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MedShape receives 510(k) clearance for suture anchor

The FDA issued 510(k) clearance to MedShape Inc. for its Morphix SP Suture Anchor.

According to a company press release, the device features the company’s Scoria technology, a polyetheretherketone (PEEK) material manufactured with interconnected micrometer scale surface porosity and based on Zeniva PEEK resin from Solvay Specialty Polymers. 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 pullout strength that is maintained under repeated loading conditions. Morphix SP has an initial low profile shape to facilitate insertion and a final expanded shape to securely lock into bone.

“The clearance of the Morphix SP device represents an important milestones 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,” Ken Gall, chief technology officer at MedShape and professor of mechanical engineering and materials science at the Georgia Institute of Technology, stated in the release.