# K131405: Ifuse Implant System

- Pathway: 510(k) (Traditional)
- Applicant: SI-BONE, Inc.
- Decided: Oct 16, 2013 after 154 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: 6 generations back to K930834 (1993). 17 ancestors in all.
133 later devices descend from it; 10 cite it directly.
0 of 151 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)
- K122074: Ifuse Implant System, SI-BONE, Inc. (2012) Summary page 1.
- K123850: Ifuse Implant System, SI-BONE, Inc. (2013) Summary page 1.
- K102903: Pioneer Cannulated Screw System, Pioneer Surgical Technology, Inc. (2010) Summary page 1.

## Most influential descendants
- 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
- K151718: iFuse Implant System (2015), 85 descendants of its own
- K152681: iFuse Implant System (R) (2016), 84 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/K131405
Methodology: https://510kreport.com/methodology