OrthoXel announced it received CE mark clearance for its Apex femoral nailing system.
According to a company press release, the femoral nailing system features micromotion fixation with new advanced locking options to provide implant flexibility. The micromotion reportedly provides controlled axial movement with torsional stability to promote callus formation. The system can be implanted by the surgeon in either antegrade or retrograde as a universal nail for left and right legs, which may reduce hospital inventory. The Apex femoral nailing system also offers rigid interlocking for unstable proximal femoral fractures. The system provides a locking endcap that locks multiple bone screws simultaneously for added stability when needed.
“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,” Pat O'Connor, co-founder and CEO of OrthoXel, said in the release. “This is an exciting time for OrthoXel as we transition from [research and development] R&D and proof of concept into commercialization of our unique devices.”