FDA Approval For Bioarchitects’ 3-D Printed Titanium Cranial Plate

BioArchitects has announced the 510(k) clearance by the U.S. Food and Drug Administration for the company’s 3-D printed 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 U.S. device makes use of cutting-edge 3-D printing technology from Arcam AB, also known as additive manufacturing, taking advantage of the properties of light weight and high tensile strength of the biocompatible titanium alloy made from Arcam’s Electron Beam Melting (EBM) technology.
 
“We are extremely proud to contribute to what we consider another major advance in the trend toward personalized medicine. We believe that this is yet another step toward what will ultimately become the new standard of care,” said Mark Ulrich, CEO of BioArchitects USA.
 
Devices of this kind are typically used in the repair of bony defects resulting from trauma, disease, or congenital abnormalities. As each device is specific to a single 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 highly sophisticated computer design program, which is used to create a template of the repair that becomes the model from which the 3-D printer produces the titanium plate, to the specific dimensions of the design. The resulting plate is the exact fit for the defect, not unlike the positioning of a jigsaw puzzle piece. Getting from CT scan or MRI, the finished plate is the end product of collaboration between the surgeon and the biomedical engineer responsible for the design. 
 
“BioArchitects is a prime example of how innovative organizations are using EBM technology to advance biomedical surgeries that truly effect people’s lives,” said Magnus Rene CEO of the 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.”