510(k) · Cleared

Cleared

SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System

K150017510(k) TraditionalCleared Apr 24, 2015109-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

Spinefrontier, Inc. · OUR Sacroiliac Joint Fixation

Cleared on Apr 24, 2015 as substantially equivalent to K122074 (SI-BONE, Inc., 2012) after a 109-day review. Its family tree reaches back 5 generations to 1993. 14 later devices descend from it.

Decided: Apr 24, 2015
Review: 109 days
Class: Class II
Product code: OUR
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K930834 (1993). 13 ancestors in all, the oldest K903810 (1990). 14 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 5 generations backK930834 AcutractAcu Med, Inc. · 1993
4 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
3 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
2 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
1 generation backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
This deviceK150017 SpineFrontier SIJFuse Sacroiliac Joint Fusion Device SystemSpinefrontier, Inc. · 2015
Descendant · cites it directly · 5 of its ownK231689 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2023
Descendant · 2 generations on · 4 of its ownK241574 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2024
Descendant · cites it directly · 3 of its ownK230446 TiLink-L SI Joint Fusion SystemSurGenTec, LLC · 2023
Descendant · cites it directly · 2 of its ownK231829 Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical · 2023
Descendant · 2 generations on · 2 of its ownK231831 TiLink-L Joint Fusion SystemSurgentec · 2023

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2023high 6 (2023) · low 2 (2024)2026

Most influential descendants

Showing 5 of 14 · See all

K231689iFuse TORQ® Implant SystemSI-BONE, Inc. · 2023 · cites it directly5descendants
K241574iFuse TORQ® Implant SystemSI-BONE, Inc. · 2024 · 2 generations on4descendants
K230446TiLink-L SI Joint Fusion SystemSurGenTec, LLC · 2023 · cites it directly3descendants
K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical · 2023 · cites it directly2descendants
K231831TiLink-L Joint Fusion SystemSurgentec · 2023 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K930834	Acutract	Acu Med, Inc.	1993	—
−4	K051309	Roi Fusion Rods & Plates	Reiley Orthopaedics, Inc.	2005	2
−3	K080398	SI Joint Fusion System	SI-BONE, Inc.	2008	—
−2	K110838	Ifuse Implant System	SI-BONE, Inc.	2011	—
−1	K122074	Ifuse Implant System	SI-BONE, Inc.	2012	—
0 (this device)	K150017	SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System	Spinefrontier, Inc.	2015	—
+1	K231689	iFuse TORQ® Implant System	SI-BONE, Inc.	2023	—
+2	K241574	iFuse TORQ® Implant System	SI-BONE, Inc.	2024	—
+1	K230446	TiLink-L SI Joint Fusion System	SurGenTec, LLC	2023	—
+1	K231829	Xenix Medical Sacroiliac Fixation System	Ht Medical D.B.A. Xenix Medical	2023	—
+2	K231831	TiLink-L Joint Fusion System	Surgentec	2023	—

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
2023	6	0
2024	2	0
2025	3	0
2026	3	0

FIG. 1 — Lineage of K150017, 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? (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
*	K122074	Ifuse Implant System Summary page 5 …K150017 - Page 2 of 2 Table 5-1 Predicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer Predicate Type K122074 iFuse Implant System® SI-BONE Primary K021932 6.5mm Cannulated Screw…	SI-BONE, Inc.	2012	—
†	K021932	Synthes 6.5 MM Cannulated Screw	Synthes (Usa)	2002	7

Also cleared against K122074: 8 other devices →

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K231689	iFuse TORQ® Implant System	SI-BONE, Inc.	2023	5
K230446	TiLink-L SI Joint Fusion System	SurGenTec, LLC	2023	3
K231829	Xenix Medical Sacroiliac Fixation System	Ht Medical D.B.A. Xenix Medical	2023	2
K232605	Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…	Lesspine Innovations	2023	0

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 4 companies; a new generation was cleared every 2.5 years on median.
3 of the 13 ancestors have a recall of any class.
Of its descendants, K231689 (SI-BONE, Inc., 2023) has gone furthest, with 5 descendants of its own.
8 other devices also cite its predicate K122074.

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 SIJFuse™ Sacroiliac Joint Fusion Device System is intended for fusion of the sacroiliac joint for conditions including sacroiliac joint disruptions and degenerative sacroilitis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K150017 · printed Nov 5, 2026

Cite this page

510(k) Report. “K150017: SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150017

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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