A man has had 75% of his skull replaced by a 3D printed copy in a first of its kind procedure.
The unnamed man from the US had his head scanned first prior to the procedure prior to the plastic prosthetic being grafted to his existing skull. The company behind this incredible technology is the Connecticut based Oxford Performance Materials who have only recently received FDA 510(k) clearance for the OsteoFab™ Patient Specific Cranial Device (OPSCD). OsteoFab is OPM’s brand for Additively Manufactured medical and implant parts produced from PEKK polymer. The cranial implant that was used in the procedure is made up from polyetherketoneketone (PEKK) which is then grown layer-by-layer directly from a digital CAD file and requires no external tooling and has very few practical limits on what can be produced. The material also allows for natural growth for cells and bones as well along with replacing bony voids in the skull due to trauma or disease The FDA approval of this device is the first of its kind for an additively manufactured polymer implant. PEKK is also unique in that is biocompatible, mechanically similar to bone, and radiolucent so as not to interfere with X-Ray equipment. This could now allow up to 500 recipients per month in the US to benefit from this technology, ranging from injured construction workers through to wounded soldiers.
Scott DeFelice, the CEO of OPM made the following statement after the FDA approved the technology:
“It is our firm belief that the combination of PEKK and Additive Manufacturing (our OsteoFab™ technology) is a highly transformative and disruptive technology platform that will substantially impact all sectors of the orthopedic industry,” said Scott DeFelice, President and CEO of OPM. “We have sought our first approval within cranial implants because the need was most compelling; however, this is just the beginning. We will now move systematically throughout the body in an effort to deliver improved outcomes at lower overall cost to the patient and healthcare provider.”