Device Information
The iFuse Bedrock Granite Implant System consists of titanium alloy (Ti-6Al-4V ELI) implants of various lengths and diameters. It is designed for both open and minimally invasive surgeries. The implants feature a porous fusion sleeve with a threaded length attached to a solid post, allowing for connection with 5.5 mm or 6.0 mm titanium or cobalt chrome rods. The system provides sacroiliac joint fusion and spinal stabilization, particularly in the sacral alar iliac trajectory.
Indications for Use
The iFuse Bedrock Granite Implant System is intended for:
- Sacroiliac joint dysfunction that is caused by sacroiliac joint disruption or degenerative sacroiliitis. This includes cases that started during pregnancy and lasted more than six months postpartum.
- Stabilizing and immobilizing the sacroiliac joint in patients undergoing sacropelvic fixation as part of lumbar or thoracolumbar fusion.
- Treating fractures of the sacroiliac joint, whether acute, non-acute, or non-traumatic.
The iFuse Bedrock Granite Implant System, when connected to compatible pedicle screws and rods is designed to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion. It is indicated for conditions such as degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, spinal deformities, tumors, pseudarthrosis, and failed previous fusions.
The iFuse Bedrock Granite Implant System, when connected to compatible pedicle screws and rods, is intended to provide immobilization and stabilization of spinal segments in skeletally immature patients as an adjunct to thoracolumbar fusion. This system is indicated for treating progressive spinal deformities such as scoliosis, kyphosis, and lordosis, as well as conditions like spondylolisthesis, fractures due to tumor or trauma, pseudarthrosis, and failed previous fusions, using a posterior approach with autograft and/or allograft.
Intended Use
By trained orthopedic surgeons in operating rooms.
Availability
- Type: Prescription use only
Study Results
Performance tests include static and dynamic compression, torsion testing, axial pullout testing, and fatigue testing. Results demonstrate that the iFuse Bedrock Granite Implant System is substantially equivalent to the predicate device in both safety and efficacy.
The iFuse Bedrock Granite® Implant System underwent several nonclinical and safety tests to demonstrate its safety and efficacy. These include static and dynamic cantilever testing per ASTM F2193, post-fatigue sleeve dissociation testing, and static torsion testing per ASTM F543.
Additionally, the system underwent static axial pull-out testing and construct testing (static and dynamic compression bending, static torsion) per ASTM F1717. The results from these tests showed that the device is substantially equivalent to its predicate in terms of safety and performance.
Regulatory Information
- Regulation Number: 21 CFR 888.3040
- Regulatory Class: Class II
- Product Code: OUR, NKB, OLO
- 510(k) Number: K233508
The iFuse Bedrock Granite® Implant System must comply with several FDA regulations. These include 21 CFR 888.3040 for smooth or threaded metallic bone fixation fasteners, 21 CFR 888.3070 for thoracolumbosacral pedicle screw systems, and 21 CFR 882.4560 for stereotaxic instruments. In addition, the device is subject to 21 CFR Part 820, which covers the Quality System (QS) regulation, ensuring proper design, manufacturing, and testing, as well as 21 CFR Part 807 for registration and listing and 21 CFR Part 803 for medical device reporting.
Manufacturer Information
- Company: SI-BONE, Inc.
- Address: 471 El Camino Real, Suite 101, Santa Clara, CA 95050
- Contact: Jayasri Prabakaran, Associate Director, Regulatory Affairs
Predicate Device Information
- Predicate Devices: iFuse Bedrock Granite Implant System, K222774, CD Horizon Spinal System by Medtronic Sofamor Danek K223494, SpineCraft, LLC SpineCraft, LLC K223273
- Is Predicate an Earlier Version?: Yes
- Differences: The current device has reduced diameter and length compared to the predicate device, but no critical changes to intended use or function.
Implications
This system provides an option for spinal stabilization in patients with sacroiliac joint dysfunction, deformities, or fractures.
References
- iFuse Bedrock Granite Implant System. 510(k) Number: K233508. FDA summary link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K233508
- Manufacturer website: https://www.si-bone.com
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