Waypoint Orthopedics Announces Submission of FDA 510(k) Application

Waypoint Orthopedics

MALVERN, PA — Waypoint Orthopedics, Inc., a spinal instrumentation company, announced the company’s recent submission of an FDA 510(k) application for the Waypoint GPS™ – a smart 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 color 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 (MIS) surgical approaches to the spine.

The Waypoint GPS is a Smart Gear Shift™ that reportedly looks, feels, and acts like a standard bone awl, while providing the operator with additional information via visual feedback. It utilizes proprietary color-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.

“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,” said Jeffrey F. O’Donnell, Jr., President and CEO of Waypoint Orthopedics. “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 ionizing 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.”

Waypoint Orthopedics, a Runway Healthcare LP portfolio company, will look to transfer its technology to a commercial entity upon approval from the FDA, which is anticipated later this year.

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