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The STR GRAFT is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The STR GRAFT is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The STR GRAFT is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures used to repair the tear, and sutures or bone anchors, used to attach the tissue to bone, provide mechanical strength for the tendon repair.

The STR GRAFT is a bioresorbable, three-dimensionally (3-D) braided construct made of poly-L-lactic-acid (PLLA) fiber. The STR GRAFT is available in rectangular and square sizes of 23 mm x 12 mm, 23 mm x 23 mm x 40 mm, and 23 mm x 60 mm; all STR GRAFT devices are approximately 1.0 mm thick; with the thickness comprised of three layers of 3-D braided fiber bundles. The STR GRAFT is supplied sterile (EtO) and is single-use only.