510(k) · Cleared
ClearedOptumSI Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Si Solutions, LLC · OUR Sacroiliac Joint Fixation
Cleared on Nov 20, 2025 as substantially equivalent to K193524 (SI-BONE, Inc., 2020) after a 203-day review. Its family tree reaches back 16 generations to 1993.
- Decided
- Nov 20, 2025
- Review
- 203 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K930834 (1993). 32 ancestors in all, the oldest K903810 (1990). No later device cites it as a predicate yet.
- Root · 16 generations backK930834 AcutractAcu Med, Inc. · 1993
- 12 generations between
- 3 generations backK182983 iFuse Implant System®SI-BONE, Inc. · 2018
- 2 generations backK190230 iFuse Implant System®SI-BONE, Inc. · 2019
- 1 generation backK193524 SI-BONE iFuse Implant System®SI-BONE, Inc. · 2020
- This deviceK251365 OptumSI Implant SystemSi Solutions, LLC · 2025
Show all 16 generations
- Root · 16 generations backK930834 AcutractAcu Med, Inc. · 1993
- 15 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
- 14 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
- 13 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
- 12 generations backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
- 11 generations backK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 10 generations backK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 9 generations backK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
- 8 generations backK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
- 7 generations backK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
- 6 generations backK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
- 5 generations backK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
- 4 generations backK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
- 3 generations backK182983 iFuse Implant System®SI-BONE, Inc. · 2018
- 2 generations backK190230 iFuse Implant System®SI-BONE, Inc. · 2019
- 1 generation backK193524 SI-BONE iFuse Implant System®SI-BONE, Inc. · 2020
- This deviceK251365 OptumSI Implant SystemSi Solutions, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K930834 | Acutract | Acu Med, Inc. | 1993 | — |
| −15 | K051309 | Roi Fusion Rods & Plates | Reiley Orthopaedics, Inc. | 2005 | 2 |
| −14 | K080398 | SI Joint Fusion System | SI-BONE, Inc. | 2008 | — |
| −13 | K110838 | Ifuse Implant System | SI-BONE, Inc. | 2011 | — |
| −12 | K122074 | Ifuse Implant System | SI-BONE, Inc. | 2012 | — |
| −11 | K123850 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −10 | K131405 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −9 | K141049 | Ifuse Implant System | SI-BONE, Inc. | 2014 | — |
| −8 | K150714 | SI-BONE iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −7 | K151718 | iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −6 | K152681 | iFuse Implant System (R) | SI-BONE, Inc. | 2016 | — |
| −5 | K160652 | iFUSE Implant System | SI-BONE, Inc. | 2016 | — |
| −4 | K162733 | iFuse Implant System® - iFuse-3D implant | SI-BONE, Inc. | 2017 | — |
| −3 | K182983 | iFuse Implant System® | SI-BONE, Inc. | 2018 | — |
| −2 | K190230 | iFuse Implant System® | SI-BONE, Inc. | 2019 | — |
| −1 | K193524 | SI-BONE iFuse Implant System® | SI-BONE, Inc. | 2020 | — |
| 0 (this device) | K251365 | OptumSI Implant System | Si Solutions, LLC | 2025 | — |
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 |
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? (1)
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 |
|---|---|---|---|
| * | K193524 | SI-BONE iFuse Implant System®Summary page 5…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K193524 11 SI BONE iFuse Implant System… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 4 of the 32 ancestors have a recall of any class.
- 8 other devices also cite its predicate K193524.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 OptumSI 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251365 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251365: OptumSI Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251365
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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