FDA Grants 510(k) Clearance to OrthoXel's Vertex Hip Fracture Nail

Friday, May 10, 2024

The Vertex HFN introduces an innovative approach to fracture fixation, aiming to enhance patient outcomes and streamline surgical procedures.

Current methods for treating hip fractures often encounter challenges like instability, leading to complications such as screw cutout, limited mobility after surgery, persistent pain during recovery, and difficulties with bone healing.

OrthoXel's Vertex HFN directly addresses these issues, offering a highly stable and adaptable solution.

Key Features of the Vertex Solution:

  • Stability: The primary goal of hip fracture surgery is to stabilize the fracture, and Vertex achieves this through a unique design. Two interdigitating screws at the proximal end provide superior screw fixation, while the radially fluted nail stem ensures stability, especially in critical regions of the femur like the intertrochanteric and metaphyseal areas.
  • Versatility: The Vertex system empowers surgeons with unprecedented flexibility in managing fractures. Its design offers three proximal construct options to suit different fracture types, patient anatomies, and surgical requirements. Surgeons can choose between two configurations of interdigitating lag screws, with screws placed either superiorly or inferiorly, or opt for a conventional proximal construct with a solid lag screw.
  • Usability: Vertex revolutionizes the surgical experience with its intuitive design, seamlessly integrating into existing surgical workflows. Both implants and instruments feature radiographic guides and cues, enhancing visualization during surgery and facilitating smoother procedures.

Expert Endorsements:

  • Chairman of Orthopedic Surgery at Baylor College of Medicine, expresses anticipation for the Vertex system's FDA 510(k) clearance, highlighting its potential to benefit patients through enhanced stability and personalized treatment options. He commends OrthoXel for once again demonstrating excellence and innovation in product design, following the success of their Apex nail.
  • Director of Orthopaedic Trauma and Residency Program Director at The University of Chicago Medicine, praises the Vertex nail as a unique system that addresses major concerns in hip fracture fixation. He emphasizes the novel design's potential to be a game-changer in treating these injuries, particularly highlighting its fluted interference fit and enhanced fixation at the head/neck junction through interdigitating screws.

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