Orthopaedic implant manufacturer Extremity Medical (Parsippany, New Jersey / USA; www.extremitymedical.com) has received clearance from the US Food & Drug Administration (FDA) for its “HammerFiX” IP fusion system made of “Zeniva” polyetheretherketone (PEEK) resin from Solvay Specialty Polymers (Alpharetta, Georgia / USA; www.solvayspecialtypolymers.com) – see Plasteurope.com of 06.08.2012.

The material is part of Solvay’s line of “Solviva” biomaterials and has a modulus very close to that of bone in addition to high toughness and fatigue resistance. The company said the FDA clearance was based in part on its master access file for the material.

Jamy Gannoe, Extremity Medical’s president and co-founder, said the “HammerFiX” implant is the first cannulated (with a passage through its interior length for wire or thread) hammertoe device made of the non-resorbable polymer PEEK in the US. It is used for the fixation of osteotomies (bone divisions) and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

The implant is machined from 6-mm-diameter “Zeniva” PEEK rod stock and has been designed for stability and maintenance of the correction. The elasticity of the material aids in the delivery of the implant and, as it is also radiolucent, it enables the surgeon to better visualise the fusion site through x-ray without the shadows and opacity of titanium, the companies said.