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Extremity Medical, New Jersey, US, has received 510(k) clearance from the US Food & Drug Administration (FDA) for its new HammerFiX IP fusion system made of Zeniva polyetheretherketone (PEEK) resin from Solvay Specialty Polymers.
According to Solvay, its Zeniva PEEK, which forms part of its line of Solviva Biomaterials, has a modulus very close to that of bone plus excellent toughness and fatigue resistance. It explains that 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 Illinois, US.
According to Jamy Gannoe, Extremity Medical’s President and Co-Founder, the HammerFiX implant is the first cannulated hammertoe device made of the non-resorbable polymer PEEK in the US. It is used for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
“Zeniva PEEK’s exceptional properties have enabled us to develop a next-generation hammertoe fixation product that is differentiated among our competition in terms of material and design,” said Gannoe.
Solvay explains that the HammerFiX implant, machined from 6-mm-diameter Zeniva PEEK rod stock, was designed for stability and maintenance of the correction. It says the inherent elasticity of Zeniva PEEK aids in the delivery of the implant in the phalanx. The reverse helical thread pattern of the implant’s barbed segment allows for a technique which provides additional compression across the joint.
The implant is also designed to provide an option to temporarily pin the corrected phalanx to the metatarsal with a guide wire in order to minimise metatarsophalangeal joint subluxation during healing. Zeniva PEEK is radiolucent which enables the surgeon to better visualise the fusion site via x-ray without the shadows and opacity of titanium.
The HammerFiX implant comes in three sizes – 2.8 mm, 3.4 mm, and 4 mm – to accommodate the size variation of the phalanges.
“This application demonstrates the superior toughness and ductility of Zeniva PEEK over the competition,” said Shawn Shorrock, Global Director of Regulatory Affairs for Solvay Specialty Polymers’ healthcare business. “These unique properties, plus the well-established history of biological safety for Zeniva PEEK, will continue to support its growth in the orthopedic market.”
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