FDA clearance for porous PEEK suture anchor

FDA clearance for porous PEEK suture anchor

MedShape Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Morphix SP Suture Anchor.

March 10, 2014
Manufacturing Group
Contract Manufacturing Design/Engineering Devices/Implants/Equipment Industry/Regulations Materials

The Morphix SP Suture Anchor device features the company's new Scoria technology, a polyetheretherketone (PEEK) material manufactured with interconnected micrometer scale surface porosity and based on Zeniva PEEK resin from Solvay Specialty Polymers.

Previous studies have reported the benefits of adding porosity to biomaterials to help support tissue in-growth around the implant. However, to date, the use of porous polymers has been limited in orthopedic load-bearing applications due to the loss in mechanical properties typically associated with introducing porosity in a material. Unlike other porous polymer materials, PEEK Scoria uses a proprietary processing method that seamlessly connects a porous surface to a solid base. This seamless structure maintains a shear strength twice that of trabecular bone while the overall material has mechanical strength, stiffness, and fatigue resistance in line with solid PEEK and greater than some implantable porous metals. This unique material was developed by a group of scientists and engineers at the Georgia Institute of Technology through a grant from Solvay. The Scoria surface features 65% porosity, a 300-micron average pore size and 99% interconnectivity.

Morphix SP is the first product in MedShape's portfolio to leverage the Scoria technology. The suture anchor features a similar expandable wing design and offers the same performance benefits as MedShape's original Morphix anchor, including excellent pullout strength that is maintained even under repeated loading conditions. Using MedShape's shape memory technology, Morphix SP has an initial low profile shape to facilitate easy insertion and a final expanded shape to securely lock into bone.

"PEEK Scoria is an exciting new technology platform for MedShape that is backed by extensive university biomaterials research," said Ken Gall, PhD, professor of mechanical engineering and materials science at the Georgia Institute of Technology and CTO at MedShape. "The clearance of the Morphix SP device represents an important milestone for MedShape, reflecting the future direction of the company's growing product portfolio. Research is ongoing to create polymer devices capable of providing both immediate mechanical strength and local surface structure-mediated biological repair without the drawbacks of complete device resorption."

Solvay's Zeniva PEEK is part of the Solviva Biomaterials lineup, which is offered for use in implantable medical devices. The biomaterial boasts a modulus very close to that of bone plus excellent biocompatibility, toughness, and fatigue resistance.

Source: MedShape