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3D Printed Implant Approved by FDA and Used to Replace Part of Man's Skull

By Wesley Fenlon

This is your brain in 3D printing.

3D printing is working its way into the medical field in projects like the Robohand, a prosthetic built for a kid who had no fingers on his right hand. Prosthetics and 3D printing makes a likely couple--as prosthetics need to be customized person-to-person, working from a 3D model and printing in small batches fits the situation. But the latest medical implementation of 3D printing goes beyond prosthetics into the more delicate realm of implants. The idea moves from believable to incredible as soon as you hear about the first use case of a new 3D printed material called OsteoFab: a patient in the United States had 75 percent of his skull replaced with a custom-printed implant.

Oxford Performance Materials received FDA approval for OsteoFab in mid February. Their process starts with a CT or MRI scan of whatever area needs an implant. Within two weeks, that scan can be configured as a CAD file, printed out as a PEKK polymer, and used in surgery. "One very desirable use of patient specific implants and the indication for the OPSCD is cranial implants to replace bony voids in the skull due to trauma or disease," notes OPM.

Photo via Oxford Performance Materials.

OPM's site says the PEKK material is "biocompatible, mechanically similar to bone, and radiolucent so as not to interfere with X-Ray equipment." Surface details printed in the additive manufacturing process are designed to encourage cellular or even bone growth around the implant.

The original article about the patient surgery, published in Australia, doesn't specify exactly what the 75 percent figure refers to: the density of the skull, or perhaps the surface area? It's an impressive number either way. The recent FDA approval also poses long-term questions about the OsteoFab material.

Will the 3D printed implants be good for life, or break down after a certain period of time? Does the new material make surgery more or less expensive than it was before? And when can we start printing replacement skulls on the weekly MakerBot Mystery Build?