It was learned that China's first 3D printed human implant was approved by the State Food and Drug Administration, and the National People's Congress representative, Liu Zhongjun, director of the Department of Orthopaedics of Peking University Third Hospital, who had been registered for 3D printing on several occasions, and Professor Zhang Ke The orthopedic joint research team was finally relieved. This “birth certificateâ€, which represents the stage of industrialization of 3D printed implants in China, has caused great shock in the industry, and it has made people see the hope of 3D printing technology in the medical field. Recently, China's first 3D printed human implant, artificial hip joint products, was approved by the State Food and Drug Administration. This product is also the first 3D printed artificial hip joint prosthesis registered in the world after clinical verification, which indicates that China's 3D printed implants have entered the stage of productization. This registered artificial hip joint product belongs to three types of orthopedic implants. It is the most supervised medical device product in China. It is produced by the Department of Orthopaedics of Peking University Third Hospital, Zhang Ke, Liu Zhongjun, Dr. Cai Hong and the largest artificial joint production in China. Enterprise - Beijing Aikang Yicheng Medical Equipment Co., Ltd. cooperated.
In 2009, Professor Zhang Ke, the head of the orthopedic joint group at the Third Hospital of Peking University, led the orthopedic joint team to introduce 3D printing technology into orthopedics. After 3 years, the company developed the first 3D printed artificial hip joint product in China. The clinical observation work of this product was led by the Third Hospital of Peking University, and was jointly completed by Beijing Jishuitan Hospital, Peking University People's Hospital, Shandong University Second Hospital and Wuhan Pu'ai Hospital. Since June 2012, a total of 32 patients have undergone 3D printed artificial hip surgery, and the clinical observation is effective.
Professor Liu Zhongjun, the first director of the Department of Orthopaedics, Peking University Third Hospital, who used the 3D printing technology to customize the pivotal treatment of atlantoscopic malignant tumors, pointed out that the successful registration of this product provides patients with an effective means of using advanced technology to treat diseases. After the localization of the product, it will break the monopoly of foreign products on the high-end market, greatly reduce the price, and save large medical expenses for patients; it is a milestone in promoting the development of the entire 3D printing industry chain.
Liu Zhongjun admits that the successful registration and approval means that 3D printed implants have been recognized.
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