Waypoint Orthopedics receives FDA 510(k) clearance of smart bone awl for pedicle screws
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Key takeaways:
- Waypoint Orthopedics Inc. has announced FDA 510(k) clearance of the Waypoint GPS.
- The smart bone awl is indicated for pedicle screw drilling during open and percutaneous minimally invasive spine surgery.
Waypoint Orthopedics Inc. has announced FDA 510(k) clearance of the Waypoint GPS, a smart bone awl designed to drill pilot holes for pedicle screws, according to a press release.
The system is indicated for use in open and percutaneous minimally invasive spine surgeries, according to the release.
“We are proud to announce the 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,” Jeffrey F. O'Donnell Jr., president and CEO of Waypoint Orthopedics, said in the release. “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,” O’Donnell added.
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