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OrthoXel announced FDA 510(k) clearance of its Apex Femoral Nailing System. According to a company press release, the system provides multiple-trajectory locking options, including OrthoXel micromotion for controlled axial movement with torsional stability. For unstable proximal femoral fractures, additional locking options are included.
The Apex Femoral Nailing System can be implanted from antegrade or retrograde orientations with a dedicated instrumentation kit and features an anatomic nail curvature in a universal nail.
According to the release, the options of the Apex Femoral Nailing System provide surgeons more flexibility and control in choosing the right fixation for each patient. The system also has a locking endcap that can simultaneously lock multiple bone screws when needed. According to the release, locking options include micromotion locking, recon rigid locking and rigid interlocking.
“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,” Pat O’Connor, OrthoXel co-founder and CEO said in the release.
Reference:
www.orthoxel.com
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