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 Mar 31, 2020 as substantially equivalent to K190230 (SI-BONE, Inc., 2019) and 2 other predicates after a 103-day review. Its family tree reaches back 15 generations to 1993. 54 later devices descend from it.
- Decided
- Mar 31, 2020
- Review
- 103 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K930834 (1993). 31 ancestors in all, the oldest K903810 (1990). 54 later devices descend from it, 9 citing it directly.
- Root · 15 generations backK930834 AcutractAcu Med, Inc. · 1993
- 11 generations between
- 3 generations backK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
- 2 generations backK182983 iFuse Implant System®SI-BONE, Inc. · 2018
- 1 generation backK190230 iFuse Implant System®SI-BONE, Inc. · 2019
- This deviceK193524 SI-BONE iFuse Implant System®SI-BONE, Inc. · 2020
- Descendant · cites it directly · 32 of its ownK220195 iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc. · 2022
- Descendant · 2 generations on · 20 of its ownK222774 iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2022
- Descendant · cites it directly · 17 of its ownK203247 iFuse-TORQ™ Implant SystemSI-BONE, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 15 of its ownK213667 iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022
- Descendant · 2 generations on · 14 of its ownK222605 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022
Show all 15 generations
- Root · 15 generations backK930834 AcutractAcu Med, Inc. · 1993
- 14 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
- 13 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
- 12 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
- 11 generations backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
- 10 generations backK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 9 generations backK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 8 generations backK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
- 7 generations backK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
- 6 generations backK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
- 5 generations backK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
- 4 generations backK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
- 3 generations backK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
- 2 generations backK182983 iFuse Implant System®SI-BONE, Inc. · 2018
- 1 generation backK190230 iFuse Implant System®SI-BONE, Inc. · 2019
- This deviceK193524 SI-BONE iFuse Implant System®SI-BONE, Inc. · 2020
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc. · 2022 · cites it directly32descendants
- K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2022 · 2 generations on20descendants
- K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc. · 2021 · cites it directly17descendants
- K213667iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022 · 2 generations on15descendants
- K222605iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022 · 2 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K930834 | Acutract | Acu Med, Inc. | 1993 | — |
| −14 | K051309 | Roi Fusion Rods & Plates | Reiley Orthopaedics, Inc. | 2005 | 2 |
| −13 | K080398 | SI Joint Fusion System | SI-BONE, Inc. | 2008 | — |
| −12 | K110838 | Ifuse Implant System | SI-BONE, Inc. | 2011 | — |
| −11 | K122074 | Ifuse Implant System | SI-BONE, Inc. | 2012 | — |
| −10 | K123850 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −9 | K131405 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −8 | K141049 | Ifuse Implant System | SI-BONE, Inc. | 2014 | — |
| −7 | K150714 | SI-BONE iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −6 | K151718 | iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −5 | K152681 | iFuse Implant System (R) | SI-BONE, Inc. | 2016 | — |
| −4 | K160652 | iFUSE Implant System | SI-BONE, Inc. | 2016 | — |
| −3 | K162733 | iFuse Implant System® - iFuse-3D implant | SI-BONE, Inc. | 2017 | — |
| −2 | K182983 | iFuse Implant System® | SI-BONE, Inc. | 2018 | — |
| −1 | K190230 | iFuse Implant System® | SI-BONE, Inc. | 2019 | — |
| 0 (this device) | K193524 | SI-BONE iFuse Implant System® | SI-BONE, Inc. | 2020 | — |
| +1 | K220195 | iFuse Bedrock Granite™ Implant System | SI-BONE, Inc. | 2022 | — |
| +2 | K222774 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | 2022 | — |
| +1 | K203247 | iFuse-TORQ™ Implant System | SI-BONE, Inc. | 2021 | 1 |
| +2 | K213667 | iFuse-TORQ® Implant System | SI-BONE, Inc. | 2022 | — |
| +2 | K222605 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2022 | — |
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 | 2 | 0 |
| 2011 | 3 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 6 | 0 |
| 2023 | 10 | 0 |
| 2024 | 9 | 0 |
| 2025 | 12 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K190230 | iFuse Implant System®Summary page 4…88.3040, Smooth or threaded metallic bone fastener Product Code: OUR IV. PREDICATE DEVICE SI-BONE iFuse Implant System® K190230 (Primary Predicate) SI-BONE iFuse Implant System® K110838, K092375, K080298 (Reference Predicates) V. D… | 2019 |
| * | K110838 | Ifuse Implant SystemSummary page 4…OUR IV. PREDICATE DEVICE SI-BONE iFuse Implant System® K190230 (Primary Predicate) SI-BONE iFuse Implant System® K110838, K092375, K080298 (Reference Predicates) V. DEVICE DESCRIPTION The iFuse Implant System consists of cannulated tria… | 2011 |
| * | K092375 | Modification to SI Joint Fusion SystemSummary page 4…OUR IV. PREDICATE DEVICE SI-BONE iFuse Implant System® K190230 (Primary Predicate) SI-BONE iFuse Implant System® K110838, K092375, K080298 (Reference Predicates) V. DEVICE DESCRIPTION The iFuse Implant System consists of cannulated triangular, t… | 2009 |
| Kept off the family tree | K080298 | FDA’s K080298 is Dermabiosafe Our reading of the summary gave K080298, FDA’s number for Dermabiosafe (Complete Product Resources). Its FDA name has none of the distinctive words the summary uses for the device it names, “SI-BONE iFuse Implant System®”. Kept off the family tree. Summary page 4…IV. PREDICATE DEVICE SI-BONE iFuse Implant System® K190230 (Primary Predicate) SI-BONE iFuse Implant System® K110838, K092375, K080298 (Reference Predicates) V. DEVICE DESCRIPTION The iFuse Implant System consists of cannulated triangular, titanium i… | 2008 |
What descends from it? (54)
See all 549 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220195 | iFuse Bedrock Granite™ Implant System | 2022 | 32 |
| K203247 | iFuse-TORQ™ Implant System | 2021 | 17 |
| K201538 | Life Spine SIMPACT Sacroiliac Joint Fixation System | 2020 | 13 |
| K250403 | Catamaran SI Joint Fusion System | 2025 | 1 |
| K222512 | Integrity-SI Fusion System | 2022 | 1 |
| K251365 | OptumSI Implant System | 2025 | 0 |
| K243838 | NEXXT MATRIXX® SI System | 2025 | 0 |
| K230817 | TORPEDO Implant System® | 2024 | 0 |
| K212962 | TRELLIS™ SI Joint Fusion System | 2022 | 0 |
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 27 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 4 of the 31 ancestors have a recall of any class.
- Of its descendants, K220195 (SI-BONE, Inc., 2022) has gone furthest, with 32 descendants of its own.
- 2 other devices also cite its predicate K190230.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 fusion for the following conditions:
• 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.
• To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
• Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193524: 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/K193524
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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