OSSIOfiber® Suture Anchor 2.5-3.5 mm

The OSSIOfiber® Suture Anchor 2.5-3.5 mm is a biodegradable bone fixation device made from poly(L-lactide-co-D,L-lactide) reinforced with mineral fibers. It is preloaded on an inserter and used for suture or tissue fixation in orthopedic procedures including rotator cuff repairs, ligament repairs, and tendon repairs in the shoulder, foot, ankle, knee, hand, wrist, and elbow in adults and children ages 2-21 with fused or non-crossing growth plates.

The device has the same intended use, principles of operation, and material composition as the primary predicate (Knotless SutureTak Anchors K180594) and identical composition and sterilization method (EtO) as the additional predicate (OSSIOfiber® Suture Anchor K213415). The subject device is available in smaller sizes appropriate for the pediatric population. Mechanical testing demonstrated equivalent or superior performance both initially and after in-vitro degradation compared to predicates.

ISO 10993 biocompatibility standards were referenced from previously cleared predicate and reference devices. ISO 9714 compatible instrumentations are used with the device. Static and cyclic pull-out testing was performed to verify strength and fixation properties.

The OSSIOfiber® Suture Anchor 2.5-3.5 mm shares identical intended use, material composition, manufacturing and sterilization methods with the additional predicate device K213415. Although it has slight design differences from the primary predicate K180594, mechanical testing demonstrated at least equivalent performance both initially and after in-vitro degradation, demonstrating these differences do not raise different safety or effectiveness questions. The pediatric sizing does not alter the fundamental surgical use or safety profile of the device.