The First 3D Printed Polymer Implant to Receive FDA Approval

Oxford Performance Materials (OPM), member of the National Additive Manufacturing Innovation Institute and producer of biomedical raw materials and devices, has just received FDA approval for its OsteoFab™ Patient Specific Cranial Device (OPSCD), making it the first 3D-printed polymer implant to pass the standards of the FDA, the US’s Food and Drug Administration.

Until 2006, the company focused its efforts on PEKK, a bone-like, biocompatible material used to replace the traditional steel and titanium implants of the past.  Since then, however, OPM has been working on printing its own implants made of PEKK, including the FDA-approved cranial device. CT scans and MRIs can give the dimensions needed for a biomedical device and, through selective laser sintering (SLS), which, by fusing bits of the PEKK polymer together, OPM can create implants that are tailored to the exact specifications of a patient.

The benefits of their trademark material are that they behave very similarly to bone, making it ideal for acceptance by a recipient’s body where they can remain for longer periods of time than metal implants. According to OPM’s website, the material has a “density [and] stiffness similar to bone”, is resistant to abrasion, can be easily sterilized for implantation, does not disrupt X-rays (compared with its metal counterparts) and is “osteoconductive”, which means that, as Wikipedia puts it, the “material serves as a scaffold for new bone growth that is perpetuated by the native bone.”

While the company has only just had its cranial device FDA approved, OPM’s CEO, Scott DeFelice, has explained that “[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.” OPM also plans to create a database of their various polymers for members of NAMII so that “aerospace and other engineers [can] design lightweight, efficient structures…[to] extend their range and utilize less energy.”

The FDA approval of OPM’s first biomedical device paves the way for more 3D-printed medical devices to come which will, ultimately, lead to more affordable, less toxic and more customized implants with a quicker turn-around time, overall.

Source: OPM