Medline’s Reflex® Hybrid Nitinol Implants Receive FDA Clearance

Medline UNITE, a leading name in foot and ankle surgery

It has received 510(k) clearance from the U.S. FDA for its newest implant line, the REFLEX® HYBRID Nitinol Implant System.Medline has received FDA clearance for its Reflex® Hybrid Nitinol Implants, marking a major step in orthopedic innovation. The implants are designed specifically for fusion and fixation of small bones in the foot and ankle. They treat common conditions like bunions, hammertoes, and midfoot deformities using advanced metal technology. These implants combine Nitinol, known for its flexibility, with stainless steel, valued for strength and stability. The hybrid design offers controlled compression and durability, improving both surgical performance and patient outcomes.

The Reflex Hybrid system

It was developed with direct input from orthopedic surgeons and biomedical engineers. Medline focused on creating a solution that is clinically effective and easy to use in operating rooms. According to Scott Goldstein, Marketing Director for Medline Foot & Ankle, surgeons need tools that feel intuitive and reduce time in surgery. These implants support surgical efficiency by offering reliable handling and consistent fixation. They also adapt to a wide range of bone qualities, including osteoporotic bone, which is often difficult to treat.

The Reflex Hybrid implant family includes three main types: Reflex CORE™, Reflex WAVE™, and Reflex ARC™. Each type supports different anatomical needs and surgical preferences. Surgeons can select the most suitable implant for specific procedures, providing personalized care for each patient. All three implants deliver 360-degree continuous compression, which encourages bone healing and stability. This compression feature helps reduce complications like nonunion or implant failure.

FDA clearance for the Reflex Hybrid system adds strength to Medline’s growing orthopedic portfolio. It builds on the success of the original Reflex brand, already trusted by surgeons nationwide. The company will also provide educational programs, hands-on workshops, and in-surgery support. These efforts help ensure smooth product integration for hospital teams and private practices. Medline remains focused on improving outcomes by supporting both the surgical team and the patient experience.

By blending smart design with clinical expertise, Medline is helping redefine the future of foot and ankle care. The Reflex Hybrid Nitinol Implants represent a strong commitment to innovation, performance, and healing. With this new system, Medline empowers healthcare professionals to deliver better care and faster recovery. As the medical field evolves, solutions like Reflex Hybrid will continue to shape how surgeries are performed and patients recover.

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