Paragon 28’s R3ACT Stabilization System for Ankle Fractures Gets 510(k) Clearance

January 19, 2022

Englewood, Colo.-based foot and ankle orthopedic devicemaker Paragon 28 has received the FDA’s 501(k) marketing clearance for its R3ACT stabilization system.

The latest addition to Paragon 28’s portfolio of ankle fracture and soft tissue products, the R3ACT system is used for syndesmotic stabilization, which reduces the separation between the tibia and fibula so that ligaments can heal.

The company plans to launch the R3ACT system on the U.S. market early this year.

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