510(k) Report

510(k) · Cleared

Cleared

Ifuse Implant System

K131405510(k) TraditionalCleared Oct 16, 2013154-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 Oct 16, 2013 as substantially equivalent to K080398 (SI-BONE, Inc., 2008) and 5 other predicates after a 154-day review. Its family tree reaches back 6 generations to 1993. 133 later devices descend from it.

Decided
Oct 16, 2013
Review
154 days
Class
Class II
Product code
OUR
Recalls
None
Predicates
6

Its longest line of descent runs back 6 generations to K930834 (1993). 17 ancestors in all, the oldest K903810 (1990). 133 later devices descend from it, 10 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2009: 1 other ancestor2005: 1 other ancestor2002: 2 other ancestors2001: 2 other ancestors1996: 1 other ancestor2000: 1 other ancestor1995: 1 other ancestor1990: 1 other ancestor2015: 3 descendants cleared2018: 2 descendants cleared2016: 4 descendants cleared2014: 2 descendants cleared2017: 2 descendants cleared2019: 5 descendants cleared2023: 24 descendants cleared2026: 17 descendants cleared2025: 19 descendants cleared2021: 11 descendants cleared2024: 21 descendants cleared2020: 7 descendants cleared2022: 16 descendants clearedK930834 · Acutract · Acu Med, Inc. · 1993K051309 · Roi Fusion Rods & Plates · Reiley Orthopaedics, Inc. · 2005 · recalledK080398 · SI Joint Fusion System · SI-BONE, Inc. · 2008K110838 · Ifuse Implant System · SI-BONE, Inc. · 2011K122074 · Ifuse Implant System · SI-BONE, Inc. · 2012K123850 · Ifuse Implant System · SI-BONE, Inc. · 20131990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 4 other ancestors3 generations back: 5 other ancestors 1 generation forward: 10 descendants2 generations forward: 40 descendants3 generations forward: 33 descendants4 generations forward: 22 descendants5 generations forward: 12 descendants6 generations forward: 9 descendants7 generations forward: 3 descendants8 generations forward: 3 descendants9 generations forward: 1 descendant K123850 · Ifuse Implant System · SI-BONE, Inc. · 2013K122074 · Ifuse Implant System · SI-BONE, Inc. · 2012K110838 · Ifuse Implant System · SI-BONE, Inc. · 2011K080398 · SI Joint Fusion System · SI-BONE, Inc. · 2008K051309 · Roi Fusion Rods & Plates · Reiley Orthopaedics, Inc. · 2005 · recalledK930834 · Acutract · Acu Med, Inc. · 1993−50+5
  1. Root · 6 generations backK930834 AcutractAcu Med, Inc. · 1993
  2. 5 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
  3. 4 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
  4. 3 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
  5. 2 generations backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
  6. 1 generation backK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
  7. This deviceK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
  8. Descendant · cites it directly · 88 of its ownK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
  9. Descendant · cites it directly · 86 of its ownK150875 iFuse Implant SystemSI-BONE, Inc. · 2015
  10. Descendant · cites it directly · 86 of its ownK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
  11. Descendant · cites it directly · 85 of its ownK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
  12. Descendant · cites it directly · 84 of its ownK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016

Showing 5 of 133 descendants. See all descendants

Descendants cleared per year

2014: 22015: 32016: 42017: 22018: 22019: 52020: 72021: 112022: 162023: 242024: 212025: 192026: 17
2014high 24 (2023) · low 2 (2014)2026

