ORGANOGENESIS INC. 550-006 PuraForce™

PuraForce ™ tendon reinforcement matrix is a resorbable collagen based material intended for implantation to reinforce soft tissue. The device is supplied sterile in double layer peel-open packaging. The product is packaged hydrated and is ready to use. PuraForce ™ is intended for reinforcement of soft tissues repaired by sutures or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps and quadriceps or other tendons.PuraForce ™ is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps and quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. PuraForce reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient’s own soft tissue.