Oxford Performance Materials (OPM) out of South Windsor, CT has announced that it has received FDA 510(k) clearance for its new OsteoFab 3D printed cranial device. This marks the first approval for an additively manufactured polymer implant. The new OPM device is a cranial maxillo-facial (CMF) plate for skull reconstruction which can be used to replace up to 75% of the skull. Their device is made from PEKK (polyetherketoneketone), which has many of the desirable properties of the commonly used PEEK implant material — but it also has twice the compressive strength, making it an ideal material to replace any bone that counts user protection among its primary functions.

Founded in 2000 as a supplier of PEKK, OPM had an early head start in developing the Selective Laser Sintering (SLS) process used to fuse small grains of the material into complete parts. SLS is just one of many new 3D printing technologies that have burst on the manufacturing scene in the last few years. A P800 SLS machine made by EOS (Munich, Germany), enables OPM to produce the part quickly from a patient’s CT or MRI scan without significant investment in tooling.

Using SLS to 3D print metals, like titanium for example, is generally considered to be inferior to the full laser melt version (SLM) of the process. For polymer materials however, SLS is ideal because the part can be built without the obvious structural issues of fully melting your substrate, yet the mechanical properties of the parent material are still preserved at the grain interfaces of the finished product. Furthermore the “rough” surface typically associated with an SLS process is ideal for osteointegration and no polishing or other surface treatments, other than sterilization, are are needed.

According to Scott DeFelice, President and CEO of OPM, the company is seeking well-qualified partners to commercialize their technology for other site-specific implants. PEKK has mechanical properties similar to that of bone, and may have other promising bony/orthopaedic applications in the future.

Press release: OsteoFab™ Patient Specific Cranial Device Receives 510(k) Approval