510(k) · Cleared

Cleared

iFuse Implant System

K150875510(k) TraditionalCleared Jul 22, 2015112-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 Jul 22, 2015 as substantially equivalent to K080398 (SI-BONE, Inc., 2008) and 6 other predicates after a 112-day review. Its family tree reaches back 8 generations to 1993. 86 later devices descend from it.

Decided: Jul 22, 2015
Review: 112 days
Class: Class II
Product code: OUR
Recalls: None
Predicates: 7

Its longest line of descent runs back 8 generations to K930834 (1993). 19 ancestors in all, the oldest K903810 (1990). 86 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 8 generations backK930834 AcutractAcu Med, Inc. · 1993
7 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
6 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
5 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
4 generations backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
3 generations backK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
2 generations backK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
1 generation backK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
This deviceK150875 iFuse Implant SystemSI-BONE, Inc. · 2015
Descendant · cites it directly · 85 of its ownK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
Descendant · cites it directly · 84 of its ownK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
Descendant · cites it directly · 83 of its ownK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
Descendant · 2 generations on · 82 of its ownK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
Descendant · 3 generations on · 71 of its ownK182983 iFuse Implant System®SI-BONE, Inc. · 2018

Showing 5 of 86 descendants. See all descendants

Descendants cleared per year

2015high 14 (2023) · low 1 (2015)2026

Most influential descendants

Showing 5 of 86 · See all

K151718iFuse Implant SystemSI-BONE, Inc. · 2015 · cites it directly85descendants
K152681iFuse Implant System (R)SI-BONE, Inc. · 2016 · cites it directly84descendants
K160652iFUSE Implant SystemSI-BONE, Inc. · 2016 · cites it directly83descendants
K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017 · 2 generations on82descendants
K182983iFuse Implant System®SI-BONE, Inc. · 2018 · 3 generations on71descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K930834	Acutract	Acu Med, Inc.	1993	—
−7	K051309	Roi Fusion Rods & Plates	Reiley Orthopaedics, Inc.	2005	2
−6	K080398	SI Joint Fusion System	SI-BONE, Inc.	2008	—
−5	K110838	Ifuse Implant System	SI-BONE, Inc.	2011	—
−4	K122074	Ifuse Implant System	SI-BONE, Inc.	2012	—
−3	K123850	Ifuse Implant System	SI-BONE, Inc.	2013	—
−2	K131405	Ifuse Implant System	SI-BONE, Inc.	2013	—
−1	K141049	Ifuse Implant System	SI-BONE, Inc.	2014	—
0 (this device)	K150875	iFuse Implant System	SI-BONE, Inc.	2015	—
+1	K151718	iFuse Implant System	SI-BONE, Inc.	2015	—
+1	K152681	iFuse Implant System (R)	SI-BONE, Inc.	2016	—
+1	K160652	iFUSE Implant System	SI-BONE, Inc.	2016	—
+2	K162733	iFuse Implant System® - iFuse-3D implant	SI-BONE, Inc.	2017	—
+3	K182983	iFuse Implant System®	SI-BONE, Inc.	2018	—

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	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2016	2	0
2017	2	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

FIG. 1 — Lineage of K150875, 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

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What was it cleared against? (7)

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 4 …pedic Rod Classification Name: 21 CFR 888.3040 – Smooth or threaded metallic bone fastener; Product Code: OUR Predicate Devices: iFuse Implant System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405 and K141049) Intended Use The iFuse Implant System is intended for sacroiliac fusio…	SI-BONE, Inc.	2008	—
*	K092375	Modification to SI Joint Fusion System Summary page 4 …Classification Name: 21 CFR 888.3040 – Smooth or threaded metallic bone fastener; Product Code: OUR Predicate Devices: iFuse Implant System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405 and K141049) Intended Use The iFuse Implant System is intended for sacroiliac fusion for con…	SI-BONE, Inc.	2009	—
*	K110838	Ifuse Implant System Summary page 4 …ication Name: 21 CFR 888.3040 – Smooth or threaded metallic bone fastener; Product Code: OUR Predicate Devices: iFuse Implant System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405 and K141049) Intended Use The iFuse Implant System is intended for sacroiliac fusion for conditions i…	SI-BONE, Inc.	2011	—
*	K122074	Ifuse Implant System Summary page 4 …ame: 21 CFR 888.3040 – Smooth or threaded metallic bone fastener; Product Code: OUR Predicate Devices: iFuse Implant System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405 and K141049) Intended Use The iFuse Implant System is intended for sacroiliac fusion for conditions including…	SI-BONE, Inc.	2012	—
*	K123850	Ifuse Implant System Summary page 4 …FR 888.3040 – Smooth or threaded metallic bone fastener; Product Code: OUR Predicate Devices: iFuse Implant System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405 and K141049) Intended Use The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroilia…	SI-BONE, Inc.	2013	—
*	K131405	Ifuse Implant System Summary page 4 …40 – Smooth or threaded metallic bone fastener; Product Code: OUR Predicate Devices: iFuse Implant System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405 and K141049) Intended Use The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint d…	SI-BONE, Inc.	2013	—
*	K141049	Ifuse Implant System Summary page 4 …or threaded metallic bone fastener; Product Code: OUR Predicate Devices: iFuse Implant System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405 and K141049) Intended Use The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction t…	SI-BONE, Inc.	2014	—

Also cleared against K080398: 10 other devices →

What descends from it? (86)

See all 86

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

Number	Device	Applicant	Decided	Descendants
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 22 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
4 of the 19 ancestors have a recall of any class.
Of its descendants, K151718 (SI-BONE, Inc., 2015) has gone furthest, with 85 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. 2015, 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 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/K150875 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150875: iFuse 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/K150875

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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