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The iFuse Bedrock Granite Implant System is intended for sacroiliac joint fusion in skeletally mature patients 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 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 alloys, 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 screw systems 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 and the Medtronic StealthStation 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.

The Granite iGPS instruments and iGPS Drill Bits are compatible with Globus ExcelsiusGPS® Instrument Trackers and intended to be used with the iFuse Bedrock Granite Implant System and the Globus ExcelsiusGPS® Robotic Navigation System (including the Globus Excelsius3D® Imaging System), which is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.

Use of the iGPS instruments is limited to use only with the 9.5 mm and 10.5 mm iFuse Bedrock Granite implants.

The iFuse Bedrock Granite® Implant System consists of implants of various lengths and diameters, and associated instruments sets. Instrument sets are provided for both open and minimally invasive approaches. The titanium (Ti-6Al-4V ELI) implant consists of a porous fusion sleeve with threaded length attached to a solid post that has connection and implant placement features of a typical pedicle fixation screw. It is intended to provide sacroiliac joint fusion in the sacral alar iliac (SAI) trajectory (when used with commercially available sacroiliac joint fusion promoting devices), and foundational stabilization when connected to pedicle screw fixation systems in both the SAI and the iliac trajectories. Additionally, iFuse Bedrock Granite can be placed into the S1 pedicle. The device is designed for connection to commercially available pedicle screw systems via Ø5.5 mm or Ø6.0 mm titanium alloy or cobalt chrome alloy spinal fixation rods.

The purpose of this submission is to add an alternative option for the set screw (referred to as the Granite Point Lock Set Screw) used with the iFuse Granite Implant System.

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