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OrthoXel receives FDA clearance, CE mark for tibial nail system
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OrthoXel announced it has received FDA 510(k) clearance and CE mark approval for the Apex tibial nailing system.
According to a company press release, the system offers surgeons the greatest range of locking options of any intramedullary nail. The micromotion locking mode of the system reportedly provides controlled axial movement with torsional stability, which is ideal for callus formation. The system reportedly is the first to implement controlled micromotion in an intramedullary nailing platform. The reusable implantation kit offers quick and reliable nail implantation in any locking mode.
“We are excited that the approvals in the major markets in the [United Statues] U.S. and [European Union] E.U. opens the opportunity for OrthoXel to get out devices in the hands of orthopedic surgeons,” Pat O’Connor, CEO of OrthoXel, said in the release. “We look forward to identifying the best route to market for the product portfolio and rolling out the technology in the coming months.”
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