MedShape, Inc., today announced the company received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Morphix® SP Suture Anchor. The 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.
While porous metals have found their way into medical devices, MedShape is the first company to develop and clear through the FDA a device containing porous PEEK. MedShape will showcase Morphix SP and PEEK Scoria this month at the upcoming American Academy of Orthopaedic Surgeons (AAOS) Annual Conference in New Orleans (Booth #1135).
Previous studies have reported the benefits of adding porosity to biomaterials to help support tissue in-growth around the implant.1 However, to date, the use of porous polymers has been limited in orthopaedic 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, a world leader in high-performance polymer technology. The Scoria surface features 65% porosity, a 300 micron average pore size and 99% interconnectivity.
Professor Bob Guldberg is the director of the Parker H. Petit Institute for Bioengineering and Bioscience at the Georgia Institute of Technology, and is a world-renowned expert in biomaterials and device osseointegration. Professor Guldberg has recently studied bony ingrowth in PEEK Scoria and results of his work will be presented at the Orthopaedic Research Society Annual Meeting following AAOS in March. According to Guldberg, "The preliminary data demonstrate bony ingrowth into the porous PEEK Scoria network. Future studies will include a fundamental understanding of the extent of osseointegration and soft tissue attachment and the impact of the release of biologic agents from the porous network."
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 also Chief Technology Officer 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.
For more information on PEEK Scoria and Morphix SP, please visit www.medshape.com/our-science.html and http://www.medshape.com/our-products/morphix.html.