510(k) · Cleared
ClearedSI-Cure Sacroiliac Joint Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alevio, LLC · OUR Sacroiliac Joint Fixation
Cleared on Jan 18, 2023 as substantially equivalent to K141106 (Folsom Metal Products, Inc. Dba Frontier Devices, 2014) and 1 other predicate after a 28-day review. Its family tree reaches back 18 generations to 1993. 2 later devices descend from it.
- Decided
- Jan 18, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K930834 (1993). 140 ancestors in all, the oldest K841189 (1984). 2 later devices descend from it, 1 citing it directly.
- Root · 18 generations backK930834 AcutractAcu Med, Inc. · 1993
- 14 generations between
- 3 generations backK193524 SI-BONE iFuse Implant System®SI-BONE, Inc. · 2020
- 2 generations backK201538 Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc. · 2020
- 1 generation backK212903 SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc. · 2021
- This deviceK223819 SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC · 2023
- Descendant · cites it directly · 1 of its ownK231951 SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK230226 Integrity-SI® Fusion SystemOsteoCentric Technologies · 2023
Show all 18 generations
- Root · 18 generations backK930834 AcutractAcu Med, Inc. · 1993
- 17 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
- 16 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
- 15 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
- 14 generations backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
- 13 generations backK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 12 generations backK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 11 generations backK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
- 10 generations backK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
- 9 generations backK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
- 8 generations backK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
- 7 generations backK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
- 6 generations backK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
- 5 generations backK182983 iFuse Implant System®SI-BONE, Inc. · 2018
- 4 generations backK190230 iFuse Implant System®SI-BONE, Inc. · 2019
- 3 generations backK193524 SI-BONE iFuse Implant System®SI-BONE, Inc. · 2020
- 2 generations backK201538 Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc. · 2020
- 1 generation backK212903 SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc. · 2021
- This deviceK223819 SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K930834 | Acutract | Acu Med, Inc. | 1993 | — |
| −17 | K051309 | Roi Fusion Rods & Plates | Reiley Orthopaedics, Inc. | 2005 | 2 |
| −16 | K080398 | SI Joint Fusion System | SI-BONE, Inc. | 2008 | — |
| −15 | K110838 | Ifuse Implant System | SI-BONE, Inc. | 2011 | — |
| −14 | K122074 | Ifuse Implant System | SI-BONE, Inc. | 2012 | — |
| −13 | K123850 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −12 | K131405 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −11 | K141049 | Ifuse Implant System | SI-BONE, Inc. | 2014 | — |
| −10 | K150714 | SI-BONE iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −9 | K151718 | iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −8 | K152681 | iFuse Implant System (R) | SI-BONE, Inc. | 2016 | — |
| −7 | K160652 | iFUSE Implant System | SI-BONE, Inc. | 2016 | — |
| −6 | K162733 | iFuse Implant System® - iFuse-3D implant | SI-BONE, Inc. | 2017 | — |
| −5 | K182983 | iFuse Implant System® | SI-BONE, Inc. | 2018 | — |
| −4 | K190230 | iFuse Implant System® | SI-BONE, Inc. | 2019 | — |
| −3 | K193524 | SI-BONE iFuse Implant System® | SI-BONE, Inc. | 2020 | — |
| −2 | K201538 | Life Spine SIMPACT Sacroiliac Joint Fixation System | Life Spine, Inc. | 2020 | — |
| −1 | K212903 | SIMPACT Sacroiliac Joint Fixation System | Life Spine, Inc. | 2021 | — |
| 0 (this device) | K223819 | SI-Cure Sacroiliac Joint Fusion System | Alevio, LLC | 2023 | — |
| +1 | K231951 | SI-Cure Sacroiliac Joint Fusion System | Alevio, LLC | 2023 | — |
| +2 | K230226 | Integrity-SI® Fusion System | OsteoCentric Technologies | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 8 | 0 |
| 1996 | 4 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 9 | 0 |
| 2002 | 8 | 0 |
| 2003 | 6 | 0 |
| 2004 | 8 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K141106 | Frontier Devices Fusio Screw Fuze SystemSummary page 5…cturer Predicate Number Type K141106 Frontier Devices FUSIO Screw Fuze System Folsom Metal Products, Inc. DBA Frontier Devices Primary K212903 SIMPAC… | 2014 |
| * | K212903 | SIMPACT Sacroiliac Joint Fixation SystemSummary page 5…Type K141106 Frontier Devices FUSIO Screw Fuze System Folsom Metal Products, Inc. DBA Frontier Devices Primary K212903 SIMPACT Sacroiliac Joint Fixation System Life Spine, Inc. Additional PERFORMANCE DATA… | 2021 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231951 | SI-Cure Sacroiliac Joint Fusion System | 2023 | 1 |
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 30 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 19 of the 140 ancestors have a recall of any class.
- Of its descendants, K231951 (Alevio, LLC, 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 SI-Cure Sacroiliac Joint Fusion 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 acropelvic 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/K223819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223819: SI-Cure Sacroiliac Joint Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223819
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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