FDA 510(k) clearance for Y-Wire 2

Cooper City, Florida – Officials from iReach/ SafeWire LLC, a medical device company focused on the design and development of devices for minimally invasive spine surgery, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Y-Wire 2 orthopedic guidewire with additional claims.

The Y-Wire 2 is an orthopedic guidewire with a distinctive split tip that is designed to prevent inadvertent advancement of the wire through bone. Upon exiting its delivery mechanism, the Y-Wire 2's distal tips deploy to prevent further advancement.

Wyatt Geist, CEO of Safewire said, "Safewire is committed to the advancement of minimally invasive instrumentation for spine surgeons and their patients. FDA clearance of the Y-Wire is a significant milestone, and we are excited to provide the surgical community with a guidewire designed to mitigate inadvertent advancement during minimally invasive spinal surgery. "

Joseph Zavatsky, M.D., stated, "The Y-Wire 2 provides a solution to an ongoing issue in minimally invasive spine surgery. More importantly, it may also facilitate a return to bi-cortical fixation in the sacrum. Bi-cortical fixation in the sacrum has been the standard in open spinal surgery, but its adoption in minimally invasive surgery has been hampered by the issue of guidewire advancement."

The Y-Wire 2 was designed for compatibility with a wide variety of delivery systems such as fluoroscopy, robotics, and image guidance making adoption of this innovative technology less disruptive to hospitals with established instrumentation providers.

Source: SafeWire