Abanza, a soft tissue fixation technology firm, has received the US Food and Drug Administration (FDA) 510(k) approval for its advanced WasherCap Mini fixation system.
WasherCap Mini is part of the WasherCap family, intended for multiple applications, including meniscal root repair and anterior cruciate ligament (ACL) reconstruction.
The system provides a knotless, adjustable-tension fixation for standard sutures and tapes.
Its suture-to-device fixation ensures superior rigid fixation without considering cancellous bone quality, resulting in superior displacement and pull-out strength performance.
According to the company, WasherCap Mini is the first suture and tape fixation device that provides a knotless, bidirectionally tension-adjustable solution, regardless of bone quality.
Abanza CEO Juan Abascal said: “FDA clearance of the WasherCap Mini is a tremendous milestone for 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.”
Abanza said WasherCap Mini is the second device in its new WasherCap family of products, designed based on its disruptive technology to advance soft-tissue repair.
In the biomechanical testing, WasherCap Mini has delivered superior fixation strength and minimal displacement during cyclic loading, compared to conventional devices.
With the FDA approval, WasherCap Mini is expected to enhance surgical outcomes for meniscal root repair surgery.
Furthermore, Abanza said its future products, the WasherCap In Line and the LoopCap, will expand its offerings for biceps tenodesis, medial collateral ligament repairs, and complex foot and ankle pathologies.
