Irish medical technology firm OrthoXel has received the US Food and Drug Administration (FDA) 510(k) clearance for the Vertex Hip Fracture Nail (HFN).
Vertex HFN is a surgical intervention system designed for fracture fixation, improve patient outcomes, and streamline surgical procedures.
The system aims to address challenges associated with existing hip fracture treatment like instability, which results in high cutout rates and limited patient mobility after surgery.
Vertex HFN also offers a stable and versatile product to eliminate persistent pain during recovery and nonunion complications.
The fracture fixation system has two proximal interdigitating screws that produce improved screw fixation to stabilise the fracture.
Additionally, it has a radially fluted nail stem that ensures stability against rotation and overall construct stability, particularly in the intertrochanteric and metaphyseal regions of the femur.
Vertex is engineered to empower surgeons with multiple options for fracture management.
Its adaptable design provides three proximal construct options to address different fracture types, patient anatomies, and intra-operative needs, OrthoXel said.
The options include two interdigitating lag screw configurations, with inferior or superior screw placement, and a solid lag screw for a traditional proximal construct.
Furthermore, Vertex HFN has an intuitive design that seamlessly integrates into existing surgical workflows.
The medical technology company said the implants and instruments feature radiographic guides and cues to boost visualisation during surgery and streamline the surgical process.
Houston, Texas-based Baylor College of Medicine orthopaedic surgery chairman Douglas Dirschl was engaged in the Vertex system’s development with OrthoXel.
Dirschl said: “With the exciting news of Vertex’s FDA 510(k) clearance, I eagerly anticipate this innovative nail providing benefit to my patients and those of other fracture surgeons.
“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.”
Established in 2014, OrthoXel has a rapidly expanding orthopaedic trauma portfolio.
The Irish firm currently offers Apex Nailing Systems that includes Apex Tibial and Femoral (Antegrade and Retrograde) to promote callus formation and minimise recovery time for patients.
