News from AAOS: FDA Clears MedShape’s Morphix SP Suture Anchor

Just one month after it got the regulatory OK for its ACL reconstruction device, Atlanta, Ga.-based MedShape Inc. has 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.

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. According to MedShape, what differentiates PEEK Scoria from other porous polymer materials is that it uses a proprietary processing method that seamlessly connects a porous surface to a solid base.

This seamless structure reportedly 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 material was developed by a group of scientists and engineers at the Georgia Institute of Technology (Georgia Tech) through a grant from Solvay, which provides high-performance polymer technology. The Scoria surface features 65 percent porosity, a 300 micron average pore size and 99 percent interconnectivity.

“The preliminary data demonstrate bony ingrowth into the porous PEEK Scoria network,” said Professor Robert E. Guldberg, Ph.D., director of the Parker H. Petit Institute for Bioengineering and Bioscience at Georgia Tech. “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.”

Guldberg is an expert in biomaterials and device osseointegration.

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 the 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, Ph.D., professor of mechanical engineering and materials science at Georgia Tech 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.

MedShape makes surgical products for sports medicine, joint fusion, and musculoskeletal trauma.

MedShape will showcase Morphix SP and PEEK Scoria during this week’s American Academy of Orthopaedic Surgeons (AAOS) annual meeting (March 11-15) in New Orleans, La. (Booth 1135).