510(k) Report

510(k) · Cleared

Cleared

iFuse Implant System (R)

K152681510(k) TraditionalCleared Mar 1, 2016165-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 Mar 1, 2016 as substantially equivalent to K110838 (SI-BONE, Inc., 2011) and 8 other predicates after a 165-day review. Its family tree reaches back 10 generations to 1993. 84 later devices descend from it.

Decided
Mar 1, 2016
Review
165 days
Class
Class II
Product code
OUR
Recalls
None
Predicates
9

Its longest line of descent runs back 10 generations to K930834 (1993). 26 ancestors in all, the oldest K903810 (1990). 84 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 1 other ancestor2011: 3 other ancestors2010: 2 other ancestors2009: 1 other ancestor2005: 1 other ancestor2002: 2 other ancestors1996: 1 other ancestor2001: 2 other ancestors2000: 1 other ancestor1990: 1 other ancestor1995: 1 other ancestor2016: 1 descendant cleared2017: 2 descendants cleared2019: 3 descendants cleared2018: 1 descendant cleared2026: 13 descendants cleared2022: 12 descendants cleared2020: 6 descendants cleared2024: 11 descendants cleared2021: 7 descendants cleared2023: 14 descendants cleared2025: 14 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. · 2013K131405 · Ifuse Implant System · SI-BONE, Inc. · 2013K141049 · Ifuse Implant System · SI-BONE, Inc. · 2014K150714 · SI-BONE iFuse Implant System · SI-BONE, Inc. · 2015K151718 · iFuse Implant System · SI-BONE, Inc. · 20151990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 7 other ancestors3 generations back: 5 other ancestors4 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 4 descendants4 generations forward: 8 descendants5 generations forward: 15 descendants6 generations forward: 23 descendants7 generations forward: 22 descendants8 generations forward: 8 descendants9 generations forward: 2 descendants K151718 · iFuse Implant System · SI-BONE, Inc. · 2015K150714 · SI-BONE iFuse Implant System · SI-BONE, Inc. · 2015K141049 · Ifuse Implant System · SI-BONE, Inc. · 2014K131405 · Ifuse Implant System · SI-BONE, Inc. · 2013K123850 · 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. · 1993−10−50+5
  1. Root · 10 generations backK930834 AcutractAcu Med, Inc. · 1993
  2. 6 generations between
  3. 3 generations backK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
  4. 2 generations backK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
  5. 1 generation backK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
  6. This deviceK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
  7. Descendant · cites it directly · 83 of its ownK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
  8. Descendant · 2 generations on · 82 of its ownK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
  9. Descendant · 3 generations on · 71 of its ownK182983 iFuse Implant System®SI-BONE, Inc. · 2018
  10. Descendant · 4 generations on · 57 of its ownK190230 iFuse Implant System®SI-BONE, Inc. · 2019
  11. Descendant · 5 generations on · 54 of its ownK193524 SI-BONE iFuse Implant System®SI-BONE, Inc. · 2020
Show all 10 generations
  1. Root · 10 generations backK930834 AcutractAcu Med, Inc. · 1993
  2. 9 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
  3. 8 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
  4. 7 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
  5. 6 generations backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
  6. 5 generations backK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
  7. 4 generations backK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
  8. 3 generations backK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
  9. 2 generations backK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
  10. 1 generation backK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
  11. This deviceK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016

Showing 5 of 84 descendants. See all descendants

Descendants cleared per year

2016: 12017: 22018: 12019: 32020: 62021: 72022: 122023: 142024: 112025: 142026: 13
2016high 14 (2023) · low 1 (2016)2026

Most influential descendants

Showing 5 of 84 · See all
  • 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
  • K190230iFuse Implant System®SI-BONE, Inc. · 2019 · 4 generations on57descendants
  • K193524SI-BONE iFuse Implant System®SI-BONE, Inc. · 2020 · 5 generations on54descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K930834AcutractAcu Med, Inc.1993—
−9K051309Roi Fusion Rods & PlatesReiley Orthopaedics, Inc.20052
−8K080398SI Joint Fusion SystemSI-BONE, Inc.2008—
−7K110838Ifuse Implant SystemSI-BONE, Inc.2011—
−6K122074Ifuse Implant SystemSI-BONE, Inc.2012—
−5K123850Ifuse Implant SystemSI-BONE, Inc.2013—
−4K131405Ifuse Implant SystemSI-BONE, Inc.2013—
−3K141049Ifuse Implant SystemSI-BONE, Inc.2014—
−2K150714SI-BONE iFuse Implant SystemSI-BONE, Inc.2015—
−1K151718iFuse Implant SystemSI-BONE, Inc.2015—
0 (this device)K152681iFuse Implant System (R)SI-BONE, Inc.2016—
+1K160652iFUSE Implant SystemSI-BONE, Inc.2016—
+2K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc.2017—
+3K182983iFuse Implant System®SI-BONE, Inc.2018—
+4K190230iFuse Implant System®SI-BONE, Inc.2019—
+5K193524SI-BONE iFuse Implant System®SI-BONE, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199510
199610
200010
200120
200220
200510
200910
201020
201130
201510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201720
201810
201930
202060
202170
2022120
2023140
2024110
2025140
2026130
FIG. 1 — Lineage of K152681, 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? (9)

