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The OptumSI Implant System is intended for sacroiliac fusion for the following conditions:

• Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
• To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
• Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

The OptumSI Implant System consists of a cannulated diamond-shape, titanium implant (Ti-6Al-4V ELI, ASTM 3001) with a porous surface. The implant is available in varying lengths and are provided sterile and individually packaged. The system utilizes a transverse approach with a lateral or lateral-to-medial trajectory from the ilium to the sacrum. Instruments are provided as a reprocessable set to assist with gaining access and delivering the implant as intended. The principle operation is based on the diamond-shape and porous surface which are designed to prevent and minimize motion of the sacroiliac (SI) joint, thereby stabilizing the joint or fracture. The mechanism of action is that the interference fit allows for fixation, stabilization, and fusion.

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