510(k) · Cleared

Cleared

Modification to SI Joint Fusion System

K092375510(k) SpecialCleared Sep 4, 200930-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

SI-BONE, Inc. · OUR Sacroiliac Joint Fixation

Cleared on Sep 4, 2009 after a 30-day review. The FDA summary names its predicate without a number. 1 of the 256 devices in its family, counting itself, has a Class I recall. 255 later devices descend from it.

Decided: Sep 4, 2009
Review: 30 days
Class: Class II
Product code: OUR
Recalls: None
Predicates: 0

255 later devices descend from it, 14 citing it directly. 1 of the 256 devices in this family, counting this one, has a Class I recall.

This deviceK092375 Modification to SI Joint Fusion SystemSI-BONE, Inc. · 2009
Descendant · cites it directly · 245 of its ownK102907 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010
Descendant · 2 generations on · 241 of its ownK110512 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
Descendant · 3 generations on · 240 of its ownK111801 Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
Descendant · 3 generations on · 238 of its ownK112028 SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc. · 2011
Descendant · cites it directly · 143 of its ownK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011

Showing 5 of 255 descendants. See all descendants

Descendants cleared per year

2010high 40 (2023) · low 1 (2010)2026

Class I recalls in this family

K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 255 · See all

K102907Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010 · cites it directly245descendants
K110512Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011 · 2 generations on241descendants
K111801Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011 · 3 generations on240descendants
K112028SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc. · 2011 · 3 generations on238descendants
K110838Ifuse Implant SystemSI-BONE, Inc. · 2011 · cites it directly143descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K092375	Modification to SI Joint Fusion System	SI-BONE, Inc.	2009	—
+1	K102907	Simmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2010	—
+2	K110512	Simmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2011	—
+3	K111801	Simmetry (TM) Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2011	—
+3	K112028	SI-Lok Sacroiliac Joint Fixation System	Globus Medical, Inc.	2011	—
+1	K110838	Ifuse Implant System	SI-BONE, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2011	4	0
2012	3	0
2013	4	0
2014	3	0
2015	8	0
2016	6	0
2017	6	0
2018	7	0
2019	10	0
2020	10	0
2021	18	1
2022	24	0
2023	40	0
2024	37	0
2025	36	0
2026	38	0

FIG. 1 — Lineage of K092375, 2009–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

1 device in this family has a Class I recall. 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 30.8 · 31 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	—	SI-Bone, Inc.’s SI Joint Fusion System Named without a submission number			—

What descends from it? (255)

See all 255

14 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K102907	Simmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2010	245
K110838	Ifuse Implant System	SI-BONE, Inc.	2011	143
K122074	Ifuse Implant System	SI-BONE, Inc.	2012	139
K123850	Ifuse Implant System	SI-BONE, Inc.	2013	134
K131405	Ifuse Implant System	SI-BONE, Inc.	2013	133
K110472	SI-Fix Sacroiliac Joint Fusion System	Medtronic Sofamor Danek	2012	92
K141049	Ifuse Implant System	SI-BONE, Inc.	2014	88
K150875	iFuse Implant System	SI-BONE, Inc.	2015	86
K150714	SI-BONE iFuse Implant System	SI-BONE, Inc.	2015	86
K151718	iFuse Implant System	SI-BONE, Inc.	2015	85

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K102907 (Zyga Technology, Inc., 2010) has gone furthest, with 245 descendants of its own.

How does its category compare?

All OUR devices

OUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · OUR

14in 2025

2007high 20 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OUR

97in 2025

2007high 168 (2016) · low 27 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OUR

1in 2025

2007high 1 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OUR

10in 2025

2007high 175 (2019) · low 0 (2007)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/K092375 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092375: Modification to SI Joint Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092375

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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