510(k) · Cleared
ClearedSI-BONE iFuse Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SI-BONE, Inc. · OUR Sacroiliac Joint Fixation
Cleared on Apr 17, 2015 as substantially equivalent to K080398 (SI-BONE, Inc., 2008) and 6 other predicates after a 29-day review. Its family tree reaches back 8 generations to 1993. 86 later devices descend from it.
- Decided
- Apr 17, 2015
- Review
- 29 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 8 generations to K930834 (1993). 19 ancestors in all, the oldest K903810 (1990). 86 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK930834 AcutractAcu Med, Inc. · 1993
- 7 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
- 6 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
- 5 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
- 4 generations backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
- 3 generations backK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 2 generations backK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 1 generation backK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
- This deviceK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
- Descendant · cites it directly · 85 of its ownK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
- Descendant · cites it directly · 84 of its ownK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
- Descendant · cites it directly · 83 of its ownK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
- Descendant · 2 generations on · 82 of its ownK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
- Descendant · 3 generations on · 71 of its ownK182983 iFuse Implant System®SI-BONE, Inc. · 2018
Showing 5 of 86 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 86 · See all- K151718iFuse Implant SystemSI-BONE, Inc. · 2015 · cites it directly85descendants
- K152681iFuse Implant System (R)SI-BONE, Inc. · 2016 · cites it directly84descendants
- K160652iFUSE Implant SystemSI-BONE, Inc. · 2016 · cites it directly83descendants
- K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017 · 2 generations on82descendants
- K182983iFuse Implant System®SI-BONE, Inc. · 2018 · 3 generations on71descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K930834 | Acutract | Acu Med, Inc. | 1993 | — |
| −7 | K051309 | Roi Fusion Rods & Plates | Reiley Orthopaedics, Inc. | 2005 | 2 |
| −6 | K080398 | SI Joint Fusion System | SI-BONE, Inc. | 2008 | — |
| −5 | K110838 | Ifuse Implant System | SI-BONE, Inc. | 2011 | — |
| −4 | K122074 | Ifuse Implant System | SI-BONE, Inc. | 2012 | — |
| −3 | K123850 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −2 | K131405 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −1 | K141049 | Ifuse Implant System | SI-BONE, Inc. | 2014 | — |
| 0 (this device) | K150714 | SI-BONE iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| +1 | K151718 | iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| +1 | K152681 | iFuse Implant System (R) | SI-BONE, Inc. | 2016 | — |
| +1 | K160652 | iFUSE Implant System | SI-BONE, Inc. | 2016 | — |
| +2 | K162733 | iFuse Implant System® - iFuse-3D implant | SI-BONE, Inc. | 2017 | — |
| +3 | K182983 | iFuse Implant System® | SI-BONE, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 7 | 0 |
| 2022 | 12 | 0 |
| 2023 | 14 | 0 |
| 2024 | 11 | 0 |
| 2025 | 14 | 0 |
| 2026 | 13 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OUR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OUR device
- #1 K233508 iFuse Bedrock Granite® Implant Systemscore 30.7 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080398 | SI Joint Fusion SystemSummary page 4…ssification Name: 21 C.F.R. 888.3040 – Smooth or threaded metallic bone fixation fastener Product Code: OUR Predicate Devices: SI Joint Fusion System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405, K141049). Intended Use The iFuse Implant System is intended for sacroiliac joint f… | 2008 |
| * | K092375 | Modification to SI Joint Fusion SystemSummary page 4…on Name: 21 C.F.R. 888.3040 – Smooth or threaded metallic bone fixation fastener Product Code: OUR Predicate Devices: SI Joint Fusion System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405, K141049). Intended Use The iFuse Implant System is intended for sacroiliac joint fusion for… | 2009 |
| * | K110838 | Ifuse Implant SystemSummary page 4…21 C.F.R. 888.3040 – Smooth or threaded metallic bone fixation fastener Product Code: OUR Predicate Devices: SI Joint Fusion System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405, K141049). Intended Use The iFuse Implant System is intended for sacroiliac joint fusion for conditio… | 2011 |
| * | K122074 | Ifuse Implant SystemSummary page 4…888.3040 – Smooth or threaded metallic bone fixation fastener Product Code: OUR Predicate Devices: SI Joint Fusion System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405, K141049). Intended Use The iFuse Implant System is intended for sacroiliac joint fusion for conditions includ… | 2012 |
| * | K123850 | Ifuse Implant SystemSummary page 4…– Smooth or threaded metallic bone fixation fastener Product Code: OUR Predicate Devices: SI Joint Fusion System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405, K141049). Intended Use The iFuse Implant System is intended for sacroiliac joint fusion for conditions including sacro… | 2013 |
| * | K131405 | Ifuse Implant SystemSummary page 4…or threaded metallic bone fixation fastener Product Code: OUR Predicate Devices: SI Joint Fusion System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405, K141049). Intended Use The iFuse Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joi… | 2013 |
| * | K141049 | Ifuse Implant SystemSummary page 4…ded metallic bone fixation fastener Product Code: OUR Predicate Devices: SI Joint Fusion System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405, K141049). Intended Use The iFuse Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint dysfun… | 2014 |
What descends from it? (86)
See all 863 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 19 ancestors have a recall of any class.
- Of its descendants, K151718 (SI-BONE, Inc., 2015) has gone furthest, with 85 descendants of its own.
- 10 other devices also cite its predicate K080398.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OUR
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OUR
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OUR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OUR
10in 2025
MAUDE reports naming product code OUR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 3 | 27 | 0 | 6 |
| 2012 | 2 | — | 0 | 81 |
| 2013 | 4 | 103 | 0 | 96 |
| 2014 | 3 | 91 | 0 | 146 |
| 2015 | 8 | 111 | 0 | 119 |
| 2016 | 6 | 168 | 0 | 122 |
| 2017 | 4 | 120 | 0 | 157 |
| 2018 | 7 | 82 | 0 | 137 |
| 2019 | 7 | 89 | 0 | 175 |
| 2020 | 7 | 88 | 0 | 148 |
| 2021 | 9 | 85 | 0 | 154 |
| 2022 | 14 | 149 | 0 | 23 |
| 2023 | 20 | 55 | 0 | 7 |
| 2024 | 15 | 74 | 0 | 15 |
| 2025 | 14 | 97 | 1 | 10 |
| 2026 | 6 | 98 | 1 | — |
What is it indicated for?
The iFuse Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruptions and degenerative sacroiliitis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150714 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150714: SI-BONE iFuse Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150714
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026