510(k) Report

510(k) · Cleared

Cleared

SI-Fix Sacroiliac Joint Fusion System

K110472510(k) TraditionalCleared May 29, 2012466-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

Medtronic Sofamor Danek · OUR Sacroiliac Joint Fixation

Cleared on May 29, 2012 as substantially equivalent to K110838 (SI-BONE, Inc., 2011) and 8 other predicates after a 466-day review. Its family tree reaches back 6 generations to 1990. 92 later devices descend from it.

Decided
May 29, 2012
Review
466 days
Class
Class II
Product code
OUR
Recalls
None
Predicates
9

Its longest line of descent runs back 6 generations to K903810 (1990). 20 ancestors in all. 92 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2010: 1 other ancestor2009: 1 other ancestor2008: 1 other ancestor2002: 2 other ancestors1991: 1 other ancestor2005: 1 other ancestor2001: 2 other ancestors2000: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor1993: 1 other ancestor2018: 2 descendants cleared2016: 3 descendants cleared2024: 15 descendants cleared2021: 8 descendants cleared2014: 1 descendant cleared2019: 3 descendants cleared2023: 22 descendants cleared2026: 12 descendants cleared2025: 13 descendants cleared2020: 1 descendant cleared2022: 12 descendants clearedK903810 · Ace Cannulated Self Tapping Cancellous Bone Screw · Ace Medical Co. · 1990K051296 · Sijf Cannulated Screw System · Depuy Spine, Inc. · 2005×3: 3 generations cleared close together, K102907 (2010), K110512 (2011), K111801 (2011) K112028 · SI-Lok Sacroiliac Joint Fixation System · Globus Medical, Inc. · 20111990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 5 other ancestors3 generations back: 3 other ancestors 1 generation forward: 7 descendants2 generations forward: 42 descendants3 generations forward: 26 descendants4 generations forward: 14 descendants5 generations forward: 3 descendants K112028 · SI-Lok Sacroiliac Joint Fixation System · Globus Medical, Inc. · 2011K111801 · Simmetry (TM) Sacroiliac Joint Fusion System · Zyga Technology, Inc. · 2011K110512 · Simmetry Sacroiliac Joint Fusion System · Zyga Technology, Inc. · 2011K102907 · Simmetry Sacroiliac Joint Fusion System · Zyga Technology, Inc. · 2010K051296 · Sijf Cannulated Screw System · Depuy Spine, Inc. · 2005K903810 · Ace Cannulated Self Tapping Cancellous Bone Screw · Ace Medical Co. · 1990−50+5
  1. Root · 6 generations backK903810 Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co. · 1990
  2. 5 generations backK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
  3. 4 generations backK102907 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010
  4. 3 generations backK110512 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
  5. 2 generations backK111801 Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
  6. 1 generation backK112028 SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc. · 2011
  7. This deviceK110472 SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek · 2012
  8. Descendant · cites it directly · 79 of its ownK161210 RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2016
  9. Descendant · cites it directly · 30 of its ownK180818 Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc. · 2018
  10. Descendant · 2 generations on · 22 of its ownK191748 Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine · 2019
  11. Descendant · 3 generations on · 17 of its ownK203247 iFuse-TORQ™ Implant SystemSI-BONE, Inc. · 2021 · Recalled
  12. Descendant · 4 generations on · 15 of its ownK213667 iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022

Showing 5 of 92 descendants. See all descendants

Descendants cleared per year

2014: 12016: 32018: 22019: 32020: 12021: 82022: 122023: 222024: 152025: 132026: 12
2014high 22 (2023) · low 0 (2015)2026

