OrthoXel was granted approval under the CE Mark for the Apex Tibial Nailing System, which is now cleared for marketing the U.S. and Europe.
The universal nail can be implanted via an antegrade or retrograde approach, and features micromotion locking to stimulate the formation of bone callus. Additional locking options include recon and rigid interlocking for unstable proximal femoral fractures. A locking encap can simultaneously lock multiple screws for additional stability.
With regulatory clearances in hand, OrthoXel will now focus on clinical case studies in support of 2019 launch for Apex Femoral and Apex Tibial nails.