510(k) · Cleared
ClearedIfuse 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 1, 2013 as substantially equivalent to K080398 (SI-BONE, Inc., 2008) and 3 other predicates after a 108-day review. Its family tree reaches back 5 generations to 1993. 134 later devices descend from it.
- Decided
- Apr 1, 2013
- Review
- 108 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K930834 (1993). 13 ancestors in all, the oldest K903810 (1990). 134 later devices descend from it, 7 citing it directly.
- Root · 5 generations backK930834 AcutractAcu Med, Inc. · 1993
- 4 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
- 3 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
- 2 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
- 1 generation backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
- This deviceK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
- Descendant · cites it directly · 133 of its ownK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
- Descendant · cites it directly · 88 of its ownK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
- Descendant · cites it directly · 86 of its ownK150875 iFuse Implant SystemSI-BONE, Inc. · 2015
- Descendant · cites it directly · 86 of its ownK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
- Descendant · cites it directly · 85 of its ownK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
Showing 5 of 134 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 134 · See all- K131405Ifuse Implant SystemSI-BONE, Inc. · 2013 · cites it directly133descendants
- K141049Ifuse Implant SystemSI-BONE, Inc. · 2014 · cites it directly88descendants
- K150875iFuse Implant SystemSI-BONE, Inc. · 2015 · cites it directly86descendants
- K150714SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015 · cites it directly86descendants
- K151718iFuse Implant SystemSI-BONE, Inc. · 2015 · cites it directly85descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930834 | Acutract | Acu Med, Inc. | 1993 | — |
| −4 | K051309 | Roi Fusion Rods & Plates | Reiley Orthopaedics, Inc. | 2005 | 2 |
| −3 | K080398 | SI Joint Fusion System | SI-BONE, Inc. | 2008 | — |
| −2 | K110838 | Ifuse Implant System | SI-BONE, Inc. | 2011 | — |
| −1 | K122074 | Ifuse Implant System | SI-BONE, Inc. | 2012 | — |
| 0 (this device) | K123850 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| +1 | K131405 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| +1 | K141049 | Ifuse Implant System | SI-BONE, Inc. | 2014 | — |
| +1 | K150875 | iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| +1 | K150714 | SI-BONE iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| +1 | K151718 | iFuse Implant System | SI-BONE, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 11 | 0 |
| 2022 | 16 | 0 |
| 2023 | 24 | 0 |
| 2024 | 21 | 0 |
| 2025 | 19 | 0 |
| 2026 | 17 | 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? (4)
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 1…c Rod Classification Name: 21 C.F.R. 888.3040 - Smooth or threaded metallic bone fastener; Product Code OUR Predicate Devices: SI Joint Fusion System by SI-BONE, Inc. (K080398, K092375, KI1 10838, K122074) Intended Use The iFuse System is intended for sacroiliac joint fusion for conditions including sac… | 2008 |
| * | K092375 | Modification to SI Joint Fusion SystemSummary page 1…assification Name: 21 C.F.R. 888.3040 - Smooth or threaded metallic bone fastener; Product Code OUR Predicate Devices: SI Joint Fusion System by SI-BONE, Inc. (K080398, K092375, KI1 10838, K122074) Intended Use The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac j… | 2009 |
| * | K110838 | Ifuse Implant System | 2011 |
| * | K122074 | Ifuse Implant SystemSummary page 1…1 C.F.R. 888.3040 - Smooth or threaded metallic bone fastener; Product Code OUR Predicate Devices: SI Joint Fusion System by SI-BONE, Inc. (K080398, K092375, KI1 10838, K122074) Intended Use The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and… | 2012 |
What descends from it? (134)
See all 1347 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 20 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K131405 (SI-BONE, Inc., 2013) has gone furthest, with 133 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. 2013, 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 System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123850 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123850: 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/K123850
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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