Sam Brusco03.07.23
X-Bolt, an emerging orthopedic innovator, has earned 510(k) clearance from the U.S. Food and Drug Administration (FDA) fdor its Pro-X1 trochanteric nail hip fracture solution.
Pro-X1 will be X-Bolt’s flagship launch in the U.S.
"We are thrilled to receive FDA clearance for the Pro-X1 Trochanteric Nail," Brian Thornes, X-Bolt's founder and inventor of the globally recognized product, TightRope, told the press. "Pro-X1 builds off of the foundational expanding bolt design, clinically proven with a 0.8% cut-out rate in the largest ever hip fracture randomized controlled trial. We are proud to offer this innovative device to orthopedic trauma patients and are confident that it will make a significant impact in the lives of those in need."
The Pro-X1 trochanteric nail has a titanium nail construct with a reversibly expanding bolt, rather than a typical lag screw. The expanding bolt, according to the company, allows stronger anchorage and rotational stability of the femoral head. The system’s instrumentation includes the company’s Metro Jig, a curved jig with flexi-drive coupling to streamline operative technique.
"We are committed to developing orthopedic devices at the intersection of the best applications of our patented expanding bolt technology and the most demanding needs in orthopedic trauma," said Thornes.
Pro-X1 will be X-Bolt’s flagship launch in the U.S.
"We are thrilled to receive FDA clearance for the Pro-X1 Trochanteric Nail," Brian Thornes, X-Bolt's founder and inventor of the globally recognized product, TightRope, told the press. "Pro-X1 builds off of the foundational expanding bolt design, clinically proven with a 0.8% cut-out rate in the largest ever hip fracture randomized controlled trial. We are proud to offer this innovative device to orthopedic trauma patients and are confident that it will make a significant impact in the lives of those in need."
The Pro-X1 trochanteric nail has a titanium nail construct with a reversibly expanding bolt, rather than a typical lag screw. The expanding bolt, according to the company, allows stronger anchorage and rotational stability of the femoral head. The system’s instrumentation includes the company’s Metro Jig, a curved jig with flexi-drive coupling to streamline operative technique.
"We are committed to developing orthopedic devices at the intersection of the best applications of our patented expanding bolt technology and the most demanding needs in orthopedic trauma," said Thornes.