510(k) · Cleared
ClearediFuse INTRA Ti™ 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 Feb 11, 2026 as substantially equivalent to K180818 (Tenon Medical, Inc., 2018) and 4 other predicates after a 110-day review. Its family tree reaches back 23 generations to 1993.
- Decided
- Feb 11, 2026
- Review
- 110 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 23 generations to K930834 (1993). 307 ancestors in all, the oldest K792022 (1979). 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 backK231689 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2023
- 1 generation backK241574 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2024
- This deviceK253488 iFuse INTRA Ti™ Implant SystemSI-BONE, Inc. · 2026
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 backK231689 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2023
- 1 generation backK241574 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2024
- This deviceK253488 iFuse INTRA Ti™ Implant SystemSI-BONE, Inc. · 2026
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 | K231689 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2023 | — |
| −1 | K241574 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2024 | — |
| 0 (this device) | K253488 | iFuse INTRA Ti™ Implant System | SI-BONE, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 4 | 0 |
| 1991 | 2 | 0 |
| 1992 | 8 | 0 |
| 1993 | 4 | 0 |
| 1994 | 11 | 0 |
| 1995 | 13 | 0 |
| 1996 | 14 | 0 |
| 1997 | 9 | 0 |
| 1998 | 11 | 0 |
| 1999 | 10 | 0 |
| 2000 | 18 | 0 |
| 2001 | 20 | 0 |
| 2002 | 15 | 0 |
| 2003 | 20 | 0 |
| 2004 | 16 | 0 |
| 2005 | 19 | 0 |
| 2006 | 12 | 0 |
| 2007 | 6 | 0 |
| 2008 | 8 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 8 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 1 | 0 |
| 2015 | 6 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 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? (5)
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 |
|---|---|---|---|
| * | K180818 | Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Summary page 5…Manufacturer 510(k)# Clearance Date Catamaran Sacroiliac Joint Tenon Medical K180818 13 June 2018 Fixation System Additional Predicates: Predicate Device… | 2018 |
| * | K203247 | iFuse-TORQ™ Implant SystemSummary page 5…Predicate Device Manufacturer 510(k)# Clearance Date K203247 4 March 2021 iFuse TORQ Implant System SI-BONE, Inc.… | 2021 |
| * | K241574 | iFuse TORQ® Implant SystemSummary page 5…K203247 4 March 2021 iFuse TORQ Implant System SI-BONE, Inc. K241574 2 July 2024 DePuy Synthes 6.5 mm Synthes USA Products… | 2024 |
| * | K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Summary page 5…K241574 2 July 2024 DePuy Synthes 6.5 mm Synthes USA Products K161616 16 February 2017 Cannulated Screws iFuse 3D Implant System SI-BONE, Inc.… | 2017 |
| * | K162733 | iFuse Implant System® - iFuse-3D implantSummary page 5…Synthes USA Products K161616 16 February 2017 Cannulated Screws iFuse 3D Implant System SI-BONE, Inc. K162733 10 March 2017… | 2017 |
| † | K161210 | RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)… | 2016 |
| † | K233508 | iFuse Bedrock Granite® Implant System | 2024 |
| † | K220195 | iFuse Bedrock Granite™ Implant System | 2022 |
| † | K241504 | iFuse TORQ TNT™ Implant System | 2024 |
| † | K251780 | iGPS Navigation Instruments | 2025 |
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 33 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 47 of the 307 ancestors have a recall of any class.
- 10 other devices also cite its predicate K180818.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 INTRA Ti Implant System is intended for fusion of the sacroiliac joint for 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253488 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253488: iFuse INTRA Ti™ 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/K253488
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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