First 510(k) Clearance for Customized 3D-Printed Polymeric Cranial Implants

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Oxford Performance Materials (OPM), South Windsor, Conn., made medical history in February when they received the first Food and Drug Administration (FDA) 510(k) clearance for their polymer laser-sintered OsteoFab Patient-Specific Cranial Device (OPSCD). The customizable implant is designed to restore voids in the skull caused by trauma or disease. Manufactured in a matter of hours with Additive Manufacturing (AM) technology from EOS, the implant saw its first use just a few days later, when the device was successfully implanted in a patient missing a significant portion of cranial bone. “It was very large, measuring nearly six inches across,” says OPM President and CEO Scott DeFelice. “The fit was perfect.”

That’s good news for the patient. The right implant means less time on the operating table, quicker recovery, and reduced possibility of infection. Hospitals benefit as well—typical operating room rates run upwards of $60 per minute, so pressure is high to manage the costs of patient care. Says DeFelice, “The new medical paradigm is about improving outcomes while reducing costs. That’s what additive manufacturing technology helps us accomplish.”

A contributor to this latest advancement in healthcare is the OsteoFab technology, OPM’s brand for additively manufactured medical and implant parts produced from PEKK material. PEKK (Poly-Ether-Ketone-Ketone) is DeFelice’s favorite molecule, and is a high-performance thermoplastic with many exceptional properties (see Sidebar, “A Peek at PEKK” below).

The plastic has a number of mechanical and thermal qualities that make it highly suitable for cranial reconstruction. It has a density and stiffness similar to bone, is lighter than traditional implant materials such as titanium and stainless steel, is chemically inert and is radiolucent so as not to interfere with diagnostic imaging equipment. Perhaps its most exciting attribute is bone’s affinity to the material. “PEKK as a molecule is unique,” says DeFelice. “Based on research studies, it is osteoconductive, meaning bone cells will grow onto it, unlike some other materials.”

Read the rest: http://www.mdtmag.com/articles/2013/11/first-510k-clearance-customized-3d-printed-polymeric-cranial-implants#.UrxzPGRDuSd

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