510k, CE Mark for OrthoXel’s Tibial Nail System

OrthoXel, an innovative new orthopedic trauma company, pioneering the use of enhanced fracture fixation to stimulate callus formation with the goal to reduce healing time, is delighted to announce that FDA 510k clearance and European CE mark approval have been granted for their Apex Tibial Nailing System. These approvals allow commercialization of the system in the US and EU markets.
 
The Apex Tibial Nailing system offers surgeons the greatest range of locking options of any intramedullary nail on the market, allowing tailored patient care with a simple and intuitive surgical procedure. The Apex system’s revolutionary micro-motion locking mode allows controlled axial movement with exceptional torsional stability, providing the ideal conditions for callus formation. Research shows that controlled small axial movements along the length of the bone help to accelerate healing, while twisting movements slow down healing.
 
The Apex system has a unique design featuring the first-ever implementation of this controlled micro-motion in an intramedullary nailing platform, all with no changes to the established evidence-based reamed insertion technique. The Apex system also provides additional locking modes so the surgeon can customize the fixation to suit the needs of the patient, including: standard cross-locking, true rigid fixation with multiple proximal screw clamping to generate a substantially rigid construct, and dynamization locking with unparalleled built-in torsional stability. The state of the art reusable implantation kit allows fast and reliable nail implantation in any locking mode.
 
No other intramedullary nail currently on the market in the US or the EU gives surgeons the freedom to choose this ideal combination of flexibility and stability for their patients.
 
Pat O’ Connor, CEO of OrthoXel, stated, “We are excited that the approvals in the major markets of the US and EU opens the opportunity for OrthoXel to get our devices in the hands of orthopedic surgeons. We look forward to identifying the best route to market for the product portfolio and rolling out the technology in the coming months.”
 
Professor James Harty, chief medical officer, said, “We have worked closely with the clinical research Facility in University College Cork and other agencies within the Health Service Executive (HSE), such that we are now in a position to commence implanting this unique nailing technology in patients at Cork University Hospital (CUH). I am very excited by this implant, and we have already completed the control arm of the data analysis and look forward to publishing data in 2018.”