Rachel Klemovitch, Assistant Editor05.09.24
OrthoXel has received 510(k) clearance from the FDA for its Vertex Hip Fracture Nail (HFN). This product aims to enhance patient outcomes and streamline surgical procedures for a stable result.
The system focuses on stability, versatility, and usability, aiming to combat the clinical challenges of current hip fracture treatments.
The Vertex HFN uses two proximal interdigitating screws to produce enhanced screw fixation. The radially fluted nail stem is designed to provide rotational and overall construct stability, particularly in the intertrochanteric and metaphiyseal regions of the femur.
The system offers flexible fracture management with three proximal construct design options to accommodate various fracture types, patient anatomies, and intra-operative requirements. There are two interdigitating lag screw configurations with inferior or superior screw placement. A solid lag screw is also available for a conventional proximal construct.
Vertex redefines the user experience with its intuitive design and integration into existing surgical workflows. Both implants and instruments feature radiographic guides and cues that allow for enhanced visualization during surgery.
Douglas R. Dirschl MD, Professor and Chairman of Orthopedic Surgery at Baylor College of Medicine, and contributor to product development of the Vertex system with OrthoXel commented: "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."
Jason Strelzow MD, Director of Orthopaedic Trauma and Residency Program Director at The University of Chicago Medicine, and development contributor added: "I am very excited to see the Vertex nail reach the market. 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."
The system focuses on stability, versatility, and usability, aiming to combat the clinical challenges of current hip fracture treatments.
The Vertex HFN uses two proximal interdigitating screws to produce enhanced screw fixation. The radially fluted nail stem is designed to provide rotational and overall construct stability, particularly in the intertrochanteric and metaphiyseal regions of the femur.
The system offers flexible fracture management with three proximal construct design options to accommodate various fracture types, patient anatomies, and intra-operative requirements. There are two interdigitating lag screw configurations with inferior or superior screw placement. A solid lag screw is also available for a conventional proximal construct.
Vertex redefines the user experience with its intuitive design and integration into existing surgical workflows. Both implants and instruments feature radiographic guides and cues that allow for enhanced visualization during surgery.
Douglas R. Dirschl MD, Professor and Chairman of Orthopedic Surgery at Baylor College of Medicine, and contributor to product development of the Vertex system with OrthoXel commented: "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."
Jason Strelzow MD, Director of Orthopaedic Trauma and Residency Program Director at The University of Chicago Medicine, and development contributor added: "I am very excited to see the Vertex nail reach the market. 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."