OSSIOfiber® Suture Anchor

The OSSIOfiber® Suture Anchor is a biodegradable fastener used to attach soft tissue (sutures) to bone during orthopedic repair procedures in the shoulder, foot/ankle, knee, hand/wrist, and elbow. The device consists of an eyelet and anchor body made from poly(L-lactide-co-D,L-lactide) reinforced with mineral fibers that degrade over approximately 18 months, transferring load to surrounding tissue during healing and eliminating the need for removal surgery.

The OSSIOfiber® Suture Anchor has identical intended use, material composition, design characteristics, principles of operation, manufacturing and sterilization methods (EtO sterilization) as the primary predicate device (K213415). It has the same intended use, principles of operation, and similar material composition and design characteristics as the additional predicate Arthrex SwiveLock Anchor (K192441), with both supplied sterile and sterilized by EtO. Non-clinical performance testing demonstrated at least equivalent performance both initially and after in vitro degradation despite slight design and material differences.

Not stated in this summary.

The device is substantially equivalent because it is identical to the primary predicate (K213415) in all technological characteristics except for the addition of the Meniscal Root Repair indication, which is supported by comparative static and cyclic pull-out testing data already provided in K213415. The device also shares the same intended use, principles of operation, material composition, sterilization method, and indications (including Meniscal Root Repair) as the additional predicate Arthrex SwiveLock Anchor (K192441), with previously demonstrated equivalent non-clinical performance. These differences do not raise different questions of safety and effectiveness.