OrthoXel has won FDA 510(k) clearance for its new Apex Femoral Nailing System.

The nailing system features a modern anatomical nail curvature in a universal nail that is able to be surgically implanted from antegrade or retrograde orientations with a special instrumentation kit. The OrthoXel system also features a comprehensive suite of versatile multiple-trajectory locking options like the company’s micromotion that is used for controlled axial movement with torsional stability to promote callus formation. It also offers additional locking options like recon and rigid interlocking for fixing unstable proximal femoral fractures.

“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. Our products really should be the devices of choose for orthopedic trauma care,” Pat O’Conner, cofounder and CEO of OrthoXel, said in a press release.

Apex Femoral Nailing System gives surgeons flexibility and control to choose the right fixation system for different patients. The system features a locking endcap that can lock multiple bone screws for stability. The micromotion locking offers up to two mediolateral bone screws and one recon bone screw to give torsional stability with controlled axial micromotion. The recon rigid locking stabilizes up to two mediolateral bone screws and two recon bone screws to give rigid locking with an optional all screw locking endocarp. Rigid interlocking stabilizes up to two mediolateral bone screws, one recon bone screw and one interlocking bone screw. A locking endcap can lock all four screws if needed.

“OrthoXel is delighted to receive U.S. FDA 510(k) clearance for the Apex Femoral Nailing System for the specific treatment of a wide range of femoral fractures,” Charles Daly, cofounder and chief technology officer, said. “We 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. We strongly recommend anyone that wants more details product information to visit our new website.”