OrthoXel is delighted to announce 510(k) clearance for the
Vertex Hip Fracture Nail (HFN).
CORK,
Ireland, May 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 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.
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. 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.
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.
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.
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 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."
About OrthoXel
Founded in 2014, OrthoXel continues to
add to its revolutionary orthopaedic trauma portfolio. They
currently offer the unique Apex Nailing Systems – Apex Tibial and
Femoral (Antegrade and Retrograde) – the only axial
micromotion-enabled nailing systems designed to stimulate callus
formation and reduce recovery time for patients. With the addition
of FDA 510(k) clearance for their Vertex system, OrthoXel has
expanded its lower extremity portfolio to increase its commercial
footprint throughout the US.
"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.
For more information visit:
https://www.orthoxel.com/products/vertex-hip-fracture-nailing-system/
Press Contact:
Thomas
Twomey, Sales & Marketing Manager
Email: 377024@email4pr.com
Tel:
(US) +1 (646) 661 3167
(IE) + 353 (0) 21 242 9500
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SOURCE OrthoXel