China's first 3D printed human implant is approved by CFDA
September 01, 2015 Source: Health
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On July 22, 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 implant has 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, Zhang Ke, head of the orthopedic joint group of the Third Hospital of Peking University, led the orthopedic joint team to introduce 3D printing technology into orthopedics. After 3 years, the first 3D printed artificial hip joint product in China was developed. 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.
Liu Zhongjun, the director of the Department of Orthopaedics of Peking University's Third Hospital, who used the 3D printing technology to customize the pivotal treatment of atlantoscopic malignant tumors, said that the successful registration of the product provided patients with an effective means of using advanced technology to treat the pain; After the localization of the products, 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, Director of Department of Orthopaedics, Peking University Third Hospital
Frankly, the successful registration and approval means that 3D printed implants have been recognized, and the first batch of products has been approved. Similar products developed in the future are also expected to be accelerated.
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