# K110838: Ifuse Implant System

- Pathway: 510(k) (Special)
- Applicant: SI-BONE, Inc.
- Decided: Apr 21, 2011 after 27 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: 3 generations back to K930834 (1993). 11 ancestors in all.
143 later devices descend from it; 11 cite it directly.
0 of 155 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080398: SI Joint Fusion System, SI-BONE, Inc. (2008) Summary page 1.
- K092375: Modification to SI Joint Fusion System, SI-BONE, Inc. (2009) Summary page 1.

## Most influential descendants
- K122074: Ifuse Implant System (2012), 139 descendants of its own
- K123850: Ifuse Implant System (2013), 134 descendants of its own
- K131405: Ifuse Implant System (2013), 133 descendants of its own
- K110472: SI-Fix Sacroiliac Joint Fusion System (2012), 92 descendants of its own
- K141049: Ifuse Implant System (2014), 88 descendants of its own

## Indications for use
The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.

Source page: https://510kreport.com/device/K110838
Methodology: https://510kreport.com/methodology