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
*K110838Ifuse Implant System
Summary page 4
…ber: 21 CFR 888.3040 – Smooth or threaded metallic bone fastener Product Code: OUR; Sacroiliac Joint Fixation Predicate Devices: iFuse Implant System by SI-BONE, Inc. (K110838, K122074, K123850, K131405, K141049, K150714, K150875, K151718) Globus SI-LOK Sacroiliac Joint Fixation System (K112028) Intende…
SI-BONE, Inc.2011—
*K122074Ifuse Implant System
Summary page 4
…FR 888.3040 – Smooth or threaded metallic bone fastener Product Code: OUR; Sacroiliac Joint Fixation Predicate Devices: iFuse Implant System by SI-BONE, Inc. (K110838, K122074, K123850, K131405, K141049, K150714, K150875, K151718) Globus SI-LOK Sacroiliac Joint Fixation System (K112028) Intended Use The…
SI-BONE, Inc.2012—
*K123850Ifuse Implant System
Summary page 4
…40 – Smooth or threaded metallic bone fastener Product Code: OUR; Sacroiliac Joint Fixation Predicate Devices: iFuse Implant System by SI-BONE, Inc. (K110838, K122074, K123850, K131405, K141049, K150714, K150875, K151718) Globus SI-LOK Sacroiliac Joint Fixation System (K112028) Intended Use The iFuse Im…
SI-BONE, Inc.2013—
*K131405Ifuse Implant System
Summary page 4
…th or threaded metallic bone fastener Product Code: OUR; Sacroiliac Joint Fixation Predicate Devices: iFuse Implant System by SI-BONE, Inc. (K110838, K122074, K123850, K131405, K141049, K150714, K150875, K151718) Globus SI-LOK Sacroiliac Joint Fixation System (K112028) Intended Use The iFuse Implant Sys…
SI-BONE, Inc.2013—
*K141049Ifuse Implant System
Summary page 4
…eaded metallic bone fastener Product Code: OUR; Sacroiliac Joint Fixation Predicate Devices: iFuse Implant System by SI-BONE, Inc. (K110838, K122074, K123850, K131405, K141049, K150714, K150875, K151718) Globus SI-LOK Sacroiliac Joint Fixation System (K112028) Intended Use The iFuse Implant System is in…
SI-BONE, Inc.2014—
*K150714SI-BONE iFuse Implant System
Summary page 4
…allic bone fastener Product Code: OUR; Sacroiliac Joint Fixation Predicate Devices: iFuse Implant System by SI-BONE, Inc. (K110838, K122074, K123850, K131405, K141049, K150714, K150875, K151718) Globus SI-LOK Sacroiliac Joint Fixation System (K112028) Intended Use The iFuse Implant System is intended fo…
SI-BONE, Inc.2015—
*K150875iFuse Implant System
Summary page 4
…e fastener Product Code: OUR; Sacroiliac Joint Fixation Predicate Devices: iFuse Implant System by SI-BONE, Inc. (K110838, K122074, K123850, K131405, K141049, K150714, K150875, K151718) Globus SI-LOK Sacroiliac Joint Fixation System (K112028) Intended Use The iFuse Implant System is intended for sacroil…
SI-BONE, Inc.2015—
*K151718iFuse Implant System
Cleared while this submission was under review
Summary page 4
…r Product Code: OUR; Sacroiliac Joint Fixation Predicate Devices: iFuse Implant System by SI-BONE, Inc. (K110838, K122074, K123850, K131405, K141049, K150714, K150875, K151718) Globus SI-LOK Sacroiliac Joint Fixation System (K112028) Intended Use The iFuse Implant System is intended for sacroiliac fusio…
SI-BONE, Inc.2015—
*K112028SI-Lok Sacroiliac Joint Fixation System
Summary page 4
…e Devices: iFuse Implant System by SI-BONE, Inc. (K110838, K122074, K123850, K131405, K141049, K150714, K150875, K151718) Globus SI-LOK Sacroiliac Joint Fixation System (K112028) Intended Use The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction t…
Globus Medical, Inc.2011—

Also cleared against K110838: 10 other devices →

What descends from it? (84)

See all 84

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K160652iFUSE Implant SystemSI-BONE, Inc.201683

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 23 years and passes through 3 companies; a new generation was cleared every 9 months on median.
  • 4 of the 26 ancestors have a recall of any class.
  • Of its descendants, K160652 (SI-BONE, Inc., 2016) has gone furthest, with 83 descendants of its own.
  • 10 other devices also cite its predicate K110838.

How does its category compare?

All OUR devices

OUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 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. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life at 12 months post-implantation.

Indications for use as stated in the FDA summary.

Also cleared against K110838

10 other devices cite the same predicate.

  • K193524SI-BONE iFuse Implant System®SI-BONE, Inc. · 2020
  • 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/K152681 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152681: iFuse Implant System (R).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152681

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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