OrthoXel Orthopaedic Trauma Device Co. Receives CE Mark Clearance for Apex Femoral Nailing System

European regulators have granted CE Mark clerance to OrthoXel’s Apex Femoral Nailing System. The product received U.S. Food and Drug Administration 510(k) clearance in 2018.
 
The Apex Femoral Nailing System is the only femur nailing system on the market to feature micromotion fixation along with new trajectories of advanced locking options to offer unparalleled implant flexibility, resulting in optimum fixation for a wide range of femur fracture types, according to the company.
 
The Apex Femoral Nailing System has the potential to be implanted by the surgeon in antegrade (at the hip) and retrograde (at the knee) as a universal nail for left and right legs, dramatically reducing hospital inventory. Like the Apex Tibial Nailing System, the Apex Femoral Nailing System has the OrthoXel patented micromotion locking to stimulate bone callus formation.

The system was unveiled last week in the United Kingdom  at the Orthopaedic Trauma Society annual meeting in Burton-on-Trent.

The 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 suite of 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. 

Pat O’Connor co-founder and CEO of OrthoXel, said, “With this latest approval and ongoing clinical studies, OrthoXel is positioned to target the European and U.S. markets throughout 2019 with products that we believe are a considerable advancement on predicate devices on the market. This is an exciting time for OrthoXel as we transition from R&D and proof of concept into commercialization of our unique devices.”
 
The Apex Femoral Nail locking options provide ultimate flexibility and control for the surgeon to choose the right fixation for each patient. In addition to patented gliding micromotion, the Apex system offers a locking endcap that can simultaneously lock multiple bone screws for added stability when needed.

• Proximal Micromotion: Up to two mediolateral bone screws and one recon bone screw provide torsional stability with patented controlled axial micromotion.
• Proximal Recon Rigid Locking: Up to two mediolateral bone screws and two recon bone screws provide rigid locking, with an optional locking endcap.
• Proximal Rigid Interlocking: Up to two mediolateral bone screws, one recon bone screw, and one interlocking bone screw provide rigid locking. The optional addition of the locking endcap simultaneously locks all four screws when needed.

Charles Daly co-founder and chief technical officer of OrthoXel, said, “OrthoXel is delighted to receive European CE Mark for the Apex Femoral Nailing System for the specific treatment of a wide range of femoral fractures. We now have full regulatory approval for both our tibial and femoral nailing platforms and will focus on generating clinical case studies in order to be market ready for 2019. Our engineering and design team in Cork has really strived to achieve next-generation intramedullary nails that are packed with unique features and benefits for the surgeon and patient alike.” 
 
Founded in 2014, and partially funded under the Enterprise Ireland High Potential Start-Up (HPSU) fund, OrthoXel is a specialist orthopaedic trauma device company using engineering design to evolve next-generation fracture fixation devices. OrthoXel is committed to patient-focused fracture care, offering surgeon-designed devices and an innovative approach to clinical evaluation, from initial concept designs through to full product launch.