# K152681: iFuse Implant System (R)

- Pathway: 510(k) (Traditional)
- Applicant: SI-BONE, Inc.
- Decided: Mar 1, 2016 after 165 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: 10 generations back to K930834 (1993). 26 ancestors in all.
84 later devices descend from it; 1 cites it directly.
0 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110838: Ifuse Implant System, SI-BONE, Inc. (2011) Summary page 4.
- K122074: Ifuse Implant System, SI-BONE, Inc. (2012) Summary page 4.
- K123850: Ifuse Implant System, SI-BONE, Inc. (2013) Summary page 4.
- K131405: Ifuse Implant System, SI-BONE, Inc. (2013) Summary page 4.
- K141049: Ifuse Implant System, SI-BONE, Inc. (2014) Summary page 4.
- K150714: SI-BONE iFuse Implant System, SI-BONE, Inc. (2015) Summary page 4.
- K150875: iFuse Implant System, SI-BONE, Inc. (2015) Summary page 4.
- K151718: iFuse Implant System, SI-BONE, Inc. (2015). Cleared while this submission was under review Summary page 4.
- K112028: SI-Lok Sacroiliac Joint Fixation System, Globus Medical, Inc. (2011) Summary page 4.

## Most influential descendants
- K160652: iFUSE Implant System (2016), 83 descendants of its own
- K162733: iFuse Implant System® - iFuse-3D implant (2017), 82 descendants of its own
- K182983: iFuse Implant System® (2018), 71 descendants of its own
- K190230: iFuse Implant System® (2019), 57 descendants of its own
- K193524: SI-BONE iFuse Implant System® (2020), 54 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. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life at 12 months post-implantation.

Source page: https://510kreport.com/device/K152681
Methodology: https://510kreport.com/methodology