FDA Product Code GAT: Suture, Nonabsorbable, Synthetic, Polyethylene

Under FDA product code GAT, nonabsorbable synthetic polyethylene sutures are cleared for use in soft tissue approximation and ligation.

These sutures are made from ultra-high molecular weight polyethylene or other synthetic polymers that do not degrade in tissue. Their high tensile strength and low elongation make them particularly suited for orthopedic procedures including tendon repair, ligament reconstruction, and cerclage fixation.

GAT devices are Class II medical devices, regulated under 21 CFR 878.5000 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Arthrex, Inc., Smith & Nephew, Inc. and Threadstone, LLC.