Parsippany, N.J. – Extremity Medical LLC, 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. The HammerFiX implant is the first cannulated hammertoe device made of the non-resorbable polymer PEEK in the U.S., according to Jamy Gannoe, Extremity Medical’s president and co-founder. 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.
The HammerFiX implant, machined from 6mm-diameter Zeniva PEEK rod stock, was designed for stability and maintenance of the correction. 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’s design also provides an option to temporarily pin the corrected phalanx to the metatarsal with a guide wire in order to minimize metatarsophalangeal joint subluxation during healing. Zeniva PEEK is also radiolucent which enables the surgeon to better visualize the fusion site via x-ray without the shadows and opacity of titanium.
The HammerFiX implant comes in three sizes – 2.8mm, 3.4mm, and 4mm – 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.”
The manufacturing site for Zeniva PEEK and other Solviva Biomaterials in Alpharetta, Ga., is ISO 13485 registered and the relevant aspects of current Good Manufacturing Practices are also applied. Solvay’s biomaterial manufacturing processes are carefully validated and enhanced controls provide product traceability. In addition, all materials are tested in an ISO 17025 accredited lab.
In addition to Zeniva PEEK, Solvay’s Solviva Biomaterials line includes Proniva self-reinforced polyphenylene (SRP), one of the world’s stiffest and strongest unreinforced thermoplastics which offers exceptional biocompatibility and hardness; Veriva polyphenylsulfone (PPSU), which provides unsurpassed toughness combined with transparency and excellent biocompatibility; and Eviva polysulfone (PSU), which offers toughness in a strong, transparent polymer.