FOR IMMEDIATE RELEASE:
October 11th 2016
HammerTech Fixation System – FDA Cleared
We are pleased to announce the HammerTech Fixation System as a new addition to the Fusion Orthopedics product offering. FDA 510(k) clearance was issued October 11th, 2016. The assigned FDA 510(k) # for the HammerTech Fixation System is K161449.
The HammerTech device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
The HammerTech Fixation System implant is a polyetheretherketone (PEEK) threaded bone implant intended for fixation of the proximal interphalangeal (PIP) joint of the lesser toes. The PIP implant is comprised of two ends of a single, solid member. Each end slides into the prepared canal of the bone to be fused. The device is a straight cannulated design offered in four different sizes to address the wide variation of patient anatomy.