510(k) · Cleared
ClearediFuse Implant System® - iFuse-3D implant
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 Mar 10, 2017 as substantially equivalent to K160652 (SI-BONE, Inc., 2016) after a 162-day review. Its family tree reaches back 12 generations to 1993. 82 later devices descend from it.
- Decided
- Mar 10, 2017
- Review
- 162 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K930834 (1993). 28 ancestors in all, the oldest K903810 (1990). 82 later devices descend from it, 4 citing it directly.
- Root · 12 generations backK930834 AcutractAcu Med, Inc. · 1993
- 8 generations between
- 3 generations backK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
- 2 generations backK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
- 1 generation backK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
- This deviceK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
- Descendant · cites it directly · 71 of its ownK182983 iFuse Implant System®SI-BONE, Inc. · 2018
- Descendant · 2 generations on · 57 of its ownK190230 iFuse Implant System®SI-BONE, Inc. · 2019
- Descendant · 3 generations on · 54 of its ownK193524 SI-BONE iFuse Implant System®SI-BONE, Inc. · 2020
- Descendant · cites it directly · 46 of its ownK172268 iFuse Implant System- iFuse NavigationSI-BONE, Inc. · 2017
- Descendant · 2 generations on · 32 of its ownK220195 iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc. · 2022
Show all 12 generations
- Root · 12 generations backK930834 AcutractAcu Med, Inc. · 1993
- 11 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
- 10 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
- 9 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
- 8 generations backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
- 7 generations backK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 6 generations backK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 5 generations backK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
- 4 generations backK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
- 3 generations backK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
- 2 generations backK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
- 1 generation backK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
- This deviceK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
Showing 5 of 82 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 82 · See all- K182983iFuse Implant System®SI-BONE, Inc. · 2018 · cites it directly71descendants
- K190230iFuse Implant System®SI-BONE, Inc. · 2019 · 2 generations on57descendants
- K193524SI-BONE iFuse Implant System®SI-BONE, Inc. · 2020 · 3 generations on54descendants
- K172268iFuse Implant System- iFuse NavigationSI-BONE, Inc. · 2017 · cites it directly46descendants
- K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc. · 2022 · 2 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K930834 | Acutract | Acu Med, Inc. | 1993 | — |
| −11 | K051309 | Roi Fusion Rods & Plates | Reiley Orthopaedics, Inc. | 2005 | 2 |
| −10 | K080398 | SI Joint Fusion System | SI-BONE, Inc. | 2008 | — |
| −9 | K110838 | Ifuse Implant System | SI-BONE, Inc. | 2011 | — |
| −8 | K122074 | Ifuse Implant System | SI-BONE, Inc. | 2012 | — |
| −7 | K123850 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −6 | K131405 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −5 | K141049 | Ifuse Implant System | SI-BONE, Inc. | 2014 | — |
| −4 | K150714 | SI-BONE iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −3 | K151718 | iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −2 | K152681 | iFuse Implant System (R) | SI-BONE, Inc. | 2016 | — |
| −1 | K160652 | iFUSE Implant System | SI-BONE, Inc. | 2016 | — |
| 0 (this device) | K162733 | iFuse Implant System® - iFuse-3D implant | SI-BONE, Inc. | 2017 | — |
| +1 | K182983 | iFuse Implant System® | SI-BONE, Inc. | 2018 | — |
| +2 | K190230 | iFuse Implant System® | SI-BONE, Inc. | 2019 | — |
| +3 | K193524 | SI-BONE iFuse Implant System® | SI-BONE, Inc. | 2020 | — |
| +1 | K172268 | iFuse Implant System- iFuse Navigation | SI-BONE, Inc. | 2017 | — |
| +2 | K220195 | iFuse Bedrock Granite™ Implant System | SI-BONE, Inc. | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 7 | 0 |
| 2022 | 12 | 0 |
| 2023 | 14 | 0 |
| 2024 | 11 | 0 |
| 2025 | 14 | 0 |
| 2026 | 13 | 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 |
|---|---|---|---|
| * | K160652 | iFUSE Implant SystemSummary page 4…stener Product Code: OUR; Sacroiliac Joint Fixation III. PREDICATE DEVICES Primary Predicate: iFuse Implant System by SI-BONE, K160652 Reference Predicate: Synthes Cannulated Screw, K021932 Spine Frontier, K150017 IV.… | 2016 |
| † | K021932 | Synthes 6.5 MM Cannulated Screw | 2002 |
| † | K150017 | SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System | 2015 |
What descends from it? (82)
See all 824 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 24 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 4 of the 28 ancestors have a recall of any class.
- Of its descendants, K182983 (SI-BONE, Inc., 2018) has gone furthest, with 71 descendants 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. 2017, 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 Implant System is intended for sacroiliac fusion for conditions including 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/K162733 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162733: iFuse Implant System® - iFuse-3D implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162733
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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