Launch of Grappler® R3INFORCE™ Extraosseous Repair System

March 28, 2024by Jim Edson

Paragon 28 Adds to Suite of Novel Syndesmosis Repair Solutions with Launch of Grappler® R3INFORCE™ Extraosseous Repair System

Paragon 28, Inc. (NYSE: FNA), is pleased to announce the launch of the Grappler® R3INFORCE™ Extraosseous Repair System designed to restore stability to the anterior and posterior ligaments surrounding the ankle during fibula fracture repairs and high ankle sprains.

Upon determination of syndesmotic instability, the Grappler® R3INFORCE™ Anchors are placed in plate holes or other anatomic locations where pre-loaded suture tape can be routed and tensioned to address the injured ligament or ligaments. The Dynamic Anchor allows for micromotion in the repair to better replicate the mechanics of the native tissue.

grappler r3inforce
Figure 1: Anterior inferior tibiofibular ligament (“AITFL”) Repair Showing the Grappler® R3INFORCE™ Dynamic Anchor (left) and Grappler® Knotless Anchor (center). Complete Extraosseous Repair with Grappler® R3INFORCE™ System shown on right.

This system is highly synergistic with Paragon 28’s existing offerings and can utilize the recently launched Grappler® Knotless Sutures. This compatibility allows for multiple configurations for surgeons to cater their syndesmotic repair to their own treatment philosophies.

The Grappler® R3INFORCE™ Extraosseous Repair System is sterile packed and includes all instrumentation needed to complete the case in multiple configurations, reducing waste and intraoperative complexity.

Paragon 28’s CEO, Albert DaCosta, commented, “With up to 25% of all ankle fractures as well as unstable high ankle sprains requiring implants to facilitate soft tissue healing, syndesmotic stabilization is a major priority for Paragon 28 and an opportunity for us to improve patients’ recoveries. In launching the Grappler® R3INFORCE™ System and Dynamic Knotless Anchor, we are adding to our comprehensive and growing suite of novel solutions designed specifically to treat injuries to the highly complex syndesmosis.”

Surgeon Designer Mark Davies, MD, commented, “Congratulations to the blue sky thinking and creativity of the Paragon 28 team in manufacturing the Grappler® R3INFORCE™ Extraosseous Repair System. It offers surgeons a comprehensive, physiological, and anatomical reconstruction system for ankle syndesmotic injuries.”

The Grappler® R3INFORCE™ Extraosseous Repair System bolsters Paragon 28’s soft tissue offering, which includes the Paratrooper™ Plantar Plate System, TenoTac™ 2.0 Soft Tissue Fixation System, Grappler® Interference Screw System, Grappler® Suture Anchor System, Grappler® Knotless Anchor System, Bridgeline™ Tape, R3ACT® Stabilization System, R3LEASE™ Stabilization System, and Mister Tendon™ Harvester. With this comprehensive portfolio, Paragon 28® provides its customers with a single source to address their foot and ankle soft tissue needs.

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