First FDA Clearance for a Porous PEEK Implant

Shape Memory Orthopaedic device company MedShape, Inc., has received U.S. FDA 510(k) clearance for its Morphix® SP Suture Anchor. MedShape is the first company to develop and clear through the FDA a device containing porous PEEK , which it hopes will bring the advantages that this characteristic has delivered to metal implants in recent years, to polymer-based devices.

Background

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 polyetheretherketone (PEEK). The company’s Morphix SP shoulder anchor features its new Scoria™ technology, a 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 ingrowth around the implant. 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. PEEK Scoria sets itself apart from other porous polymer materials by using 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.

The Morphix SP 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.

Expert comment

Professor Bob Guldberg, director of the Parker H. Petit Institute for Bioengineering and Bioscience at the Georgia Institute of Technology, and a world-renowned expert in biomaterials and device osseointegration has recently studied bony ingrowth in PEEK Scoria. His results 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.”

Company comment

“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.”

You can find more, here, including a video… you might want to turn the sound down though.

Source: MedShape, Inc., PR Newswire

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