Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm

The Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm is a knotless, two-component suture anchor made from PEEK (polyetheretherketone) used for soft tissue and ligament repair in the foot/ankle and hand/wrist. It consists of a fully threaded and vented anchor body with a closed eyelet, preassembled on a disposable inserter, and is intended for repair of collateral ligaments, tendons, ligament stabilization, and joint arthroplasty procedures.

The device has the same anchor diameter and fundamental design as the predicate K150648 but differs in: total length (10 mm vs. 8.5 mm predicate, but within cleared range), vented design (previously cleared in K150648 variant), closed eyelet design (previously cleared in K150648 variant), use of Arthrex 1.3 mm SutureTape instead of prior sutures, double PETG blister packaging instead of poly/Tyvek pouches, and addition of MR Safe labeling.

ASTM F3690-24 (Standard Test Method for Evaluating Suture Anchor Insertion and Pull Displacement Resistance), ISO 11607 (packaging standards), and FDA-recognized standards. Testing included cyclic pull-out testing, Failure Torque/Insertion Torque testing, packaging validation, and 5-year real-time aging shelf-life testing.