ROSEMONT, Ill., June 11, 2014 –Extremity Medical LLC, Parsippany, N.J., an entrepreneurial-based manufacturer of orthopedic implants for the distal extremities, has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its new HammerFiX™IP fusion system made of Zeniva® polyetheretherketone (PEEK) resin from Solvay Specialty Polymers. Zeniva® PEEK – part of Solvay’s line of Solviva® Biomaterials – has a modulus very close to that of bone plus excellent toughness and fatigue resistance. The FDA clearance was based in part on Solvay’s well-developed master access file for Zeniva® PEEK. Solvay made the announcement at the 10th Annual Orthopedic Manufacturing & Technology (OMTEC) exposition June 11-12 in Rosemont, Ill.
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