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Reimbursement / Regulatory

OrthoXel Gains FDA Clearance for Apex Femoral Nail -

OrthoXel received FDA 510(k) clearance to market the Apex Femoral Nailing System. Launch is slated for 2019. This follows the regulatory clearance and first clinical use of the company's first product, a tibial nail, in 1Q18. The universal nail features anatomic nail curvature and can be implanted from antegrade or retrograde orientations. Multiple-trajectory locking options include OrthoXel's exclusive micromotion for controlled axial movement with torsional stability that promotes callus formation. As needed, a locking endcap simultaneously locks all screws. (OrthoXel, 9/26/18)