OrthoXel Announces FDA 510(k) Clearance for the Vertex Hip Fracture Nail

CORK, IrelandMay 9, 2024 /PRNewswire/  

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 encounters 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 these clinical challenges head-on, offering a highly stable and versatile product.

Vertex Solution

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

Stability – The primary aim of surgical intervention for hip fractures is stabilization, Vertex achieves this with a unique design. Key features to note are two proximal interdigitating screws allowing for significantly enhanced screw fixation. It also boasts a radially fluted nail stem ensuring rotational and overall construct stability, particularly in the intertrochanteric and metaphyseal regions of the femur.

VersatilityVertex 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 lag screw proximal construct.

Usability Vertex redefines the user experience with its intuitive design and integration into existing surgical workflows. Both implants and instruments feature radiographic guides and cue’s that allow for enhanced visualization during surgery.

Douglas R. Dirschl MD, Professor and Chairman of Orthopedic 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 FDA 510k 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.”

Spotlight on: Charles Daly

OrthoXel Chief Technical Officer

Charles Daly, Chief Technical Officer and one of the co-founders of OrthoXel, is responsible for the technology development program. He leads the engineering team, setting direction for new product development and product portfolio expansion in line with company commercial objectives. He coordinates the on-going clinical use of OrthoXel’s regulatory approved products and engages with surgeons on new technology development opportunities.

He has been instrumental in the concept and design development of OrthoXel’s innovative Micromotion enabled Apex nailing systems, which have been proven to promote secondary bone healing through controlled axial micromotion with outstanding torsional stability. More recently Charles has guided the Vertex project along the journey to FDA 510(k) clearance:

“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.”

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