative medical devices, open implant data, and collaborative total knee replacement surgical robot were approved for marketing

l The first company in China that has the ability to develop all core components of an orthopaedic surgical robot system

l Self-developed collaborative orthopaedic surgery special robotic arm completes joint debugging with approved product components, and self-developed core components such as reducer and controller, optimize performance and improve surgical accuracy while greatly reducing product costs

l The software and hardware of the second-generation self-developed navigation system have been developed, and the cost is further reduced on the basis of the first-generation self-developed and approved products

l The total hip replacement surgery robot is expected to be approved for the market this year; the spine surgery robot starts the clinical plan discussion; the digestive tract product has completed the registration test; the natural orifice surgery robot has completed the research and development work, and will soon enter the clinical verification

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Recently, Gusheng Yuanhua Robot (Shenzhen) Co., Ltd. (hereinafter referred to as “Gusheng Yuanhua”), a wholly-owned subsidiary of Yuanhua Intelligent Technology (Shenzhen) Co., Ltd. (hereinafter referred to as “Yuanhua Intelligent”), independently developed Gusheng. Yuanhua Total Knee Replacement Surgical Robot received marketing approval from the National Medical Products Administration (NMPA), becoming the first and only open implant that entered the special review process of NMPA’s innovative medical devices (green channel) and was approved for marketing Object Data Total Knee Replacement Surgical Robot System.

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The total orthopaedic surgery robot system independently developed by Gushengyuanhua can assist doctors to complete various orthopaedic surgeries such as total knee replacement, total hip replacement, unicondylar knee replacement, spine and trauma. Gushengyuanhua total knee replacement surgery robot has broken the monopoly of foreign technology, and has self-developed navigation solutions and software systems. There is no need for osteotomy plates (or similar tools) to assist during the operation, and there is no need to use bone nails to fix the surgical site on the patient’s leg. The robotic arm assists doctors in the entire process of precise osteotomy in an intelligent and interactive way. As the only product of this type that has entered the NMPA special review process for innovative medical devices, under the leadership of the National Orthopaedic and Sports Rehabilitation Clinical Medicine Research Center, the First Medical Center of the Chinese People’s Liberation Army General Hospital, Sichuan University West China Hospital, Xinjiang Medical The First Affiliated Hospital of the University, Xiangya Hospital of Central South University, and the Second Affiliated Hospital of the Chinese People’s Liberation Army Army Medical University jointly completed a multi-center randomized controlled clinical trial study. The statistical results of the clinical trial show that the recovery accuracy rate of the force line of the robot group is 85.4%, and that of the manual control group is 65.6%, which fully proves that the product has higher accuracy than traditional surgery.

The total hip replacement surgery robot developed based on the same platform has been used in the First Medical Center of the Chinese People’s Liberation Army General Hospital, the West China Hospital of Sichuan University, the Fourth Medical Center of the Chinese People’s Liberation Army General Hospital, the Guangdong Provincial People’s Hospital, and the First Medical University of the Chinese People’s Liberation Army Army Medical University. The Second Affiliated Hospital and Ruijin Hospital Affiliated to Shanghai Jiaotong University have launched a multi-center randomized controlled clinical trial, which is expected to be approved for marketing this year.

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