# K233508: iFuse Bedrock Granite® Implant System

- Pathway: 510(k) (Traditional)
- Applicant: SI-BONE, Inc.
- Decided: Jan 26, 2024 after 87 days
- Product code: OUR (Sacroiliac Joint Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 31 generations back to K841189 (1984). 1,064 ancestors in all.
5 later devices descend from it; 5 cite it directly.
1 of 1,070 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222774: iFuse Bedrock Granite® Implant System, SI-BONE, Inc. (2022) Summary page 5.
- K223494: CD Horizon Spinal System, Medtronic (2023) Summary page 5.
- K223273: ASTRA Spine System, Spinecraft, LLC (2022) Summary page 5.

## Most influential descendants
- K241464: ARx® SAI Implant System (2024), 1 descendant of its own
- K262067: iFuse Granite Onyx™ Implant System (2026), 0 descendants of its own
- K254274: ARx® SAI Implant System (2026), 0 descendants of its own
- K252322: SIros-X System (2025), 0 descendants of its own
- K253094: iFuse Bedrock Granite Implant System (2025), 0 descendants of its own

## Indications for use
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, 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.

Source page: https://510kreport.com/device/K233508
Methodology: https://510kreport.com/methodology