Strut Suture; No-Tie Button

Strut Suture; No-Tie Button is an FDA 510(k)-cleared medical device (K253693) manufactured by Riverpoint Medical, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 10, 2026. Regulation: 8.