Waypoint Orthopedics submits FDA 510(k) application for Waypoint GPS system

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Waypoint GPS (Waypoint Orthopedics)

Waypoint Orthopedics recently announced the submission of a US Food and Drug Administration (FDA) 510(k) application for its Waypoint GPS—a bone awl for use during pedicle screw pilot hole drilling.

The system is designed to provide the surgeon visual feedback that indicates a change in colour at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The Waypoint GPS is indicated for use in both open and percutaneous minimally invasive surgical approaches to the spine.

According to the company, Waypoint GPS looks, feels, and acts like a standard bone awl, while providing the operator with additional information via visual feedback. It utilises proprietary colour-sensing technology displayed wirelessly to an app-based operating system in real-time—potentially making vertebral fixation safer and more efficient for everyone in the operating room.

Waypoint Orthopedics’ president and CEO, Jeffrey O’Donnell Jr, said: “The Waypoint Orthopedics team has worked tirelessly over the last 18 months to develop and test the Waypoint GPS, in anticipation of this submission. I am incredibly proud of all the hard work.

“We are excited to work with the FDA in bringing this much-needed tool to the operating room, enhancing the surgeon’s confidence during the cannulation of each pedicle, while potentially reducing the amount of ionising radiation during a case. We believe in surgeon designed products, and have had tremendous input and guidance from our world-class surgeon advisory board throughout this process.”


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