Extremity Medical, LLC Announces 510(k) Clearance for its HammerFiX™ IP Fusion Device

Apr 02, 2014, 15:26 ET from Extremity Medical, LLC

PARSIPPANY, N.J., April 2, 2014 /PRNewswire/ -- Extremity Medical, LLC announced that it has received 510(k) clearance for the HammerFiX. The HammerFiX device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

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."

The HammerFiX™ IP Fusion Device was designed for stability and maintenance of the correction.  The inherent elasticity of PEEK aids in the delivery of the implant in the phalanx.  Opposing threads on the screw and barbed segments allow the ability to generate 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.

Extremity Medical, LLC is an orthopedic device company specializing in the development of next generation systems addressing unmet needs. The company currently has nine products released globally including specialized fixation and advanced arthroplasty systems for the distal upper and lower extremities. The company's products are covered by an extensive portfolio of existing and pending patents.

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SOURCE Extremity Medical, LLC