FDA approves first non-metal 3D printed implants

Osteofab Cranial Device

More than 30,000 people already have 3D-printed hips that are made of titanium. That’s good, because titanium is light and strong, like bone. There are some drawbacks to having metal for bones, though (besides being susceptible to Magneto’s powers). For one, it interferes with X-rays, and two, MRIs are a no-go. And if you’re needing bone replaced in your head, where MRIs are often directed, that can be especially problematic. That’s why the FDA’s recent approval of Oxford Performance Materials’ 3D printed polymer for cranial bone replacement is a major milestone.

OPM is a member of NAMII, the National Additive Manufacturing Innovation Institute, and they’d been researching a biocompatible form of polyetherketoneketone, or PEKK, since 2006. The research was fruitful, bearing OsteoFab. What the FDA specifically approved is the OsteoFab Patient Specific Cranial Device (OPSCD), which is the first non-metal, 3D printed implant to receive such approval. OsteoFab is produced through selective laser sintering, which is very precise; using an MRI to determine the exact shape of the needed implant, combined with this OPSCD technology, will yield the best cranial implants to date. Not only is OsteoFab bone-like as far as strength and flexibility, but it’s also osteoconductive, meaning new bone will grow into it.

OsteoFab now has its bone-like foot in the FDA’s door, so the cranium is just the beginning, as Scott DeFelice, CEO of OPM, points out: “[OPM] will now move systematically throughout the body in an effort to deliver improved outcomes at lower overall cost to the patient and healthcare provider.” So expect OsteoFab femurs, tibias, and fibias in the very near future.

h/t: Fabbaloo