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FDA issues 510(k) clearance for Extremity Medical’s HammerFiX IP fusion device

The FDA granted 510(k) clearance to Extremity Medical LLC for its HammerFiX IP fusion device. The device is used for osteotomy fixation and reconstruction of the lesser toes after hammertoe, claw toe and mallet toe fixation.

Designed for fixation stability and maintenance, the device maintains elasticity while maintaining extra compression across the joint. The implant can temporarily pin the corrected phalanx to the metatarsal with a guide wire, minimizing metatarsophalangeal joint subluxation during healing.

“The HammerFiX implant is the first cannulated hammertoe device made of non-resorbable polymer PEEK in the United States,” Jamy Gannoe, president and co-founder of Extremity Medical, stated in a company press release. “PEEK has a modulus of elasticity (stiffness) that 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.”