X-Bolt Orthopedics Gains 510(k) for Pro-X1 Trochanteric Nail

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.”

Source: X-Bolt