510(k) Report

510(k) · Cleared

Cleared

iFUSE Implant System

K160652510(k) TraditionalCleared Jun 3, 201687-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 Jun 3, 2016 as substantially equivalent to K080398 (SI-BONE, Inc., 2008) and 10 other predicates after an 87-day review. Its family tree reaches back 11 generations to 1993. 83 later devices descend from it.

Decided
Jun 3, 2016
Review
87 days
Class
Class II
Product code
OUR
Recalls
None
Predicates
11

Its longest line of descent runs back 11 generations to K930834 (1993). 27 ancestors in all, the oldest K903810 (1990). 83 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 1 other ancestor2009: 1 other ancestor2011: 3 other ancestors2010: 2 other ancestors2005: 1 other ancestor2002: 2 other ancestors2001: 2 other ancestors2000: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor1990: 1 other ancestor2017: 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. · 2015×2: 2 generations cleared close together, K151718 (2015), K152681 (2016) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 4 other ancestors3 generations back: 9 other ancestors4 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 8 descendants4 generations forward: 15 descendants5 generations forward: 23 descendants6 generations forward: 22 descendants7 generations forward: 8 descendants8 generations forward: 2 descendants K152681 · iFuse Implant System (R) · SI-BONE, Inc. · 2016K151718 · 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 · 11 generations backK930834 AcutractAcu Med, Inc. · 1993
  2. 7 generations between
  3. 3 generations backK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
  4. 2 generations backK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
  5. 1 generation backK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
  6. This deviceK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
  7. Descendant · cites it directly · 82 of its ownK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
  8. Descendant · 2 generations on · 71 of its ownK182983 iFuse Implant System®SI-BONE, Inc. · 2018
  9. Descendant · 3 generations on · 57 of its ownK190230 iFuse Implant System®SI-BONE, Inc. · 2019
  10. Descendant · 4 generations on · 54 of its ownK193524 SI-BONE iFuse Implant System®SI-BONE, Inc. · 2020
  11. Descendant · 2 generations on · 46 of its ownK172268 iFuse Implant System- iFuse NavigationSI-BONE, Inc. · 2017
Show all 11 generations
  1. Root · 11 generations backK930834 AcutractAcu Med, Inc. · 1993
  2. 10 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
  3. 9 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
  4. 8 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
  5. 7 generations backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
  6. 6 generations backK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
  7. 5 generations backK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
  8. 4 generations backK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
  9. 3 generations backK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
  10. 2 generations backK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
  11. 1 generation backK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
  12. This deviceK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016

Showing 5 of 83 descendants. See all descendants

Descendants cleared per year

2017: 22018: 12019: 32020: 62021: 72022: 122023: 142024: 112025: 142026: 13
2017high 14 (2023) · low 1 (2018)2026

Most influential descendants

Showing 5 of 83 · See all
  • K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017 · cites it directly82descendants
  • K182983iFuse Implant System®SI-BONE, Inc. · 2018 · 2 generations on71descendants
  • K190230iFuse Implant System®SI-BONE, Inc. · 2019 · 3 generations on57descendants
  • K193524SI-BONE iFuse Implant System®SI-BONE, Inc. · 2020 · 4 generations on54descendants
  • K172268iFuse Implant System- iFuse NavigationSI-BONE, Inc. · 2017 · 2 generations on46descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K930834AcutractAcu Med, Inc.1993—
−10K051309Roi Fusion Rods & PlatesReiley Orthopaedics, Inc.20052
−9K080398SI Joint Fusion SystemSI-BONE, Inc.2008—
−8K110838Ifuse Implant SystemSI-BONE, Inc.2011—
−7K122074Ifuse Implant SystemSI-BONE, Inc.2012—
−6K123850Ifuse Implant SystemSI-BONE, Inc.2013—
−5K131405Ifuse Implant SystemSI-BONE, Inc.2013—
−4K141049Ifuse Implant SystemSI-BONE, Inc.2014—
−3K150714SI-BONE iFuse Implant SystemSI-BONE, Inc.2015—
−2K151718iFuse Implant SystemSI-BONE, Inc.2015—
−1K152681iFuse Implant System (R)SI-BONE, Inc.2016—
0 (this device)K160652iFUSE Implant SystemSI-BONE, Inc.2016—
+1K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc.2017—
+2K182983iFuse Implant System®SI-BONE, Inc.2018—
+3K190230iFuse Implant System®SI-BONE, Inc.2019—
+4K193524SI-BONE iFuse Implant System®SI-BONE, Inc.2020—
+2K172268iFuse Implant System- iFuse NavigationSI-BONE, Inc.2017—

