OrthoXel Orthopaedic Trauma Device Company Announce CE Mark Clearance following FDA 510(k) for new Apex Femoral Nailing System
OrthoXel is a specialist orthopaedic trauma company, using innovative engineering design to evolve
truly next generation fracture fixation devices. OrthoXel is delighted to announce that following
United States FDA 510k and CE mark clearance for the Apex Tibial Nailing System, the new Apex
Femoral Nailing System has been granted European CE Mark, following the FDA 510(k) earlier in the
year.
The Apex Femoral Nailing System has the potential to be implanted by the surgeon in antegrade (at
the hip) and retrograde (at the knee) as a universal nail for left and right legs, dramatically reducing
hospital inventory. Like the Apex Tibial Nailing System, the Apex Femoral Nailing System has the
OrthoXel patented micromotion locking to stimulate bone callus formation.
The new Apex Femoral Nailing System was showcased at the Orthopaedic Trauma Association meeting
in Orlando, Florida in October and will be presented in the UK at the Orthopaedic Trauma Society
annual meeting in Burton-on-Trent January 10-11th 2019.
The Apex Femoral Nailing System
The Apex Femoral Nailing System features a modern anatomic nail curvature in a universal nail that
can be surgically implanted from antegrade or retrograde orientations with a dedicated
instrumentation kit. The system offers a comprehensive suite of versatile multiple-trajectory locking
options including patented OrthoXel? micromotion for controlled axial movement with exceptional
torsional stability to promote callus formation. Additional locking options include recon and rigid
interlocking for unstable proximal femoral fractures.
The unique Apex Femoral Nail locking options provide ultimate flexibility and control for the surgeon
to choose the right fixation for each patient. In addition to patented gliding micromotion, the Apex
system offers an innovative locking endcap that can simultaneously lock multiple bone screws for
added stability when needed
? Proximal Micromotion: Up to two mediolateral bone screws and one recon bone screw provide
torsional stability with patented controlled axial micromotion.
? Proximal Recon Rigid Locking: Up to two mediolateral bone screws and two recon bone screws
provide rigid locking, with an optional locking endcap.
? Proximal Rigid Interlocking: Up to two mediolateral bone screws, one recon bone screw, and
one interlocking bone screw provide rigid locking. The optional addition of the locking endcap
simultaneously locks all four screws when needed.
Pat O?Connor Co-Founder & CEO, OrthoXel ? ?With this latest
approval and ongoing clinical studies, OrthoXel is positioned to
target the European and US markets throughout 2019 with
products that we believe are a considerable advancement on
predicate devices on the market. This is an exciting time for
OrthoXel as we transition from R&D and proof of concept into
commercialization of our unique devices.?
Charles Daly Co-Founder & Chief Technical Officer, OrthoXel ? ?OrthoXel is delighted to receive
European CE Mark for the Apex Femoral Nailing System for the
specific treatment of a wide range of femoral fractures. We now
have full regulatory approval for both our tibial and femoral
nailing platforms and will focus on generating clinical case
studies in order to be market ready for 2019. Our incredible
engineering and design team in Cork has really strived to
achieve truly next generation intramedullary nails that are
packed with unique features and benefits for the surgeon and patient alike. We strongly recommend
anyone that wants more detailed product information to visit our new website at www.orthoxel.com.?
About OrthoXel
Founded in 2014, and partially funded under the Enterprise Ireland, High Potential Start-Up (HPSU)
fund. OrthoXel is a specialist orthopaedic trauma device company, using innovative engineering design
to evolve truly next generation fracture fixation devices.
OrthoXel is committed to patient-focused fracture care, offering surgeon-designed devices and an
innovative approach to clinical evaluation, from initial concept designs through to full product launch.
-ENDS ?
For more information about the technical specification and advanced locking options of the Apex
Femoral and the Apex Tibial Nailing Systems visit: www.orthoxel.com/product
Press Contact: Alanna Carty Global Marketing Manager alanna.carty@orthoxel.com T