FDA Clears Extremity Medical’s HammerFix Fusion Device

Extremity Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its HammerFiX, designed for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

The HammerFiX device officially launched in the United States on April 2 and is available in three sizes to accommodate size variations of the phalanges.

The HammerFiX IP fusion device was designed for stability and maintenance of the correction. The inherent elasticity of polyetheretherketone (PEEK) aids in the delivery of the implant in the phalanx. PEEK also is radiolucent, which enables the surgeon to better visualize the fusion site.

Opposing threads on the screw and barbed segments allow the ability to generate extra compression across the joint.

The IP fusion device’s design provides an option to temporarily pin the corrected phalanx to the metatarsal with a guidewire in order to minimize metatarsophalangeal joint subluxation during healing, according to the company.

Extremity Medical President and co-founder Jamy Gannoe said the HammerFiX implant is the first cannulated hammertoe device made of the non-resorbable polymer PEEK in the United States.

“PEEK has a modulus of elasticity (stiffness) that very closely mimics that of cortical bone plus excellent toughness and fatigue resistance,” he said. “This has enabled us to develop a next-generation hammertoe fixation product that is differentiated among our competition in terms of material and design.”