OTS 25-L (100-5)

The OTS 25-L is an all-suture anchor used to reattach soft tissue (ligaments, tendons, joint capsules) to bone in orthopedic surgical procedures. It consists of a braided polyester sleeve interlaced with two #2 suture strands and is provided preloaded on a disposable stainless-steel inserter for single use in either arthroscopic or open surgery.

The subject device is identical in all technological characteristics to the predicate OTS 25-L (K241234). The only difference is a labeling change permitting the extension component above the bone surface to be optionally filled with autologous bone marrow to serve as an interface for soft tissue augmentation.

Not stated in this summary.

The device is substantially equivalent because it has the same intended use, indications, technological characteristics, and principles of operation as the previously cleared OTS 25-L predicate (K241234). The labeling change to permit optional autologous bone marrow fill was supported by GLP animal testing showing the investigational device was at least equivalent to the cleared predicate in tissue healing and strength of attachment, with no adverse findings in systemic or local safety parameters.