510(k) · Cleared
ClearedEminent Spine Posterior SI System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eminent Spine · OUR Sacroiliac Joint Fixation
Cleared on Oct 7, 2025 as substantially equivalent to K190580 (Ilion Medical, Inc., 2020) and 2 other predicates after a 196-day review. Its family tree reaches back 23 generations to 1993.
- Decided
- Oct 7, 2025
- Review
- 196 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 23 generations to K930834 (1993). 227 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.
- Root · 23 generations backK930834 AcutractAcu Med, Inc. · 1993
- 19 generations between
- 3 generations backK222605 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022
- 2 generations backK223708 Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC · 2023
- 1 generation backK240505 Eminent Spine SI Screw SystemEminent Spine, LLC · 2024
- This deviceK250894 Eminent Spine Posterior SI SystemEminent Spine · 2025
Show all 23 generations
- Root · 23 generations backK930834 AcutractAcu Med, Inc. · 1993
- 22 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
- 21 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
- 20 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
- 19 generations backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
- 18 generations backK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 17 generations backK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 16 generations backK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
- 15 generations backK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
- 14 generations backK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
- 13 generations backK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
- 12 generations backK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
- 11 generations backK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
- 10 generations backK182983 iFuse Implant System®SI-BONE, Inc. · 2018
- 9 generations backK183342 SambaScrew 3D SI Fusion SystemOrthofix, Inc. · 2019
- 8 generations backK200696 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · Recalled
- 7 generations backK201664 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
- 6 generations backK203138 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
- 5 generations backK210667 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2021
- 4 generations backK213667 iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022
- 3 generations backK222605 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022
- 2 generations backK223708 Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC · 2023
- 1 generation backK240505 Eminent Spine SI Screw SystemEminent Spine, LLC · 2024
- This deviceK250894 Eminent Spine Posterior SI SystemEminent Spine · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K930834 | Acutract | Acu Med, Inc. | 1993 | — |
| −22 | K051309 | Roi Fusion Rods & Plates | Reiley Orthopaedics, Inc. | 2005 | 2 |
| −21 | K080398 | SI Joint Fusion System | SI-BONE, Inc. | 2008 | — |
| −20 | K110838 | Ifuse Implant System | SI-BONE, Inc. | 2011 | — |
| −19 | K122074 | Ifuse Implant System | SI-BONE, Inc. | 2012 | — |
| −18 | K123850 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −17 | K131405 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −16 | K141049 | Ifuse Implant System | SI-BONE, Inc. | 2014 | — |
| −15 | K150714 | SI-BONE iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −14 | K151718 | iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −13 | K152681 | iFuse Implant System (R) | SI-BONE, Inc. | 2016 | — |
| −12 | K160652 | iFUSE Implant System | SI-BONE, Inc. | 2016 | — |
| −11 | K162733 | iFuse Implant System® - iFuse-3D implant | SI-BONE, Inc. | 2017 | — |
| −10 | K182983 | iFuse Implant System® | SI-BONE, Inc. | 2018 | — |
| −9 | K183342 | SambaScrew 3D SI Fusion System | Orthofix, Inc. | 2019 | — |
| −8 | K200696 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | 1 |
| −7 | K201664 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | — |
| −6 | K203138 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | — |
| −5 | K210667 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2021 | — |
| −4 | K213667 | iFuse-TORQ® Implant System | SI-BONE, Inc. | 2022 | — |
| −3 | K222605 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2022 | — |
| −2 | K223708 | Entasis 3D Dual-Lead Sacroiliac Implant System | Corelink, LLC | 2023 | — |
| −1 | K240505 | Eminent Spine SI Screw System | Eminent Spine, LLC | 2024 | — |
| 0 (this device) | K250894 | Eminent Spine Posterior SI System | Eminent Spine | 2025 | — |
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 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 7 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 11 | 0 |
| 1996 | 5 | 0 |
| 1997 | 8 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 10 | 0 |
| 2001 | 11 | 0 |
| 2002 | 11 | 0 |
| 2003 | 13 | 0 |
| 2004 | 12 | 0 |
| 2005 | 13 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K190580 | NADIA SI Fusion SystemSummary page 5…Class II Reviewing Panel: Product Orthopedic Code: OUR Primary Predicate: Ilion Medical NADIA SI Fusion System (K190580) Additional Predicate: Omnia Medical PsiF DNA™ System (K242431) Additional Predicate: Eminent Spine SI Scre… | 2020 |
| * | K242431 | Omnia Medical PsiF DNA™ System Cleared while this submission was under review Summary page 5…OUR Primary Predicate: Ilion Medical NADIA SI Fusion System (K190580) Additional Predicate: Omnia Medical PsiF DNA™ System (K242431) Additional Predicate: Eminent Spine SI Screw System (K240505) Reference Device: Synthes 6.5mm Cannulat… | 2025 |
| * | K240505 | Eminent Spine SI Screw SystemSummary page 5…ADIA SI Fusion System (K190580) Additional Predicate: Omnia Medical PsiF DNA™ System (K242431) Additional Predicate: Eminent Spine SI Screw System (K240505) Reference Device: Synthes 6.5mm Cannulated Screw (K021932) Device Description: The Eminent Spine Posterior SI S… | 2024 |
| † | K021932 | Synthes 6.5 MM Cannulated Screw | 2002 |
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 7 companies; a new generation was cleared every 9 months on median.
- 30 of the 227 ancestors have a recall of any class.
- 1 other device also cites its predicate K190580.
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 Eminent Spine Posterior SI System is intended for sacroiliac joint fusion for conditions including degenerative sacroiliitis and sacroiliac joint disruptions, to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. This includes those whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250894 · printed Nov 5, 2026
Cite this page
510(k) Report. “K250894: Eminent Spine Posterior SI System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K250894
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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