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The Kyphoplasty Balloon System (KYBS) is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

The Kyphoplasty Balloon System (KYBS) is designed to reduce spinal compression fracture and restore sagittal alignment. The device creates a space in the vertebral body to facilitate the insertion of bone cement and using cement dispensing plunger. The KYBS components are balloon catheter, cement dispenser and balloon dilator. The main components of the balloon catheter are the shaft, hub and the inflatable balloon located at the distal tip and inflatable balloon is covered maximum 0.03g of silicone fluid to enhance lubricity when the balloon catheter is inserted in the cannula. Radiopaque markers located at the distal and proximal end of deflated working surface allow fluoroscopic visualization of the deflated balloon catheter during positioning.