OrthoXel Receives US FDA 510(k) Clearance for Its Vertex Hip Fracture Nail

Overview

OrthoXel, a company founded in 2014 and continuing it to include to its revolutionary orthopaedic trauma portfolio, announced it has received US 510(k) clearance for its Vertex Hip Fracture Nail (HFN).

Vertex HFN Innovative Approach

• The Vertex HFN offers an innovative approach to fracture fixation, aiming to enhance patient outcomes and streamline surgical procedures. 
• The current approaches to hip fracture treatment often encounter hurdles such as instability, which leads to high cutout rates, limited patient mobility post-surgery, persistent pain during recovery, and nonunion complications. 
• OrthoXel's Vertex HFN combats these clinical challenges head-on, offering a highly stable and versatile product.

The foundation of the Vertex Hip Fracture Nail system rests on three key pillars: stability, versatility, and usability.

1. Stability - The primary aim of surgical intervention for hip fractures is stabilization, Vertex achieves this with a unique design. 

• Two proximal interdigitating screws produce enhanced screw fixation. 
• The radially fluted nail stem ensures rotational and overall construct stability, particularly in the intertrochanteric and metaphyseal regions of the femur.

2. Versatility - Vertex empowers surgeons with unprecedented flexibility in fracture management. 

• The versatile design offers three proximal construct options to accommodate various fracture types, patient anatomies, and intra-operative requirements. 
• Select between two interdigitating lag screw configurations, with inferior or superior screw placement or, alternatively, a solid lag screw is available for a conventional proximal construct.

3. Usability – 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.

Words from an Experts

• Douglas R. Dirschl MD, Professor and chairman of orthopaedic surgery at Baylor College of Medicine (Houston, Texas) was engaged throughout product development of the Vertex system with OrthoXel:
• "With the exciting news of Vertex's US 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, (Chicago, Illinois) also contributed to the development of Vertex adding:
• "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."

Words from CTO: OrthoXel

"This groundbreaking technology signifies more than just a product launch; it represents a paradigm shift in hip fracture treatment. With unprecedented stability, versatility, and usability, the Vertex HFN empowers surgeons to redefine standards of care and usher in a new era of excellence in orthopaedic surgery."" - Charles Daly, chief technical officer (CTO) of OrthoXel.

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