News

January 24, 2019

3D-printed custom knee-joint orthosis wins FDA approval

A 3D-printed custom knee-joint orthosis, developed by a research team of Shanghai Ninth People’s Hospital affiliated to Shanghai Jiao Tong University School of Medicine, was approved by the FDA and put into use recently.

The Class II medical device, developed by the research team led by academician Dai Kerong and director Wang Jinwu, can offer more accurate and efficient medical treatment.

It is the first time that a scientific research institute has obtained the medical device registration certification since the Medical Device Registrant System was piloted within the Shanghai Free Trade Zone on December 1, 2017.

The eligible medical device registration applicants are now entitled to apply for a medical device registration certification independently, and then outsource the production to enterprises with qualification and production capacity.

The system is aimed at promoting the transformation of achievements in the area of medical devices development.