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
201720
201810
201930
202060
202170
2022120
2023140
2024110
2025140
2026130
FIG. 1 — Lineage of K160652, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (11)

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 4
…dic 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. (K080398, K092375, K110838, K122074, K123850, K131405, K141049 and K150714, K150875, K151718, K152681) Indications for Use The iFuse Impl…
SI-BONE, Inc.2008—
*K092375Modification to SI Joint Fusion System
Summary page 4
…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. (K080398, K092375, K110838, K122074, K123850, K131405, K141049 and K150714, K150875, K151718, K152681) Indications for Use The iFuse Implant Syste…
SI-BONE, Inc.2009—
*K110838Ifuse Implant System
Summary page 4
…ation 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. (K080398, K092375, K110838, K122074, K123850, K131405, K141049 and K150714, K150875, K151718, K152681) Indications for Use The iFuse Implant System is inte…
SI-BONE, Inc.2011—
*K122074Ifuse Implant System
Summary page 4
…e: 21 C.F.R. 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, K141049 and K150714, K150875, K151718, K152681) Indications for Use The iFuse Implant System is intended for…
SI-BONE, Inc.2012—
*K123850Ifuse Implant System
Summary page 4
….R. 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, K141049 and K150714, K150875, K151718, K152681) Indications for Use The iFuse Implant System is intended for sacroilia…
SI-BONE, Inc.2013—
*K131405Ifuse Implant System
Summary page 4
…040 – Smooth or threaded metallic bone fastener; Product Code OUR Predicate Devices: iFuse Implant System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405, K141049 and K150714, K150875, K151718, K152681) Indications for Use The iFuse Implant System is intended for sacroiliac fusion…
SI-BONE, Inc.2013—
*K141049Ifuse Implant System
Summary page 4
…oth or threaded metallic bone fastener; Product Code OUR Predicate Devices: iFuse Implant System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405, K141049 and K150714, K150875, K151718, K152681) Indications for Use The iFuse Implant System is intended for sacroiliac fusion for condi…
SI-BONE, Inc.2014—
*K150714SI-BONE iFuse Implant System
Summary page 4
…ded metallic bone fastener; Product Code OUR Predicate Devices: iFuse Implant System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405, K141049 and K150714, K150875, K151718, K152681) Indications for Use The iFuse Implant System is intended for sacroiliac fusion for conditions includ…
SI-BONE, Inc.2015—
*K150875iFuse Implant System
Summary page 4
…lic bone fastener; Product Code OUR Predicate Devices: iFuse Implant System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405, K141049 and K150714, K150875, K151718, K152681) Indications for Use The iFuse Implant System is intended for sacroiliac fusion for conditions including sacro…
SI-BONE, Inc.2015—
*K151718iFuse Implant System
Summary page 4
…fastener; Product Code OUR Predicate Devices: iFuse Implant System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405, K141049 and K150714, K150875, K151718, K152681) Indications for Use The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joi…
SI-BONE, Inc.2015—
*K152681iFuse Implant System (R)
Summary page 4
…Product Code OUR Predicate Devices: iFuse Implant System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405, K141049 and K150714, K150875, K151718, K152681) Indications for Use The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfun…
SI-BONE, Inc.2016—

Also cleared against K080398: 10 other devices →

What descends from it? (83)

See all 83

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

NumberDeviceApplicantDecidedDescendants
K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc.201782

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 27 ancestors have a recall of any class.
  • Of its descendants, K162733 (SI-BONE, Inc., 2017) has gone furthest, with 82 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. 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.

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
  • 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
  • K131405Ifuse Implant SystemSI-BONE, Inc. · 2013

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/K160652 · printed Nov 6, 2026

Cite this page

510(k) Report. “K160652: 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/K160652

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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