Here are four things to know:
1. OrthoXel is an orthopedic trauma company focused on using enhanced fracture fixation to stimulate callus formation with the goal of reducing healing time when OrthoXel intramedullary nails are implanted.
2. The Apex system’s micromotion locking mode allows controlled axial movement with torsional stability, intended to provide the ideal conditions for callus formation. The system also provides additional locking modes so the surgeon can customize the fixation to suit the patient’s needs, including standard cross-locking, true rigid fixation with multiple proximal screw clamping to generate a substantially rigid construct and dynamization locking with built-in torsional stability. The implantation kit is reusable and allows for nail implantation in any locking mode.
3. The patented Apex Tibial Nailing system is the first technology that OrthoXel will commercialize for tibial fracture treatment, followed by a second device for femoral fractures.
4. The FDA 510(k) clearance and CE mark allow the system to be commercialized in the U.S. and European markets.
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