News

ABANZA has announced that its innovative WasherCap™ Mini fixation system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This groundbreaking device is designed for a range of applications, including meniscal root repair and ACL reconstruction.

The WasherCap™ Mini is the first fixation device utilizing suture and tape technology that provides surgeons with a knotless, bidirectionally tension-adjustable solution, regardless of bone quality.

Extensive biomechanical testing has demonstrated that the WasherCap™ Mini offers superior fixation strength and minimal displacement during cyclic loading, outperforming conventional devices such as cortical buttons and suture anchors.

Meniscal root repair is rapidly growing in sports medicine, with nearly 100,000 procedures performed annually in the United States. As the first FDA-cleared knotless, bidirectionally tension-adjustable fixation system for this procedure, the WasherCap™ Mini is set to significantly improve 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 leveraging disruptive technology and a shared dedication to advancing soft-tissue repair. Future innovations, including the WasherCap™ In Line and LoopCap™, will expand ABANZA’s portfolio, providing surgeons with advanced solutions for procedures such as biceps tenodesis, medial collateral ligament repairs, and complex foot and ankle pathologies.

© Abanza Inc..