OrthoXel™ Evolving Fracture Fixation Announce FDA 510(k) Clearance for New Apex Femoral Nailing System

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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 the new Apex Femoral Nailing System has been granted US FDA 510(k) clearance, following regulatory clearances and first clinical implantations of the Apex Tibial Nailing System earlier this year.

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.

  • – Micromotion Locking: Up to two mediolateral bone screws and one recon bone screw provide torsional stability with patented controlled axial micromotion.
  • – Recon Rigid Locking: Up to two mediolateral bone screws and two recon bone screws provide rigid locking, with an optional all screw locking endcap.
  • – 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.

The OrthoXel™ business focus is on developing the commercial market in the United States for both the Apex Tibial and Femoral Nailing Systems as well as identifying select markets outside the US (OUS). OrthoXel™ is now working to identify potential commercial partners.

Pat O’Connor Co-Founder & CEO, OrthoXel™ – “While we recognise the challenge of entering markets dominated by large multinationals, OrthoXel™ is confident that the unique locking options and advantageous biomechanics of both our Apex Femoral and our Apex Tibial Nailing Systems confers real market advantage. Our products really should be the devices of choice for orthopaedic trauma care.”

Charles Daly Co-Founder & Chief Technical Officer, OrthoXel™ – “OrthoXel™ is delighted to receive US FDA 510(k) clearance for the Apex Femoral Nailing System for the specific treatment of a wide range of femoral fractures. We will now be focusing on generating clinical case studies and will be market ready in 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.

Source: https://www.prnewswire.com/news-releases/orthoxel-evolving-fracture-fixation-announce-fda-510k-clearance-for-new-apex-femoral-nailing-system-300719155.html

For Further Information

More on the orthopedic trauma market in the U.S. can be found in a series of reports published by iData entitled the U.S. Market Report Suite for Orthopedic Trauma Devices. This report covers the following market segments:  plate and screw, bioabsorbable trauma fixation, intramedullary nails, cannulated screws, intramedullary hip nails, conventional hip fixation, bone staples, bone pins, external fixation and bone growth stimulators.

The iData series on the market for orthopedic trauma covers the U.S. and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about orthopedic trauma device market data or procedure data, register online or email us at info@idataresearch.net for an U.S. Market Report Suite for Orthopedic Trauma Devices brochure and synopsis.

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