FDA clears ABANZA’s knotless fixation system for ACL reconstruction

ABANZA, a company focused on next-generation soft-tissue repair solutions, said the U.S. Food and Drug Administration has granted 510(k) clearance for QuadLock, a knotless, bidirectional, tension-adjustable fixation system designed for anterior cruciate ligament reconstruction.

The QuadLock system is intended to securely fixate sutures and tapes while allowing surgeons to fine-tune graft tension and maintain stability across several common ACL graft configurations, including quadriceps tendon, quadrupled semitendinosus/gracilis, and bone–patellar tendon–bone grafts.

In biomechanical testing under high-demand cyclic loading, QuadLock demonstrated less than 0.5 millimeters of cyclic displacement, which the company said represents a more than 500% reduction compared with the 3 to 6 millimeters reported for conventional fixation methods such as cortical buttons and interference screws. The system also achieved a pullout strength of more than 1,000 newtons, combining high fixation strength with minimal displacement.

Avoiding loss of tension under repeated loading is especially important during early recovery after ACL surgery, when fixation stability plays a key role in restoring functional joint stability, the company said.

ACL reconstruction is one of the most common procedures in sports medicine, with an estimated 300,000 surgeries performed annually in the United States. ABANZA said QuadLock’s combination of knotless fixation and tension adjustability is designed to support consistent graft management across patients with varying bone quality.

“QuadLock reflects our focus on practical innovation—giving surgeons adjustability, control, and confidence when fixation performance matters most, especially as today’s patient population continues to evolve and traditional fixations are increasingly challenged,” said Juan Abascal, chief executive officer of ABANZA. “This clearance strengthens our U.S. roadmap and supports our broader platform strategy to advance soft-tissue repair with solutions that emphasize reproducible technique and stable fixation under demanding conditions.”

QuadLock is part of ABANZA’s broader soft-tissue fixation platform. Additional products in development, including LoopCap and WasherCap In Line, are aimed at expanding the company’s portfolio into procedures such as biceps tendon repair, acromioclavicular joint reconstruction, medial patellofemoral ligament and lateral extra-articular tenodesis repair, and select foot and ankle applications, including syndesmosis and Achilles repair.

Advances in soft-tissue fixation and sports medicine technology

The clearance of QuadLock comes as sports medicine continues to see rapid innovation in soft-tissue fixation and ligament reconstruction, driven by higher patient expectations, earlier return-to-activity goals, and a broader range of patient ages and bone quality.

One major trend is the move toward knotless and adjustable fixation systems. Traditional fixation methods often require knot tying or rely on fixed-length constructs, which can make it difficult to precisely control graft tension during surgery. Newer systems are designed to allow surgeons to adjust tension intraoperatively and, in some cases, retension the graft after initial fixation, helping to reduce variability and improve reproducibility.

Biomechanical performance has also become a central focus. Cyclic displacement—small amounts of graft movement that occur under repeated loading—has been linked to laxity and suboptimal outcomes. As a result, device developers are placing greater emphasis on minimizing displacement while maintaining high pullout strength, particularly during the early rehabilitation phase when grafts are most vulnerable.

Material science and implant design are evolving alongside fixation mechanics. Companies are refining suture tapes, anchors, and fixation constructs to distribute load more evenly and reduce stress concentrations that can contribute to graft slippage or failure. At the same time, implants are being designed to accommodate multiple graft types and surgical techniques, reflecting the lack of a one-size-fits-all approach in ACL reconstruction.

Beyond the knee, similar advances are extending into shoulder, foot and ankle, and sports-related soft-tissue repairs. Surgeons are increasingly looking for modular platforms that use familiar instrumentation and techniques across multiple procedures, rather than isolated, single-use implants.

Together, these developments reflect a broader shift in sports medicine toward fixation systems that prioritize consistency, adjustability, and biomechanical stability—attributes aimed at supporting better functional outcomes as patient demands and surgical complexity continue to grow.