# K193524: SI-BONE iFuse Implant System®

- Pathway: 510(k) (Traditional)
- Applicant: SI-BONE, Inc.
- Decided: Mar 31, 2020 after 103 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: 15 generations back to K930834 (1993). 31 ancestors in all.
54 later devices descend from it; 9 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190230: iFuse Implant System®, SI-BONE, Inc. (2019) Summary page 4.
- K110838: Ifuse Implant System, SI-BONE, Inc. (2011) Summary page 4.
- K092375: Modification to SI Joint Fusion System, SI-BONE, Inc. (2009) Summary page 4.

## Cited in the summary but kept off the family tree
- K080298: Dermabiosafe, Complete Product Resources (2008). Our reading of the summary gave K080298, FDA’s number for Dermabiosafe (Complete Product Resources). Its FDA name has none of the distinctive words the summary uses for the device it names, “SI-BONE iFuse Implant System®”. Kept off the family tree. Summary page 4.

## Most influential descendants
- 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
- K222605: iFuse TORQ® Implant System (2022), 14 descendants of its own

## Indications for use
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 peripartum 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.

Source page: https://510kreport.com/device/K193524
Methodology: https://510kreport.com/methodology