A new hip system made using Arcam’s electron beam melting (EBM) technology has been formally approved by the Chinese State Food and Drug Administration. This is reportedly China's first CFDA marketing approval for an additively manufactured (AM) orthopedic implant.
Beijing AK Medical, a Chinese orthopedics implant industry leader, and Professor Zhongjun Liu and Professor Ke Zhang of Peking University Third Hospital have been working closely together on this project. After six years of product design, biological tests, biomechanics and clinical validations, and regulatory approval processes, the 3D ACT hip system has finally received marketing authorization.
‘We are very happy that our customer Beijing AK Medical received this first ever CFDA approval for an AM implant in China,’ said Magnus René, CEO of Arcam. ‘This confirms how our EBM technology is leading the way in additive manufacturing of implants.’
‘With this CFDA approval in place we look forward to a continued strong growth in the Chinese market, added Jane Chen, general manager of Arcam (Beijing) Industrial Equipment Ltd.
This story is reprinted from material from Arcam with editorial changes made by Materials Today. The views expressed in this article do not necessarily represent those of Elsevier.
