• FDA Approval for a 3D Printed Titanium Cranial Plate • MedicalExpo e-Magazine
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    #14 - 3D Printing in Medicine

    FDA Approval for a 3D Printed Titanium Cranial Plate

    Courtesy of BioArchitects

    It’s a new step for 3D printing in medicine. At the beginning of February, BioArchitects received clearance from the U.S. Food and Drug Administration (FDA) for its 3D printed patient-specific titanium cranial plate implant.

    BioArchitects uses Arcam’s Electron Beam Melting (EBM) technology to 3D print biocompatible titanium alloy implants designed for “the repair of defects in the non-loadbearing bones of the head and face,” according to the company, which operates both in the U.S. and Brazil. The implants help treat patients suffering from trauma, disease or congenital abnormalities.

    The process begins with a CT scan or MRI of the affected area. The scan is then imported into a highly sophisticated computer design program which is used to create a repair template. This is used as the model from which the 3D printer produces the titanium plate. Each custom plate is permanently attached to the skull and/or face with self-tapping titanium screws.

    The FDA had already approved craniofacial implants from Oxford Performance Materials in 2014.


    About the Author

    Celia Sampol has been a journalist for 15 years. She worked in Brussels and Washington for national medias (Agence France Presse, Liberation). She's now the editor-in-chief of MedicalExpo e-magazine.

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