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Nextremity Solutions Unveils Foot and Ankle Staple System

September 15, 2015

Nextremity Solutions Inc., a foot and ankle implant manufacturer, recently received 510(k) clearance from the U.S. Food & Drug Administration for its Arcus staple system.

“We are excited about the recent 510(k) approval of Nextremity’s new Arcus staple system,” said Ryan Schlotterback, director of product development. “The unique design of our new staple generates excellent compression and is indicated for use throughout the foot and ankle. Our testing has shown that the Arcus staple performs better at maintaining compression over time when compared to the competition. We look forward to the first implantations later this year.”

The Arcus system is indicated for fixation of bone fractures, bone reconstruction, ligament, soft tissue and tendon, which includes fixation of bone fragments or small-bone fractures, as well as fracture management in the foot and hand. An application for CE mark is pending, company officials noted.

Rod K. Mayer, president of Nextremity Solutions, said: “I’m extremely proud of the hard work our product development team has put into this product line. By working closely with our surgeon partners, we have developed a truly unique staple that will provide for more stable fixations in foot and ankle deformity correction, as well as trauma applications and other uses. We look forward to getting this product into the marketplace.”

Warsaw, Ind.-based Nextremity Solutions is a privately held medical device company focused on procedure-ready, sterile implant systems for the correction of foot and ankle pathologies.