OrthoXel has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Vertex Hip Fracture Nail (HFN), designed to improve hip fracture treatment.
The Vertex HFN is designed to address common challenges faced in hip fracture management such as instability and high cutout rates, which can impede patient recovery and mobility.
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OrthoXel’s system aims to provide a stable and versatile solution for surgeons, enhancing the surgical procedure and potentially improving patient outcomes.
The system features two proximal interdigitating screws for enhanced fixation and a radially fluted nail stem for rotational stability, particularly in critical regions of the femur.
Furthermore, the Vertex HFN includes three proximal construct options, allowing for customisation based on intra-operative requirements.
These options include two interdigitating lag screw configurations with different placements and a solid lag screw for a more traditional approach.
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By GlobalDataOrthoXel said the intuitive design of the Vertex system allows it to be integrated seamlessly into existing surgical workflows.
The implants and instruments come with radiographic guides and cues for better visualisation during surgery, simplifying the process for medical professionals.
Baylor College of Medicine in Houston orthopaedic surgery chairman Douglas Dirschl was involved in the product development with OrthoXel.
Dirschl said: “The Vertex’s design offers enhanced stability as well as the flexibility to tailor treatment to individual patient and fracture needs.
“Like with their Apex nail, the OrthoXel team has once again demonstrated excellence and innovation in product design.”
University of Chicago Medicine residency programme director and orthopaedic trauma director Jason Strelzow also contributed to the development of the Vertex system.
Strelzow said: “Working with the development team they have created a one-of-a-kind system taking advantage of the existing knowledge of hip fracture nails and generated a novel, innovative design that addresses the biggest concerns around hip fracture fixation.
“The fluted interference fit, combined with enhanced head/neck fixation through the interdigitating screw design provides an exciting and potentially game-changing tool for these injuries.”
