ABANZA Receives FDA 510(k) Clearance for WasherCap™ Mini Implantable Fixation Device

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.

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.

SOURCE Abanza, Inc.