Medline's REFLEX® HYBRID Nitinol Implants Gain FDA Approval for Enhanced Foot and Ankle Surgery Solutions

Medline's New REFLEX® HYBRID Nitinol Implants

In a significant advancement in the domain of foot and ankle surgery, Medline UNITE proudly announces that it has gained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its REFLEX® HYBRID Nitinol Implant System. This innovative system, distinct in its design and functionality, aims to improve surgical outcomes and efficiency for orthopedic surgeons.

The demand for enhanced surgical solutions in foot and ankle procedures has led Medline to develop its REFLEX® HYBRID system, which offers the dual benefits of dynamic biplanar compression alongside the stability typically associated with traditional locking plates. The incorporation of nitinol staples has surged recently, owing to their effectiveness; however, their combination with static devices like locking plates has often muted their compression capabilities. The REFLEX HYBRID system addresses this limitation by merging the compressive power of nitinol staples with the stability offered by locking plates, providing a more reliable solution for indications such as Metatarsophalangeal (MTP) fusions and Lapidus procedures.

Continuing their legacy of innovation, Medline's REFLEX HYBRID implants are designed not just for effectiveness but for ease of use in surgical settings. The system includes a unique inserter, enabling surgeons to adjust the implant's placement dynamically, which is not possible with other nitinol solutions currently on the market. As Scott Goldstein, Vice President of Product Management at Medline UNITE, puts it, "REFLEX HYBRID demonstrates our commitment to delivering cutting-edge solutions for foot and ankle surgeons. It fills noticeable gaps within our competitive landscape, allowing for indication-specific designs and intraoperative adjustments."

The clinical insights by Natan Pheil, Director of Product Development at Medline UNITE, further underscore the innovative edge of the REFLEX HYBRID system. Surgeons can achieve additional joint compression before deploying the staple's compressive power by using a non-locking screw in conjunction with an eccentric drilling technique through the implant's ramp. This feature greatly enhances the precision and effectiveness of the surgical procedure, allowing for better patient outcomes during the healing phase.

Notably, the REFLEX HYBRID system was subjected to rigorous biomechanical testing by Dr. Jonathon Backus of the Steadman Clinic in Vail, CO. His comparisons between REFLEX HYBRID with cannulated screw constructs and traditional titanium plate and screw constructs revealed a significant improvement in load to failure and gapping at failure metrics. This pivotal finding indicates a clear advantage of the hybrid implant system over long-standing surgical practices, highlighting a vital breakthrough in orthopedic surgery.

Dr. Backus emphasized, "Historically, nitinol constructs have not shown superior performance compared to traditional plate and screw constructs in biomechanical testing; thus, the results of REFLEX HYBRID are particularly noteworthy and promising for the advancement of foot and ankle surgeries."

Medline UNITE's REFLEX HYBRID Nitinol Implant stands as a beacon of progress in orthopedic surgical tools, poised to shape the future of foot and ankle surgery. Healthcare providers and surgeons are encouraged to stay updated with the developments and innovations from Medline by following the Medline UNITE Foot & Ankle LinkedIn page. For more detailed information, visit Medline UNITE.

As a leading provider of medical-surgical products and supply chain solutions, Medline has over 43,000 employees and operates in more than 100 countries, making it a pivotal player in enhancing healthcare delivery worldwide. With innovations like the REFLEX HYBRID Nitinol Implant System, Medline continues to ensure that healthcare providers have the tools necessary to improve clinical, financial, and operational outcomes effectively.