FDA OKs Abanza’s WasherCap Mini Fixation System

Abanza, a company focused on advanced soft tissue repair solutions, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its WasherCap Mini fixation system.

The breakthrough device was designed for multiple applications, which include meniscal root repair and ACL reconstruction. According to the company, WasherCap Mini is the first suture and tape fixation device with a knotless, bidirectionally tension-adjustable solution—regardless of bone quality.

The company said that meniscal root repair is one of the quickest growing sectors of sports medicine, with almost 100,000 procedures annually in the U.S. Abanza hopes to significantly boost surgical outcomes with its knotless and bidirectionally tension-adjustable fixation system for this surgery.

Abanza also cited rigorous biomechanical testing that showed WasherCap Mini delivers superior fixation strength and minimal displacement during cyclic loading when compared to cortical buttons and suture anchors.

“FDA clearance of the WasherCap Mini is a tremendous milestone for Abanza,” said Juan Abascal, CEO 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.”