R3ACT™ Stabilization System

The Paragon 28® R3ACT™ Stabilization System was designed to offer surgeons an improved design over traditional syndesmotic fixation.

The implant is initially rigid to allow the syndesmosis to heal during the crucial early stages following surgery. Once a patient begins to weight-bear, the tibial and fibular components of the implant disengage safely within the clear space, where an internal pre-tensioned suture loop will engage to allow for dynamic motion. The pre-tensioned suture loop and Thermoplastic Polyurethane (TPU) bumper combine to allow for up to 3.5mm of diastatic motion and fibular rotation in a semi-constrained fashion. The implant disengagement notch features rounded edges that protect the internal suture and native bone in the clear space.

If necessary, multiple removal features allow the surgeon to remove the fibular and tibial components through a medial or lateral approach.

The R3ACT™ System offers surgeons implants in lengths ranging from 40 mm to 60 mm, allowing for capture of the medial cortex, with 14 mm and 17 mm notch lengths to accommodate a variety of patient anatomies to help ensure the two components safely disengage in the tibio-fibular clear space.

Cyclic loading data at 300,000 cycles demonstrated improved results for the R3ACT™ Stabilization System in limiting displacement versus two suture constructs at a clinically significant load.1 Over 300,000 cycles, R3ACT™ exhibited displacement of less than 3.5 mm (within functional range of displacement at the joint for native function) whereas both suture constructs fell outside this range.¹

1. Performance Analysis of Dynamic Syndesmosis Repair Strategies in Cyclic Loading. Paragon 28 Research and Development.