BioArchitects has announced the 510(k) clearance by the US Food and Drug Administration for the company’s additive manufactured patient specific titanium cranial/craniofacial plate implant. Designed for the repair of defects in the non-loadbearing bones of the head and face, each custom designed plate is permanently attached to the skull and/or face with self-tapping titanium screws.
This first of its kind in the US, the implant takes advantage of the light weight and high tensile strength properties of the biocompatible titanium alloy and is made using Arcam’s Electron Beam Melting (EBM) technology.
“We are extremely proud to contribute to what we consider another major advance in the trend toward personalised medicine. We believe that this is yet another step toward what will ultimately become the new standard of care,” stated Mark Ulrich, CEO of BioArchitects USA.
Devices of this kind are typically used in the repair of bone defects resulting from trauma, disease, or congenital abnormalities. As each device is specific to the individual, its construction begins with the taking of a CT scan or MRI of the affected area. The scan or image is then imported into a computer design program which is used to create a template of the repair that becomes the model from which the Additive Manufacturing system produces the titanium plate.
“BioArchitects is a prime example of how innovative organisations are using EBM technology to advance biomedical surgeries that truly effect people’s lives,” stated Magnus Rene, CEO of Arcam Group. “Arcam has been a strategic supplier to the orthopedic market for over a decade and tens of thousands of implants are made yearly from our EBM systems. It is clear that both BioArchitects and Arcam are advancing patient care with new technologies that will make a significant difference in the world of medicine for years to come.”