Most influential descendants

Showing 5 of 133 · See all
  • K141049Ifuse Implant SystemSI-BONE, Inc. · 2014 · cites it directly88descendants
  • K150875iFuse Implant SystemSI-BONE, Inc. · 2015 · cites it directly86descendants
  • K150714SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015 · cites it directly86descendants
  • K151718iFuse Implant SystemSI-BONE, Inc. · 2015 · cites it directly85descendants
  • K152681iFuse Implant System (R)SI-BONE, Inc. · 2016 · cites it directly84descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K930834AcutractAcu Med, Inc.1993—
−5K051309Roi Fusion Rods & PlatesReiley Orthopaedics, Inc.20052
−4K080398SI Joint Fusion SystemSI-BONE, Inc.2008—
−3K110838Ifuse Implant SystemSI-BONE, Inc.2011—
−2K122074Ifuse Implant SystemSI-BONE, Inc.2012—
−1K123850Ifuse Implant SystemSI-BONE, Inc.2013—
0 (this device)K131405Ifuse Implant SystemSI-BONE, Inc.2013—
+1K141049Ifuse Implant SystemSI-BONE, Inc.2014—
+1K150875iFuse Implant SystemSI-BONE, Inc.2015—
+1K150714SI-BONE iFuse Implant SystemSI-BONE, Inc.2015—
+1K151718iFuse Implant SystemSI-BONE, Inc.2015—
+1K152681iFuse Implant System (R)SI-BONE, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199510
199610
200010
200120
200220
200510
200910
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201420
201530
201640
201720
201820
201950
202070
2021110
2022160
2023240
2024210
2025190
2026170
FIG. 1 — Lineage of K131405, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K233508 iFuse Bedrock Granite® Implant Systemscore 30.7 · 31 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K080398SI Joint Fusion System
Summary page 1
…Rod Classification Name: 21 C.F.R. 888.3040 - Smooth or threaded metallic bone fastener; Product Code OUR Predicate Devices: iFuse Implant System®@ by SI-BONE, Inc. (K(080398, K(092375, KI 10838, K(122074, K 123850) Pioneer Cannulated Screw System by Pioneer Surgical Technology (1(102903) Intended Use…
SI-BONE, Inc.2008—
*K092375Modification to SI Joint Fusion System
Summary page 1
…iFuse Implant lengths range from 30-90mm with a diameter of 4-7 mm. The fusion rods are implanted using instrumentation similar to that previously described in K(080398, K092375, KI 10838, K1 22074 and K123850. Technological Characteristics The iFuse Implant System® consists of a series of metallic (titan…
SI-BONE, Inc.2009—
*K110838Ifuse Implant SystemSI-BONE, Inc.2011—
*K122074Ifuse Implant System
Summary page 1
…hs range from 30-90mm with a diameter of 4-7 mm. The fusion rods are implanted using instrumentation similar to that previously described in K(080398, K092375, KI 10838, K1 22074 and K123850. Technological Characteristics The iFuse Implant System® consists of a series of metallic (titanium), porous plasma…
SI-BONE, Inc.2012—
*K123850Ifuse Implant System
Summary page 1
…8.3040 - Smooth or threaded metallic bone fastener; Product Code OUR Predicate Devices: iFuse Implant System®@ by SI-BONE, Inc. (K(080398, K(092375, KI 10838, K(122074, K 123850) Pioneer Cannulated Screw System by Pioneer Surgical Technology (1(102903) Intended Use The iFuse System is intended for sacroil…
SI-BONE, Inc.2013—
*K102903Pioneer Cannulated Screw System
Summary page 1
…ate Devices: iFuse Implant System®@ by SI-BONE, Inc. (K(080398, K(092375, KI 10838, K(122074, K 123850) Pioneer Cannulated Screw System by Pioneer Surgical Technology (1(102903) Intended Use The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and…
Pioneer Surgical Technology, Inc.2010—

Also cleared against K080398: 10 other devices →

What descends from it? (133)

See all 133

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

NumberDeviceApplicantDecidedDescendants
K141049Ifuse Implant SystemSI-BONE, Inc.201488
K150875iFuse Implant SystemSI-BONE, Inc.201586
K150714SI-BONE iFuse Implant SystemSI-BONE, Inc.201586
K151718iFuse Implant SystemSI-BONE, Inc.201585
K152681iFuse Implant System (R)SI-BONE, Inc.201684
K160652iFUSE Implant SystemSI-BONE, Inc.201683
K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679
K172268iFuse Implant System- iFuse NavigationSI-BONE, Inc.201746
K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830
K140079Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc.201412

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 20 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
  • 4 of the 17 ancestors have a recall of any class.
  • Of its descendants, K141049 (SI-BONE, Inc., 2014) has gone furthest, with 88 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. 2013, this device’s year, is highlighted.

FDA decisions per year · OUR

14in 2025

2008: 12009: 12010: 12011: 32012: 22013: 42014: 32015: 82016: 62017: 42018: 72019: 72020: 72021: 92022: 142023: 202024: 152025: 142026 (partial year): 6
2007high 20 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OUR

97in 2025

2011: 27 days median2013: 103 days median2014: 91 days median2015: 111 days median2016: 168 days median2017: 120 days median2018: 82 days median2019: 89 days median2020: 88 days median2021: 85 days median2022: 149 days median2023: 55 days median2024: 74 days median2025: 97 days median2026 (partial year): 98 days median
2007high 168 (2016) · low 27 (2011)2026

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

Recalls per year · OUR

1in 2025

2025: 12026 (partial year): 1
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

2011: 62012: 812013: 962014: 1462015: 1192016: 1222017: 1572018: 1372019: 1752020: 1482021: 1542022: 232023: 72024: 152025: 10
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—00
20091—00
20101—00
201132706
20122—081
20134103096
20143910146
201581110119
201661680122
201741200157
20187820137
20197890175
20207880148
20219850154
202214149023
2023205507
20241574015
20251497110
20266981—

What is it indicated for?

The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Indications for use as stated in the FDA summary.

Also cleared against K080398

10 other devices cite the same predicate.

  • K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine · 2019
  • K160652iFUSE Implant SystemSI-BONE, Inc. · 2016
  • K151718iFuse Implant SystemSI-BONE, Inc. · 2015
  • K150875iFuse Implant SystemSI-BONE, Inc. · 2015
  • K150714SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
  • K141049Ifuse Implant SystemSI-BONE, Inc. · 2014

More from SI-BONE, Inc.

33 FDA decisions under this applicant name. See the company

  • K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc. · 2026
  • K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc. · 2026
  • K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc. · 2025
  • K251780iGPS Navigation InstrumentsSI-BONE, Inc. · 2025
  • K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc. · 2024

Recent decisions in OUR

The OUR category page

  • K262522Odys-SI ScrewMedyssey Co, Ltd. · 2026
  • K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLC · 2026
  • K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical · 2026
  • K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc. · 2026
  • K253611Falco Fusion SystemMcnicoll Surgical, Inc. · 2026

https://510kreport.com/device/K131405 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131405: 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/K131405

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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