510(k) · Cleared

Cleared

Ifuse Implant System

K110838510(k) SpecialCleared Apr 21, 201127-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 Apr 21, 2011 as substantially equivalent to K080398 (SI-BONE, Inc., 2008) and 1 other predicate after a 27-day review. Its family tree reaches back 3 generations to 1993. 143 later devices descend from it.

Decided: Apr 21, 2011
Review: 27 days
Class: Class II
Product code: OUR
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K930834 (1993). 11 ancestors in all, the oldest K903810 (1990). 143 later devices descend from it, 11 citing it directly.

By dateBy generation

Root · 3 generations backK930834 AcutractAcu Med, Inc. · 1993
2 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
1 generation backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
This deviceK110838 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
Descendant · cites it directly · 88 of its ownK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014

Showing 5 of 143 descendants. See all descendants

Descendants cleared per year

2012high 26 (2023) · low 2 (2012)2026

Most influential descendants

Showing 5 of 143 · See all

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
K141049Ifuse Implant SystemSI-BONE, Inc. · 2014 · cites it directly88descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K930834	Acutract	Acu Med, Inc.	1993	—
−2	K051309	Roi Fusion Rods & Plates	Reiley Orthopaedics, Inc.	2005	2
−1	K080398	SI Joint Fusion System	SI-BONE, Inc.	2008	—
0 (this device)	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	—
+1	K141049	Ifuse Implant System	SI-BONE, Inc.	2014	—

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
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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

FIG. 1 — Lineage of K110838, 1993–2026Source: 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.

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

Get a 510(k) Report

What was it cleared against? (2)

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
*	K080398	SI Joint Fusion System Summary page 1 …ac joint fusion) Classification Name: 21 C.F.R. 888.3040 - Smooth or threaded metallic bone fixation fastener Predicate Devices SI-Bone, Inc's SI Joint Fusion System (K080398; K092375) Intended Use The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disru…	SI-BONE, Inc.	2008	—
*	K092375	Modification to SI Joint Fusion System Summary page 1 …fusion) Classification Name: 21 C.F.R. 888.3040 - Smooth or threaded metallic bone fixation fastener Predicate Devices SI-Bone, Inc's SI Joint Fusion System (K080398; K092375) Intended Use The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions an…	SI-BONE, Inc.	2009	—

Also cleared against K080398: 10 other devices →

What descends from it? (143)

See all 143

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

Number	Device	Applicant	Decided	Descendants
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
K152681	iFuse Implant System (R)	SI-BONE, Inc.	2016	84
K160652	iFUSE Implant System	SI-BONE, Inc.	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 18 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
3 of the 11 ancestors have a recall of any class.
Of its descendants, K122074 (SI-BONE, Inc., 2012) has gone furthest, with 139 descendants of its own.
10 other devices also cite its predicate K080398.

How does its category compare?

All OUR devices

OUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K110838 · printed Nov 5, 2026

Cite this page

510(k) Report. “K110838: Ifuse Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110838

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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