Search Results

The Stryker® iVAS Inflatable Vertebral Augmentation System (system) is intended to be used for the reduction 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 procedures, such as kyphoplasty.

The Stryker® IVAS balloon catheter is a bone tamp with an inflatable component (balloon) at the distal end. The balloon is inflated to create a void within the vertebral body.

This 510(k) summary for the Stryker® IVAS Balloon Catheter (K093419) does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document is a submission for substantial equivalence to a predicate device (Kyphx Xpander Inflatable Bone Tamps, K041454). The core of the argument is that the Stryker® IVAS balloon catheter is "equivalent in intended use, technological characteristics, safety, and effectiveness" to the predicate, and does not "raise any new safety and efficacy concerns."

Therefore, I cannot populate the table or answer the questions based on the provided text. The document focuses on establishing equivalence rather than presenting an independent performance study with defined acceptance criteria.

Ask a specific question about this device