# K220195: iFuse Bedrock Granite™ Implant System

- Pathway: 510(k) (Traditional)
- Applicant: SI-BONE, Inc.
- Decided: May 26, 2022 after 122 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: 16 generations back to K930834 (1993). 160 ancestors in all.
32 later devices descend from it; 6 cite it directly.
0 of 193 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193524: SI-BONE iFuse Implant System®, SI-BONE, Inc. (2020) Summary page 5.
- K212692: Mariner Pedicle Screw System, SeaSpine Orthopedics Corporation (2021) Summary page 5.
- K172268: iFuse Implant System- iFuse Navigation, SI-BONE, Inc. (2017) Summary page 5.

## Most influential descendants
- K222774: iFuse Bedrock Granite® Implant System (2022), 20 descendants of its own
- K232275: Invictus® Spinal Fixation System (2023), 11 descendants of its own
- K233508: iFuse Bedrock Granite® Implant System (2024), 5 descendants of its own
- K242364: IdentiTi™ II Interbody System (2024), 4 descendants of its own
- K241574: iFuse TORQ® Implant System (2024), 4 descendants of its own

## Indications for use
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 sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6months. •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 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.

Source page: https://510kreport.com/device/K220195
Methodology: https://510kreport.com/methodology