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The CASSATT™ SU Fixation System is intended for fixation of sacroiliac joint disruptions and intended for sacrolliac joint fusion for conditions including.

· Sacroiliac joint disruptions,

· Degenerative sacroiliitis,

· To augment immobilization and stabilization of the sacroillac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and

· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

The CASSATT™ SIJ Fixation System is a cannulated screw system, including head washer. The system offers various sizes to accommodate a wide range of anatomies. These devices come in various sizes to accommodate patient anatomy, which are all manufactured from titanium alloy, as specified in ASTM F136.

The provided text is a 510(k) Summary for the CASSATT™ SIJ Fixation System. This document outlines the rationale for the device's substantial equivalence to previously cleared devices. It does not describe an AI/ML powered medical device, therefore, the requested information about acceptance criteria, study that proves device meets acceptance criteria, sample sizes, experts, adjudication methods, MRMC studies, standalone performance, ground truth, and training set information is not applicable.

The document focuses on the mechanical performance of a medical implant and compares it to predicate devices based on established ASTM standards.

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