The U.S. Food and Drug Administration (FDA) has awarded 510(k) clearance to QuadLock, a new knotless, bidirectional tension-adjustable fixation system from ABANZA for anterior cruciate ligament (ACL) reconstruction.

QuadLock is designed to securely fixate sutures and tapes, helping surgeons fine-tune graft tension and maintain stability across several graft configurations commonly used in ACL procedures, including quadriceps tendon, quadrupled semitendinosus/gracilis, and bone–patellar tendon–bone (BTB).

In biomechanical testing under high-demand cyclic loading, QuadLock demonstrated market-leading control of cyclic displacement (less than 0.5 mm)—a more than 500% improvement compared to the 3 mm–6 mm reported for conventional fixation methods such as cortical buttons and interference screws, according to the company. QuadLock also achieved a pullout strength of >1,000 N, combining high fixation strength with minimal displacement. Avoiding loss of tension under repeated loading is critical in early recovery, when fixation stability directly influences the restoration of functional joint stability.

ACL reconstruction remains a major procedure in sports medicine, with approximately 300,000 surgeries performed annually in the United States. With its combination of minimal cyclic displacement, knotless fixation, and tension adjustability, QuadLock expands surgeons’ options for consistent graft management across a broad range of patient bone quality, ABANZA bigwigs claim.

“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,” ABANZA CEO Juan Abascal stated. “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 soft-tissue fixation technology platform. Additional products in development—including LoopCap and WasherCap In Line—address indications such as biceps tendon repair and AC Joint reconstruction, MPFL and LET repair, and select foot/ankle applications including syndesmosis and Achilles repair.

ABANZA is advancing soft-tissue repair with fixation technologies designed to help surgeons deliver reliable outcomes for patients. The company’s devices are engineered to support modern surgical techniques and help surgeons achieve consistent, reliable results in soft-tissue repair.