The trend of “personalized medicine” continues to grow thanks to 3D printing/ additive manufacturing (3DP/AM). Contributing to developments in personalized medicine is BioArchitects, which received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its 3D 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 face with self-tapping titanium screws.
This first of its kind U.S. device makes use of 3DP/AM technology from Arcam AB, 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.
Implants 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 computer design program. Biomedical engineers use the program to create a template of the repair that then becomes the model a 3D printer uses to produce 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.
Arcam has been a strategic supplier to the orthopedic market for more than a decade and tens of thousands of implants are made yearly from its EBM systems.