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Indications

Below are the United States cleared indications of SI-BONE products.

For more detailed information, healthcare professionals should refer to the respective product's Instructions For Use for indications, contraindications, warnings, and precautions, as well as surgical technique manuals and cleaning instructions at si-bone.com/label.
There are potential risks associated with iFuse procedures. They may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit si-bone.com/risks.

 

For indications outside the United States, please refer to product's Instructions for Use at si-bone.com/label.

 


iFuse Implant System® / iFuse 3DTM Implant System

The iFuse 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.

 

iFuse TORQ® Implant System

The iFuse TORQ 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.
  • Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The iFuse TORQ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute, and non-traumatic fractures.

The iFuse TORQ Navigation instruments are intended to be used with the iFuse TORQ Implant System to assist the surgeon in precisely locating anatomical structures in iFuse TORQ Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. iFuse TORQ Navigation instruments are intended to be used with the Medtronic StealthStation® System. 

 

iFuse Bedrock Granite® Implant System

The iFuse Bedrock Granite 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.

When connected to compatible pedicle screw systems with 5.5- or 6.0-mm posterior rods made from either titanium alloy or cobalt chrome alloy the iFuse Bedrock Granite Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

  • Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
  • Spondylolisthesis
  • Trauma (i.e., fracture or dislocation)
  • Spinal stenosis
  • Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
  • Spinal tumor
  • Pseudarthrosis
  • Failed previous fusion

When connected to compatible pedicle screws with 5.5- or 6.0-mm posterior rods made from either titanium alloy or cobalt chrome alloys, the iFuse Bedrock Granite Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally immature patients as an adjunct to thoracolumbar fusion for the treatment of progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis, as well as the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Please refer to the additional information section in the Instructions for Use on compatible pedicle screw system rods.
The iFuse Bedrock Granite Navigation instruments are intended to be used with the iFuse Bedrock Granite Implant System to assist the surgeon in precisely locating anatomical structures in iFuse Bedrock Granite Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. iFuse Bedrock Granite Navigation instruments are intended to be used with the Medtronic StealthStation® System.

 

iFuse INTRATM Allograft Implant System

The iFuse INTRA Allograft Implant System instruments are indicated for placement of the iFuse Bone allograft.
The iFuse INTRA Allograft Implant System is indicated for homologous use.

 

iFuse INTRA XTM Allograft Implant System

The iFuse INTRA X Allograft Implant System instruments are indicated for placement of the iFuse Bone allograft.
The iFuse INTRA X Allograft Implant System is indicated for homologous use.

 

SI-BONE Trackers and Universal Pin Guide

The SI-BONE Trackers and Universal Pin Guide are intended to enable navigation of SI-BONE instrumentation during spinal surgical procedures that utilize Medtronic StealthStation® Systems and Stealth Technology. The SI-BONE Trackers and Universal Pin Guide are specifically designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

 

Neuromonitoring Kit

The Neuromonitoring Kit is indicated for stimulation of peripheral motor nerves, including spinal nerve roots, for localization and identification during surgery.

 


Updated July 10, 2024

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