510(k) · Cleared
ClearedSI Joint Fusion 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 Nov 26, 2008 as substantially equivalent to K021932 (Synthes (Usa), 2002) and 2 other predicates after a 287-day review. Its family tree reaches back 2 generations to 1993. 144 later devices descend from it.
- Decided
- Nov 26, 2008
- Review
- 287 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K930834 (1993). 9 ancestors in all, the oldest K903810 (1990). 144 later devices descend from it, 11 citing it directly.
- Root · 2 generations backK930834 AcutractAcu Med, Inc. · 1993
- 1 generation backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
- This deviceK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
- Descendant · cites it directly · 143 of its ownK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
- Descendant · cites it directly · 139 of its ownK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
- Descendant · cites it directly · 134 of its ownK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
- Descendant · cites it directly · 133 of its ownK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
- Descendant · cites it directly · 92 of its ownK110472 SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek · 2012
Showing 5 of 144 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 144 · See all- K110838Ifuse Implant SystemSI-BONE, Inc. · 2011 · cites it directly143descendants
- K122074Ifuse Implant SystemSI-BONE, Inc. · 2012 · cites it directly139descendants
- K123850Ifuse Implant SystemSI-BONE, Inc. · 2013 · cites it directly134descendants
- K131405Ifuse Implant SystemSI-BONE, Inc. · 2013 · cites it directly133descendants
- K110472SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek · 2012 · cites it directly92descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930834 | Acutract | Acu Med, Inc. | 1993 | — |
| −1 | K051309 | Roi Fusion Rods & Plates | Reiley Orthopaedics, Inc. | 2005 | 2 |
| 0 (this device) | K080398 | SI Joint Fusion System | SI-BONE, Inc. | 2008 | — |
| +1 | K110838 | Ifuse Implant System | SI-BONE, Inc. | 2011 | — |
| +1 | K122074 | Ifuse Implant System | SI-BONE, Inc. | 2012 | — |
| +1 | K123850 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| +1 | K131405 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| +1 | K110472 | SI-Fix Sacroiliac Joint Fusion System | Medtronic Sofamor Danek | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 11 | 0 |
| 2022 | 16 | 0 |
| 2023 | 26 | 0 |
| 2024 | 21 | 0 |
| 2025 | 19 | 0 |
| 2026 | 18 | 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 |
|---|---|---|---|
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 1…sual Name: Orthopedic Rods Classification Name: 21 CFR 888.3040 - Smooth or threaded metallic bone fastener Predicate Devices: Synthes (USA) 6.5 mm Cannulated Screw (K021932) Reiley Orthopedics ROI Fusion Rods and Plates (K051309) SIJF Cannulated Screw System (K051296) Intended Use: The SI-Bone St… | 2002 |
| * | K051309 | Roi Fusion Rods & PlatesSummary page 1…888.3040 - Smooth or threaded metallic bone fastener Predicate Devices: Synthes (USA) 6.5 mm Cannulated Screw (K021932) Reiley Orthopedics ROI Fusion Rods and Plates (K051309) SIJF Cannulated Screw System (K051296) Intended Use: The SI-Bone St Joint Fusion system is intended for fracture fixation of… | 2005 |
| * | K051296 | Sijf Cannulated Screw SystemSummary page 1…one fastener Predicate Devices: Synthes (USA) 6.5 mm Cannulated Screw (K021932) Reiley Orthopedics ROI Fusion Rods and Plates (K051309) SIJF Cannulated Screw System (K051296) Intended Use: The SI-Bone St Joint Fusion system is intended for fracture fixation of large bones and large bone fragments of… | 2005 |
What descends from it? (144)
See all 14411 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110838 | Ifuse Implant System | 2011 | 143 |
| K122074 | Ifuse Implant System | 2012 | 139 |
| K123850 | Ifuse Implant System | 2013 | 134 |
| K131405 | Ifuse Implant System | 2013 | 133 |
| K110472 | SI-Fix Sacroiliac Joint Fusion System | 2012 | 92 |
| K141049 | Ifuse Implant System | 2014 | 88 |
| K150875 | iFuse Implant System | 2015 | 86 |
| K150714 | SI-BONE iFuse Implant System | 2015 | 86 |
| K151718 | iFuse Implant System | 2015 | 85 |
| K160652 | iFUSE Implant System | 2016 | 83 |
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 15 years and passes through 3 companies; a new generation was cleared every 12.0 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K110838 (SI-BONE, Inc., 2011) has gone furthest, with 143 descendants of its own.
- 61 other devices also cite its predicate K021932.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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-Bone Si Joint Fusion system is intended for fracture fixation of large bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
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/K080398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080398: SI 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/K080398
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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