Sam Brusco, Associate Editor05.16.23
Spinal medical device firm Wayport Orthopedics has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Waypoint GPS, a smart bone awl used during pedicle screw pilot hole drilling.
Waypoint GPS is a “Smart Gear Shift” that mimics a standard bone awl and gives additional information via visual feedback. It uses color-sensing tech developed by Waypoint that’s displayed wirelessly to an app-based operating system in real-time.
According to the company, during an in-vivo study the Waypoint GPS demonstrated 100% operator interpretation cancellous, cortical, and breach. The device could boost surgeon confidence in pilot hole drilling, while also potentially removing the need for harmful ionizing radiation for all those in the operating room.
The system was indicated for use in both open and percutaneous (MIS) spine surgeries.
Dr. Andrew Cappuccino, an orthopedic spine surgeon, told the press, "The Waypoint GPS is a simple instrument that can ensure safety within the pedicle for the placement of pedicle screws. I believe that the integration of the Waypoint GPS helps to lower radiation exposure and save time in the accurate placement of pedicle screws."
Jeffrey F. O'Donnell, Jr., president and CEO of Waypoint Orthopedics, said, "We are proud to announce the FDAs 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. As a Runway Healthcare portfolio company, we will look to transfer Waypoint Orthopedics to an existing commercial entity for wide-scale commercialization."
Dr. Stephen Banco, an orthopedic spine surgeon and co-founder of Waypoint Orthopedics, added, "The Waypoint GPS provides surgeons real-time feedback and confidence as they cannulate pedicles with incredibly simple and easy-to-use technology. I look forward to utilizing the Waypoint GPS in all of my instrumented fusions moving forward as an additional layer of safety and reliability."
Waypoint GPS is a “Smart Gear Shift” that mimics a standard bone awl and gives additional information via visual feedback. It uses color-sensing tech developed by Waypoint that’s displayed wirelessly to an app-based operating system in real-time.
According to the company, during an in-vivo study the Waypoint GPS demonstrated 100% operator interpretation cancellous, cortical, and breach. The device could boost surgeon confidence in pilot hole drilling, while also potentially removing the need for harmful ionizing radiation for all those in the operating room.
The system was indicated for use in both open and percutaneous (MIS) spine surgeries.
Dr. Andrew Cappuccino, an orthopedic spine surgeon, told the press, "The Waypoint GPS is a simple instrument that can ensure safety within the pedicle for the placement of pedicle screws. I believe that the integration of the Waypoint GPS helps to lower radiation exposure and save time in the accurate placement of pedicle screws."
Jeffrey F. O'Donnell, Jr., president and CEO of Waypoint Orthopedics, said, "We are proud to announce the FDAs 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. As a Runway Healthcare portfolio company, we will look to transfer Waypoint Orthopedics to an existing commercial entity for wide-scale commercialization."
Dr. Stephen Banco, an orthopedic spine surgeon and co-founder of Waypoint Orthopedics, added, "The Waypoint GPS provides surgeons real-time feedback and confidence as they cannulate pedicles with incredibly simple and easy-to-use technology. I look forward to utilizing the Waypoint GPS in all of my instrumented fusions moving forward as an additional layer of safety and reliability."