X-Bolt’s Pro-X1 Trochanteric Nailing System Makes U.S. Debut

X-Bolt Orthopedics has launched its Pro-X1 Trochanteric Nailing System in the United States, conducting its first implant surgery in Florida.

The Pro-X1 system offers stronger anchorage and rotational stability in osteoporotic hip fracture fixation compared to traditional screw-based methods, according to the company. This is especially beneficial for frail, elderly patients, as the expanding bolt provides superior fixation, addressing one of the major challenges in hip fracture treatment.
 
The Pro-X1 system builds on the company’s work in hip fracture treatment. The expanding bolt design—in its first generation—was clinically proven in the largest hip fracture randomized controlled trial. It boasted the lowest-ever cut-out rate published for hip fractures at 0.8%—a breakthrough in orthopedic trauma care, where existing solutions rely heavily on screw-based fixation methods that limit stability, particularly for patients with fragile bone structures.
 
“Orthopedic trauma has seen the treatment of ankle injuries revolutionized with the TightRope suture-button, and should expect to see a similar paradigm shift now in the treatment of hip fractures with our expanding bolt and the Pro-X1 system,” said Dr. Brian Thornes, X-Bolt’s founder and previous inventor of the globally recognized TightRope. “Hip fractures affect over 200,000 patients annually in the U.S., and this will bring a much-needed advancement in patient care.”
 
The Pro-X1 Trochanteric Nailing System received U.S. Food and Drug Administration (FDA) 510(k) clearance in 2023, and the completion of this first U.S. surgery marks the beginning of a limited commercial release. X-Bolt plans to scale its operations in the coming months, deploying additional inventory and expanding its reach to more markets across the United States. Following this launch, X-Bolt will continue to innovate and broaden its product line to apply its expanding bolt technology to more orthopedic trauma indications.
 
X-Bolt is an Irish orthopedic medical device developer that provides solutions for orthopedic trauma with its patented expanding bolt technology. Founded in 2007, X-Bolt’s technology has demonstrated positive clinical results, including the lowest published cut-out rates for hip fracture. Investors in X-Bolt include BVP Partners, AIB Seed Capital, Ascentifi, Amalfi, MedTech angel group, and several Irish orthopedic surgeons.