FDA approves first porous PEEK–based medical device


This week, MedShape Inc. (Atlanta) received US FDA 510(k) clearance for its Morphix SP Suture Anchor, which features the company's new Scoria technology, a polyetheretherketone (PEEK) material manufactured with micrometer-scale surface porosity and based on Zeniva PEEK resin from Solvay Specialty Polymers (Atlanta). MedShape reportedly is the first company to develop and clear through FDA a device containing porous PEEK.

Although studies have shown the benefits of adding porosity to biomaterials to support tissue ingrowth around an implant, the use of porous polymers has been limited in orthopaedic load-bearing applications because of a loss in mechanical properties.

PEEK Scoria uses a proprietary processing method that seamlessly connects a porous surface to a solid base. This structure maintains a shear strength twice that of trabecular bone; the overall material has mechanical strength, stiffness, and fatigue resistance in line with solid PEEK and greater than some implantable porous metals. The Scoria surface features 65% porosity, a 300 micron average pore size, and 99% interconnectivity.
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