FDA Clearance for 3D-Printed Titanium Cranial/Craniofacial Implants

The US Food and Drug Administration (FDA) has given a 510(k) clearance to a 3D-printed titanium cranial/craniofacial implant manufactured by US- and Brazil-based company BioArchitects. This important news marks the start of the company’s marketing for the device in the US.

3D Printing is steadily becoming indispensable in the medical world, and BioArchitects uses this technology exclusively for all its production. Thanks to the development of metal 3D Printing, the company can create patient-specific, biocompatible implants to replace hard tissue.

The final products are extremely precise: they are modeled on CT and MRI scans of the patients themselves, based on an exact replica of the patient’s head.

Metal 3D Printing uses a process called Electron Beam Melting technology, which involves using electron beams to melt and fuse very fine metal powder. Made out of titanium alloy, the implant is attached to the patient’s cranium using self-tapping screws. It allows for a much more effective facial reconstruction, and the implants themselves are lightweight and completely safe for the human body.

Materialise software has aided us with the image processing, design and validation of the patient-specific implant“, said Felipe Marques, CEO of Brazil BioArchitects. The FDA clearance is not easy to obtain and an important factor in speeding up the procedure was the use of 510(k) cleared software in the implant design process.

The company can now start marketing the titanium implants on American soil. “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. The technology surrounding facial reconstruction in particular has made amazing progress due to the advances in medical 3D Printing, giving surgeons the capacity to reconstruct the faces of their patients more effectively than ever before.

original text available at