# K190230: iFuse Implant System®

- Pathway: 510(k) (Traditional)
- Applicant: SI-BONE, Inc.
- Decided: Apr 3, 2019 after 56 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: 14 generations back to K930834 (1993). 30 ancestors in all.
57 later devices descend from it; 3 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182983: iFuse Implant System®, SI-BONE, Inc. (2018) Summary page 4.

## Most influential descendants
- K193524: SI-BONE iFuse Implant System® (2020), 54 descendants of its own
- K220195: iFuse Bedrock Granite™ Implant System (2022), 32 descendants of its own
- K222774: iFuse Bedrock Granite® Implant System (2022), 20 descendants of its own
- K203247: iFuse-TORQ™ Implant System (2021), 17 descendants of its own
- K213667: iFuse-TORQ® Implant System (2022), 15 descendants of its own

## Indications for use
The iFuse Implant System is intended for sacroiliac fusion for conditions including 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. The iFuse Implant System is also intended for sacroiliac fusion to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

Source page: https://510kreport.com/device/K190230
Methodology: https://510kreport.com/methodology