# K122074: Ifuse Implant System

- Pathway: 510(k) (Traditional)
- Applicant: SI-BONE, Inc.
- Decided: Oct 12, 2012 after 88 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: 4 generations back to K930834 (1993). 12 ancestors in all.
139 later devices descend from it; 9 cite it directly.
0 of 152 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.
- K110838: Ifuse Implant System, SI-BONE, Inc. (2011)

## Most influential descendants
- K123850: Ifuse Implant System (2013), 134 descendants of its own
- K131405: Ifuse Implant System (2013), 133 descendants of its own
- K141049: Ifuse Implant System (2014), 88 descendants of its own
- K150875: iFuse Implant System (2015), 86 descendants of its own
- K150714: SI-BONE iFuse Implant System (2015), 86 descendants of its own

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

Source page: https://510kreport.com/device/K122074
Methodology: https://510kreport.com/methodology