FDA cleared the Iconix Knotless T from Riverpoint Medical on Aug 27, 2026 under K262677, a special 510(k). The device falls under product code MBI, Fastener, Fixation, Nondegradable, Soft Tissue, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.
FDA logged the submission as received on Jul 30, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).
Riverpoint Medical has 3 other decisions in the tracker over the last 12 months: K253693 (Strut Suture; No-Tie Button), K253695 (LigaMend), K253024 (ProZip Knotless Implant).