X-Bolt received FDA 510(k) clearance to market the Pro-X1 Trochanteric Nail. The device will be X-Bolt’s flagship launch in the United States.
The Pro-X1 Trochanteric Nail features a titanium nail construct with a reversibly expanding bolt instead of a typical lag screw. The expanding bolt enables stronger anchorage and rotational stability of the femoral head. The system’s innovative instrumentation includes the patented Metro Jig, a curved jig with flexi-drive coupling, to streamline the operative technique.
The Pro-X1 Trochanteric Nailing System is intended for use in fracture fixation in the femur in adults with osteopenia or osteoporosis. The Pro-X1 Trochanteric Nailing System is indicated for use in:
Intertrochanteric and subtrochanteric fractures
Segmental fractures
Comminuted fractures
Pathological fractures
Fractures with bone loss
Pseudoarthrosis, non-union, mal-union and delayed union
Surgically created defects such as osteotomies
“We are thrilled to receive FDA clearance for the Pro-X1 Trochanteric Nail,” said Brian Thornes, X-Bolt’s founder and inventor of the globally recognized product, TightRope®. “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.”
X-Bolt received FDA 510(k) clearance to market the Pro-X1 Trochanteric Nail. The device will be X-Bolt's flagship launch in the United States.
The Pro-X1 Trochanteric Nail features a titanium nail construct with a reversibly expanding bolt instead of a typical lag screw. The expanding bolt enables stronger anchorage and rotational stability of...
X-Bolt received FDA 510(k) clearance to market the Pro-X1 Trochanteric Nail. The device will be X-Bolt’s flagship launch in the United States.
The Pro-X1 Trochanteric Nail features a titanium nail construct with a reversibly expanding bolt instead of a typical lag screw. The expanding bolt enables stronger anchorage and rotational stability of the femoral head. The system’s innovative instrumentation includes the patented Metro Jig, a curved jig with flexi-drive coupling, to streamline the operative technique.
The Pro-X1 Trochanteric Nailing System is intended for use in fracture fixation in the femur in adults with osteopenia or osteoporosis. The Pro-X1 Trochanteric Nailing System is indicated for use in:
Intertrochanteric and subtrochanteric fractures
Segmental fractures
Comminuted fractures
Pathological fractures
Fractures with bone loss
Pseudoarthrosis, non-union, mal-union and delayed union
Surgically created defects such as osteotomies
“We are thrilled to receive FDA clearance for the Pro-X1 Trochanteric Nail,” said Brian Thornes, X-Bolt’s founder and inventor of the globally recognized product, TightRope®. “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.”
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