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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 a vertebra, can be identified relative to a CT or MR based model, finages, or digitized landmarks for the anatomy.

SI-BONE's Navigation Tracking Instruments ("Trackers") consist of fixed and rotating elements and a pin guide. The Trackers are reusable and made from aluminum and stainless steel. The Trackers have fixed elements (posts) that support connection with reflective spheres. The Trackers can be securely attached to instruments used to place SI-BONE's implants during surgical procedures. SI-BONE's Fixed Trackers replicate the function of the Medtronic TeraTrackers. SI-BONE's Rotating Trackers replicate the function of Medtronic NavLock Trackers. SI-BONE's Universal Pin Guide replicates the function of the Medtronic Universal Drill Guide. An additional instrument is included with Fixed Trackers to allow the attachment and removal of the Fixed Trackers from the navigated instrument mounts.

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 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 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, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis, as well as the following conditions: 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.

The iFuse Bedrock Granite® Implant System consists of various lengths and diameters, and associated instruments sets. Instrument sets are provided for both open and minimally invasive approaches. The titanium (Ti-6A1-4V ELI) implant consists of a porous fusion sleeve with threaded length attached to a solid post that has connection and implant 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 iFuse TORQ® Implant System is indicated for sacroiliac joint fusion for: - Sacroiliac joint dysfunction including 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 nontraumatic 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 TORO Navigation instruments are intended to be used with the Medtronic StealthStation System.

The iFuse TORQ Implant System consists of threaded, fenestrated, cannulated, 3D-printed implants and associated instruments. Implants are constructed from medical grade titanium alloy (Ti-6A1-4V ELI per ASTM F3001). The implants are fully threaded or with a lag design and provided with optional washers. The washers are intended to add additional support under the head of the screw in situations where the bone quality is poor. The cannulated implants are compatible with off-the-shelf 3.2 mm guidewires. The implants, available in various lengths and diameters, allow for packing of autograft and allograft materials.

The iFuse Bedrock Granite® Implant System is intended for sacroiliac joint fusion for the following conditions: · Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the 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 alloys the iFuse Bedrock Grante 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 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.

The iFuse Bedrock Granite® Implant System consists of implants of various lengths and diameters, and associated instruments sets (for both open and minimally invasive [MIS] 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 compatible pedicle screw fixation systems in both the SAI and the Iliac trajectories. It is designed for connection to compatible commercially available pedicle screw systems via Ø5.5 mm or Ø6.0 mm diameter circular titanium alloy or cobalt chrome alloy spinal fixation rods. Please refer to the additional information section in the Instructions for Use on compatible pedicle screw system rods.

The iFuse TORQ Implant System is indicated for sacroiliac joint fusion for: · Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis. · Augmenting immobilization of the sacroiliac joint in skeletally mature patients undergoing sacropelyic 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 nontraumatic 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 TORO Navigation instruments are intended to be used with the Medtronic StealthStation System.

The iFuse TORQ Implant System consists of the iFuse-TORQ Implants and associated Instruments. consists of threaded, fenestrated, cannulated, 3D-printed implants and associated instruments. Implants are constructed from medical grade titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The implants are fully threaded or with a lag design and provided with optional washers. The washers are intended to add additional support under the head of the screw in situations where the bone quality is poor. The cannulated implants are compatible with off-theshelf 3.2 mm guidewires. The implants, available in various lengths and diameters, allow for packing of autograft and allograft materials.

The iFuse-TORQ Implant System is indicated for: · Fusion of the sacroiliac joint for sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis · Fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures

The iFuse-TORO Implant System consists of the iFuse-TORO Implants and associated Instruments. iFuse-TORQ implants are fully threaded or with a lag design and provided with optional washers. The washers are intended to add additional support under the head of the screw in situations where the bone quality is poor. The cannulated implants are compatible with off-the-shelf 3.2 mm guidewires. The iFuse-TORQ implants, that are available in various lengths and diameters, allow for packing of autograft and allograft materials.

The iFuse Bedrock Granite Implant System is intended for sacroiliac joint fusion for the following conditions: ·Sacrollac 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 period and have persisted postpartum for more than 6months. • To augment immobilization and stabilization of the sacroliac 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 the SeaSpine Mariner Pedicle Screw System, 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 withdegeneration 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 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.

The iFuse Bedrock Granite™ Implant System consists of implants of various lengths and diameters, and associated instruments sets (Open and MIS). The titanium (Ti-6AI-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 the SeaSpine Mariner Pedicle Screw System in both the SAI and the Iliac trajectories. It is designed for connection to the SeaSpine Mariner Pedicle Screw System via Ø5.5mm or Ø6.0mm titanium alloy or cobalt chrome spinal fixation rods.

The iFuse-TORQ™ Implant System is indicated for: · Fusion of the sacroiliac joint for sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis. · Fracture fixation of small and large bones of the pelvis

The iFuse-TORO Implant System consists of the iFuse-TORO Implants and associated Instruments which are included in two Instrument Sets: iFuse-TORQ Instrument Set and iFuse-TORQ Revision Instrument Set. The iFuse-TORQ Implant System is designed to provide a non-impacted, threaded solution for sacroiliac joint fusion, as well as compression across the SI joint, and for fracture fixation of small and large bones of the pelvis. The iFuse-TORQ Implants are sterile, single use 3D-printed implants that are provided in various lengths and diameters, and feature flutes and multiple fenestrations along the shaft length (Table 1). The iFuse-TORO Implants are provided in two primary configurations – fully threaded and lag implant designs with optional washers. The cannulated implants include a tapered distal tip and dualsingle-dual lead threads that are compatible with off-the-shelf 3.2 mm guidewires. The iFuse-TORQ Implant designs allow for packing of autograft and allograft materials. The iFuse-TORO Instruments are provided in two sets: iFuse-TORO Instrument Set (with Primary and Navigation Instruments) and the iFuse TORO Revision Instrument Set. The iFuse-TORO Instruments Sets consist of single use, disposable and reusable instruments. The instruments are provided non-sterile and are intended for cleaning and steam sterilization by the user prior to each use. The iFuse-TORQ Instruments consist of both Class II and Class I medical devices which facilitate the introduction, adjustment / positioning, final placement, and removal (if required) of the implants in the target anatomy.

iFuse-Implant System - iFuse-Navigation Instrument Set is intended to be used with the iFuse Implant System to assist the surgeon in precisely locating anatomical structures 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-Navigation instruments are intended to be used with the Medtronic StealthStation System.

iFuse Implant System - iFuse-Navigation Instrument Set is comprised of reusable manual surgical instruments specifically designed for use with the iFuse Implant System®. These instruments are designed to interface with the already-cleared Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures for placement of iFuse implants. This surgical imaging technology provides visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to dynamic, graphical representation of multi-plane 3D images (and 2D images) providing indication of instrument and implant placement.

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 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 iFuse Implant System consists of cannulated triangular, titanium implants Ti-6A1-4V ELI, ASTM F136/F1580 and iFuse-3D implants: Ti-6A1-4V ELI, ASTM F3001 with a porous surface and an instrument system. The principle of operation is based on the triangular implant shape and porous surface which are designed to prevent and minimize motion / micromotion of the sacroiliac (SI) joint, and thereby stabilize the joint or fracture. The mechanism of action is that the interference fit allows for fixation, stabilization and fusion. The implants are available in varying lengths and diameters and are provided sterile (gamma sterilization).