Arcam AB announced that a new hip system from Beijing AK Medical is now formally approved by the Chinese State Food and Drug Administration. This is China's first CFDA marketing approval for an additively manufactured 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 Additively Manufactured implant in China. This confirms how our EBM technology is leading the way in additive manufacturing of implants”,
says Magnus René, CEO of Arcam.
“With this CFDA approval in place we look forward to a continued strong growth in the Chinese market”, says Jane Chen, General Manager of Arcam (Beijing) Industrial Equipment Ltd.
For more information, visit: www.arcam.com