Paragon 28, has introduced the R3FLEX™ Stabilization System, designed to enhance stability in the ankle syndesmosis following injuries from fractures or high ankle sprains.
Ankle fractures are common, with over 470,000 projected cases in the U.S. for 2024. Injury to the distal tibiofibular syndesmosis occurs in about 23% of these fractures, while high ankle sprains, affecting 7-15% of all ankle sprains, are isolated injuries to the distal tibiofibular syndesmotic ligaments.
Approximately 2 million acute ankle sprains occur annually in the U.S. Traditional treatments include surgical options like cortical screws or flexible fixation to maintain fibula-tibia alignment.
The R3FLEX™ Stabilization System allows surgeons to precisely adjust and visualize tension during the repair process. Its design helps restore soft tissue anatomy, potentially reducing the risk of arthritis and the need for hardware removal.
Unlike conventional methods that require external tibial hardware, the R3FLEX™ Implant is positioned internally on the tibia, minimizing the risk of injury to surrounding nerves and veins.
The system features a suture loop connecting the tibial and fibular components, creating a durable repair. The fibular component includes a thermoplastic urethane bumper, enabling controlled micromotion to mimic natural fibula movement.
The R3FLEX™ Stabilization System comes in a sterile kit with all necessary implants and instruments, streamlining the surgical workflow and inventory management.
This system enhances Paragon 28’s extensive soft tissue portfolio, which includes products such as the Grappler® Suture Anchor System, Bridgeline™ Tape, and the R3LEASE™ Stabilization System, offering comprehensive solutions for foot and ankle repair.