ORLANDO,
Fla., Feb. 26, 2025 /PRNewswire/ -- ABANZA, a
leader in advanced soft tissue repair solutions, is proud to
announce that the U.S. Food and Drug Administration (FDA) has
granted 510(k) clearance for its innovative WasherCap™ Mini
fixation system. This breakthrough device is designed for multiple
applications, including meniscal root repair and ACL
reconstruction.
ABANZA continues revolutionizing
orthopedics soft tissue repair highlighted by FDA 510(k) Clearance
for WasherCap™ Mini
The WasherCap™ Mini is the first suture and tape fixation device
that offers surgeons a knotless, bidirectionally tension-adjustable
solution — regardless of bone quality.
Rigorous biomechanical testing has shown the WasherCap™ Mini to
deliver superior fixation strength and minimal displacement during
cyclic loading when compared to conventional devices like cortical
buttons and suture anchors.
Meniscal root repair is one of the fastest-growing areas in
sports medicine, with nearly 100,000 procedures performed annually
in the United States. As the first
FDA-cleared knotless and bidirectionally tension-adjustable
fixation system for this surgery, the WasherCap™ Mini is poised to
significantly enhance surgical outcomes.
"FDA clearance of the WasherCap™ Mini is a tremendous milestone
for ABANZA," said Juan Abascal,
Chief Executive Officer at ABANZA. "Our device provides surgeons
with a highly reliable solution for suture and tape
fixation—particularly in surgeries where precise tension control is
critical. For meniscal root repair, its knotless technology
corrects extrusion and restores the meniscus to its anatomical
position, which we believe will lead to better short and long-term
outcomes, while potentially slowing the progression of
arthritis."
The WasherCap™ Mini is the second device in a new platform of
products built on disruptive technology and a shared commitment to
advancing soft-tissue repair. Upcoming innovations, including the
WasherCap™ In Line and the LoopCap™, will extend ABANZA's
portfolio, offering surgeons robust solutions for procedures like
biceps tenodesis, medial collateral ligament repairs, and
challenging foot and ankle pathologies.
About ABANZA
At ABANZA, we are revolutionizing orthopedics and arthroscopic
soft tissue repair through groundbreaking innovations. Our
cutting-edge medical devices are designed to enhance patient
outcomes and improve quality of life by empowering surgeons with
next-generation solutions in sports medicine and soft tissue
fixation.
Driven by a commitment to continuous improvement and clinical
excellence, ABANZA is at the forefront of advancing medical
technology. We are passionate about transforming patient care and
setting new industry standards.
For more information about our innovative product portfolio or
career opportunities, please visit www.abanzamed.com.
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SOURCE Abanza, Inc.
