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The COHESION Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

The purpose of this submission is to submit a new bone cement that is a modification of Vertecem and Opacity+ bone cements, previously cleared on K090435 and K080873, respectively. Cohesion has the same indications for use as the predicate devices. Another similarity is that the cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box. Cohesion is a self-hardening and ready to use bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. Like its predicates Cohesion allows an excellent consolidation of the vertebral body and an effective and rapid pain relief.