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 during orthopedic surgical procedures. It features a braided polyester sleeve interlaced with two #2 suture strands and is deployed via a disposable stainless steel inserter through a predrilled hole. The device stabilizes damaged soft tissue in conjunction with postoperative immobilization.

The OTS 25-L uses a flat suture/sleeve structure that bunches during deployment to achieve bone fixation through suture shape changes in cancellous bone, preventing pullthrough at the hard bone interface. It shares the same #2 UHMWPE suture attachment method and fork-shaped insertion mechanism as predicates. The main difference is a distal extension placed on the tendon to reduce suture cut-through risk by distributing force across a larger area, similar to tape-based anchors.

Not stated in this summary.

The OTS 25-L demonstrates substantial equivalence because it has identical intended use and indications as predicates OTS 25 (K233429) and Y-Knot RC (K133224) for reattaching soft tissue to bone. It employs the same suture-only bone fixation mechanism, soft tissue attachment method, and 8-step insertion procedure. The distal extension difference does not raise new safety or effectiveness issues, as nonclinical testing (insertion, pullout, cyclic loading) shows equivalent or superior performance to predicates, with no new materials or biocompatibility concerns.