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The AFFIRM™ VCF System is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius, and calcaneus. This includes percutaneous vertebral augmentation. Vertebral compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancer and myeloma. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

The AFFIRM™ Inflatable Bone Tamp is a bone tamp with an inflatable balloon attached to the distal end, designed to create a void in cancellous bone. The Inflatable Bone Tamp is a sterile, single-use device manufactured from polvurethane. The system also contains access instruments (including drills, cannulas, jamshidi needles, and K-wires), biopsy needle, cavity preparation instruments (expanding scraper), sleeve, an inflation device, and cement delivery instruments (cement mixer, cement guns, and filler delivery needles).