Waypoint GPS Gains FDA 510(k) Clearance

Waypoint Orthopedics’ Waypoint GPS, a smart bone awl for use during pedicle screw pilot hole drilling, received 510(k) marketing clearance from FDA.

The Waypoint GPS is a Smart Gear Shift that 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. Waypoint GPS showed 100% operator interpretation cancellous, cortical and breach during an in vivo study. The device has the potential to increase surgeon confidence in pilot hole drilling while also potentially obviating the need for radiation for all parties in the operating room. The system is indicated for use in both open and percutaneous surgical approaches to the spine.

Jeffrey F. O’Donnell, Jr., President and CEO of Waypoint Orthopedics, said, “We are proud to announce FDA’s clearance of the Waypoint GPS. We firmly believe this product will become an everyday instrument for spine surgeons saving time, increasing confidence in screw placement, and adding layers of safety to every case regardless of approach. The Waypoint GPS has been designed to integrate easily into any workflow, all while providing the surgical team with information clearly and intuitively.”

Source: Waypoint Orthopedics