ABANZA's QuadLock™ Fixation System Achieves FDA Approval for ACL Surgeries
ABANZA Secures FDA 510(k) Clearance for QuadLock™ Fixation System
ABANZA, a leading innovator in soft-tissue repair solutions, has made a significant advancement in orthopedic surgery with the U.S. Food and Drug Administration (FDA) granting 510(k) clearance for its latest product, the QuadLock™ fixation system. This innovative system is designed specifically for anterior cruciate ligament (ACL) reconstruction, a procedure that is increasingly performed, with approximately 300,000 surgeries occurring annually in the United States alone.
What is QuadLock™?
QuadLock™ is a state-of-the-art, knotless, bidirectional tension-adjustable fixation system that boasts significant advantages over traditional fixation methods. The system provides outstanding fixation strength, achieving over a 500% reduction in cyclic displacement compared to conventional techniques such as interference screws or cortical buttons. This is particularly critical in maintaining joint stability during the initial recovery phase, where securing tension is crucial for the restoration of functional mobility.
In rigorous biomechanical testing, QuadLock™ has demonstrated exceptional control over cyclic displacement, keeping it below 0.5 mm under high-demand cyclic loading. This level of precision allows surgeons to fine-tune graft tension effectively, which is vital for various graft configurations used in ACL surgeries, such as quadriceps tendon, quadrupled semitendinosus/gracilis, and bone–patellar tendon–bone (BTB).
The Importance of Fixation in ACL Surgery
The significance of secure graft fixation during ACL reconstruction cannot be overstated. When tension is lost due to displacement, patients risk encountering delays in recovery and functional instability. QuadLock™ excels in maintaining graft stability, with a pullout strength exceeding 1,000 N, thus combining high fixation strength with minimal displacement. The product empowers surgeons to ensure that patients can achieve swift and effective recovery outcomes.
Juan Abascal, the Chief Executive Officer of ABANZA, expressed pride in the company's commitment to practical innovation, stating, “QuadLock™ reflects our focus on providing surgeons with the control and confidence they need when fixation performance matters most.” He highlighted that this new product aligns with ABANZA's goal to adapt to the evolving needs of the patient population while overcoming the challenges posed by traditional fixation methods.
Future Directions for ABANZA
The launch of QuadLock™ is just one part of ABANZA's expanding array of soft-tissue fixation technologies. Future projects include the anticipated LoopCap™ and WasherCap™ In Line, aimed at addressing a variety of conditions such as biceps tendon repair and AC joint reconstruction. With these innovations, ABANZA is set to broaden its influence in orthopedic solutions and enhance surgical outcomes across various applications.
For those interested in learning more about QuadLock™ and the broader product pipeline offered by ABANZA, more information is available on their official website at www.abanzamed.com.
Conclusion
The FDA's approval of the QuadLock™ fixation system marks a pivotal moment in ACL reconstruction surgery. By leveraging advanced technology, ABANZA aims to set new standards within the soft-tissue repair domain, ultimately enabling healthcare professionals to achieve more reliable and effective recovery pathways for patients undergoing ACL surgeries. The integration of QuadLock™ into surgical practice is anticipated to significantly alter how orthopedic procedures are conducted, emphasizing the importance of innovation in healthcare.
Topics Health）
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