Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor)

The Crius PEEK Suture Anchor System is a soft-tissue-to-bone fixation device consisting of a PEEK anchor body, UHMWPE suture, and disposable inserter. It is used to reattach soft tissues (tendons, ligaments) to bone in orthopedic procedures across the shoulder, knee, hip, elbow, foot/ankle, hand, and wrist.

The device has the same intended use, design features, materials (PEEK anchor, UHMWPE suture), and sterilization methods as the predicate devices. Any technological differences are considered minor and do not raise different safety or effectiveness questions.

ASTM F543-17, ASTM F1839-08, and FDA Guidance 'Bone Anchors - Premarket Notification (510(k)) Submissions' (March 3, 2020). Testing included insertion force, insertion torque, torsional strength, pullout strength, and fatigue strength testing.

The subject device demonstrated substantially equivalent performance to the predicate device across all tested mechanical parameters (insertion force/torque, strength, fatigue). Acceptance criteria were based on similar-sized predicate suture anchors, and the subject device met those criteria. The materials, design, intended indications, and sterilization are identical to predicates, with only minor technological differences that do not create new safety or effectiveness concerns.