A 3D printed skull implant has been approved by the U.S. Food and Drug Administration (FDA) and has already been used to help replace 75% of a patients skull.
3D printers are already showing promise in a variety of medical applications, both for bio-compatible medical implants and also for stem cell research, such as the 3D printed human ear. After receiving FDA approval the skull implant was used for the first U.S surgical operation on Match 4th.
The OsteoFab™ Patient Specific Cranial Device was developed by Oxford Performance Materials and has already been used internationally for the last year. FDA approval opens the door for these implants to be used on U.S. patients, of which there are potentially 300 to 500 per month who could benefit.
These patients include those with cancerous bone in their skulls, as well as auto accident victims and U.S. military servicemen and women who have suffered a severe head trauma.
A digital 3D scan of a patient’s skull is made and a 3D printed implant is produced in a special polyetherketoneketone (PEKK) material which is bio-compatible and suitable for human implants. The 3D print resolution is so good that they can even make tiny surface or edge details on the implant that encourages the growth of cells and allow skin to attach easily.
“We see no part of the orthopedic industry being untouched by this,” said Scott DeFelice, president of Oxford Performance Materials.
The next step is to develop 3D printed bone implants for other parts of the body, and Oxford Performance Materials have already started to submit other implants for FDA approval. The market is said to be worth from $50 million to $100 million for each bone replacement type.