[Excerpt] Health Canada, the government arm that deals with national health, has approved its first Canadian-made 3D printed medical implant.
The 3D printed device is a customizable mandibular (lower jaw) plate for use in facial reconstruction surgery, predominantly for patients with oral cancer. It can also be used in conjunction with surgical guides for cutting and drilling operations.
Named the Specifit 3D mandibular plate, the implant was developed by the 3D Anatomical Construction Laboratory (LARA 3D) in Quebec City. LARA 3D is a part of Investissement Québec (CRIQ), an organization providing product development services for new enterprises. The creation of the implant was also supported by the university hospital CHU de Québec-Université Laval, orthopedic screw manufacturer Alkom Digital, and metal powder firm AP&C (a GE Additive company).
The LARA 3D laboratory was launched in late 2020 and was issued an ISO 13485 certification in April 2021, meaning it’s certified to produce new medical devices for end-use healthcare applications.
“We are extremely proud to announce Health Canada’s approval of the Specifit 3D mandibular plate,” said Dr Gaston Bernier D.M.D., Medical Chief of Dental Medicine & Oncology at CHU de Québec-Université Laval.
To read more, click on: HEALTH CANADA HAS APPROVED ITS FIRST CANADIAN-MADE 3D PRINTED MEDICAL IMPLANT