OrthoXel announced that it received FDA 510(k) clearance for its Vertex hip fracture nail (HFN) for fracture fixation.
The Cork, Ireland-based company says its nail can enhance patient outcomes while streamlining surgical procedures. Current approaches face speedbumps like instability, limited patient mobility, pain during recovery and more. OrthoXel says its nail combats those challenges head-on with a stable, versatile product.
Related: RapidAI Secures FDA Clearance for Perfusion Imaging in the Angiography Suite
According to a news release, Vertex’s unique design features interdigitating screws for enhanced screw fixation. The radially fluted nail stem ensures rotational and overall construct stability.
The company says its nail empowers surgeons with unprecedented flexibility in fracture management. Its versatile design offers three proximal construct options to accommodate various fracture types, patient anatomies and intraoperative requirements.
OrthoXel said Vertex also redefines the user experience with its intuitive design and integration into existing surgical workflows. Implants and instruments feature radiographic guides and cues allowing for enhanced visualization during surgery.
Dr. Jason Strelzow, director of orthopedic trauma and residency program director at The University of Chicago Medicine, contributed to the development of Vertex. Strelzow said:
“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.”
