FDA Clears Extremity Medical’s HammerFiX™ IP Fusion Device

Extremity Medical, LLC tells us it has received U.S. FDA 510(k) clearance for the HammerFiX™ for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

Background

We’ve covered news of Extremity Medical before, including the FDA clearance of its CarpalFix™ hand and wrist fusion system. Extremity Medical is an orthopedic device company which currently has nine products released globally including specialized fixation and advanced arthroplasty systems for the distal upper and lower extremities.

The HammerFiX™ IP Fusion Device has been designed for stability and maintenance of the surgical correction of hammertoe, claw toe, and mallet toe. The inherent elasticity of PEEK is claimed by the company to aid in the delivery of the implant in the phalanx, and opposing threads on the screw and barbed segments facilitate generation of extra compression across the joint.

In addition, the implant’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. PEEK is also radiolucent, which enables the surgeon to better visualize the fusion site. HammerFiX™ is available in three sizes to accommodate size variations of the phalanges.

The HammerFiX™ Device has officially been launched in the U.S. on April 2nd.

Company comments

Jamy Gannoe, President and Co-Founder of Extremity Medical commented, “The HammerFiX™ implant is the first cannulated hammertoe device made of the non-resorbable polymer PEEK in the U.S. PEEK has a modulus of elasticity (stiffness) that very closely mimics that of cortical bone plus excellent toughness and fatigue resistance. This has enabled us to develop a next-generation hammertoe fixation product that is differentiated among our competition in terms of material and design.”

Source: Extremity Medical, LLC., PR Newswire

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