OrthoXel’s Femoral Nail Cleared by FDA
Cork, Ireland-based OrthoXel's new femoral nailing system has been cleared by the FDA for sale in the U.S., according to a September 26, 2018 announcement by the company.
The company says its Apex Femoral Nailing System, features a "modern anatomic nail curvature in a universal nail that can be surgically implanted from antegrade or retrograde orientations with a dedicated instrumentation kit.
"The system offers a comprehensive suite of versatile multiple-trajectory locking options including patented OrthoXel micromotion for controlled axial movement with exceptional torsional stability to promote callus formation. Additional locking options include recon and rigid interlocking for unstable proximal femoral fractures."
FDA documents state the system is intended for temporary fixation and stabilization of the fractures of the femur. The nail is indicated for use in adult patients for treatment of:
- Open and closed fractures, including simple, severely comminuted, spiral, large oblique, and segmental fractures;
- Fractures involving osteopenic or osteoporotic bone;
- Fractures with bone loss:
- Pseudoarthosis, nonunion, and malunion;
- Correct osteotomy;
- Pathologic fractures and prophylactic nailing of impending pathologic fractures;
- Periprosthetic fractures;
- Closed supracondylar fractures (retrograde only) and;
- Intertrochanteric and subtrochanteric fractures (antegrade only)
It took the agency about six weeks to clear the device.
Acknowledging the company's small size, Pat O'Connor, the company's co-founder and CEO, said, "While we recognize the challenge of entering markets dominated by large multinationals, OrthoXel is confident that the unique locking options and advantageous biomechanics of both our Apex Femoral and our Apex Tibial Nailing Systems confers real market advantage."
Co-founder and Chief Technical Officer, Charles Daly, said the company will now be focusing on generating clinical case studies and will be market ready in 2019. "Our incredible engineering and design team in Cork has really strived to achieve truly next-generation intramedullary nails that are packed with unique features and benefits for the surgeon and patient alike."
OrthoXel was founded in 2014 after five years of research and development work in the Medical Engineering Design and Innovation Centre at Cork Institute of Technology. The company was supported by Enterprise Ireland, Local Enterprise Office Cork, Cork Institute of Technology, University College Cork.