Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II

Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II is an FDA 510(k)-cleared medical device (K221128) manufactured by Arthrex, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 4, 2022. Regulation: 8.