MedShape Inc., Atlanta, has received FDA 510(k) clearance for its Morphix SP Suture Anchor. MedShape’s shape-memory technology enables Morphix SP to have an initial low profile shape to facilitate easy insertion, and a final expanded shape to securely lock into bone. 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.
Unlike other porous polymer materials, PEEK Scoria is made by 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.
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.
Professor Bob Guldberg, is the director of the Parker H. Petit Institute for Bioengineering and Bioscience at Georgia Institute of Technology, and is a world-renowned expert in biomaterials and device osseointegration. According to Prof. 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.”
Dr. Ken Gall is Professor of Mechanical Engineering and Materials Science at Georgia Institute of Technology and also Chief Technology Officer at MedShape. “The clearance of the Morphix SP device represents an important milestone for MedShape, ” he says, “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 provides a modulus very close to that of bone plus excellent biocompatibility, toughness, and fatigue resistance.
http://www.medshape.com/our-products/morphix.html