Most influential descendants

Showing 5 of 92 · See all
  • K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek · 2016 · cites it directly79descendants
  • K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc. · 2018 · cites it directly30descendants
  • K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine · 2019 · 2 generations on22descendants
  • K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc. · 2021 · 3 generations on17descendants
  • K213667iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022 · 4 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K903810Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co.1990—
−5K051296Sijf Cannulated Screw SystemDepuy Spine, Inc.2005—
−4K102907Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.2010—
−3K110512Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.2011—
−2K111801Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc.2011—
−1K112028SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc.2011—
0 (this device)K110472SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek2012—
+1K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the…Medtronic Sofamor Danek2016—
+1K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.2018—
+2K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine2019—
+3K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.20211
+4K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199310
199510
199610
200010
200120
200220
200510
200810
200910
201010
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201630
201820
201930
202010
202180
2022120
2023220
2024150
2025130
2026120
FIG. 1 — Lineage of K110472, 1990–2026Source: 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
Cleared while this submission was under review
Summary page 2
…was provided which demonstrated that the subject device is substantially equivalent to the iFuse Implant System manufactured by SI-Bone (K110838, SE 04/21/11, K092375, SE 09/04/09 and K080398, SE 11/26/08); as well as the Pioneer Cannulated S…
SI-BONE, Inc.2011—
*K092375Modification to SI Joint Fusion System
Summary page 2
…monstrated that the subject device is substantially equivalent to the iFuse Implant System manufactured by SI-Bone (K110838, SE 04/21/11, K092375, SE 09/04/09 and K080398, SE 11/26/08); as well as the Pioneer Cannulated Screw System (K102903,…
SI-BONE, Inc.2009—
*K080398SI Joint Fusion System
Summary page 2
…device is substantially equivalent to the iFuse Implant System manufactured by SI-Bone (K110838, SE 04/21/11, K092375, SE 09/04/09 and K080398, SE 11/26/08); as well as the Pioneer Cannulated Screw System (K102903, SE 10/20/10); Globus Medical…
SI-BONE, Inc.2008—
*K102903Pioneer Cannulated Screw System
Summary page 2
…actured by SI-Bone (K110838, SE 04/21/11, K092375, SE 09/04/09 and K080398, SE 11/26/08); as well as the Pioneer Cannulated Screw System (K102903, SE 10/20/10); Globus Medical SI-LOK Sacroiliac Joint Fixation System (KI 12028; SE 12/09/11); Zy…
Pioneer Surgical Technology, Inc.2010—
*K112028SI-Lok Sacroiliac Joint Fixation System
Cleared while this submission was under review
Globus Medical, Inc.2011—
*K111801Simmetry (TM) Sacroiliac Joint Fusion System
Cleared while this submission was under review
Zyga Technology, Inc.2011—
*K051296Sijf Cannulated Screw System
Summary page 2
…28; SE 12/09/11); Zyga's SimmetryTM Sacroiliac Joint Fusion System (KI 11801, 7/21/1l), the DePuy SIJF Cannulated Screw System (K051296, SE 08/26/05), the Synthes 6.5 Cannulated Screw (K021932, SE 09/06/02) and the Aiphatec Cannulate…
Depuy Spine, Inc.2005—
*K021932Synthes 6.5 MM Cannulated Screw
Summary page 2
…nt Fusion System (KI 11801, 7/21/1l), the DePuy SIJF Cannulated Screw System (K051296, SE 08/26/05), the Synthes 6.5 Cannulated Screw (K021932, SE 09/06/02) and the Aiphatec Cannulated Bone Screws (K914004, SE 12/05/91). DEPARTMENT OF HEA…
Synthes (Usa)20027
*K914004Alphatec Cannulated Bone Screws
Summary page 2
…ted Screw System (K051296, SE 08/26/05), the Synthes 6.5 Cannulated Screw (K021932, SE 09/06/02) and the Aiphatec Cannulated Bone Screws (K914004, SE 12/05/91). DEPARTMENT OF HEALTH &HUMAN SERVICES,…
Alphatec Mfg., Inc.1991—

Also cleared against K110838: 10 other devices →

What descends from it? (92)

See all 92

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

NumberDeviceApplicantDecidedDescendants
K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679
K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830
K140079Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc.201412
K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218
K181881Outlet Sacroiliac Joint Fusion SystemSij Surgical20184
K161755Integrity-SI TM Fusion SystemCoorstek Medical20162
K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240

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 5 companies; a new generation was cleared every 6 months on median.
  • 4 of the 20 ancestors have a recall of any class.
  • Of its descendants, K161210 (Medtronic Sofamor Danek, 2016) has gone furthest, with 79 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. 2012, 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 MSB Sacroiliac Joint Fusion Device is intended for sacroiliac joint fuision for conditions including sacroiliac joint disruptions and degenerative sacroillitis.

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
  • K152681iFuse Implant System (R)SI-BONE, Inc. · 2016
  • K151718iFuse Implant SystemSI-BONE, Inc. · 2015
  • K150875iFuse Implant SystemSI-BONE, Inc. · 2015
  • K150714SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015

More from Medtronic Sofamor Danek

154 FDA decisions under this applicant name. See the company

  • K212428Centerpiece Plate Fixation SystemMedtronic Sofamor Danek · 2021
  • K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
  • K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek · 2017
  • K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System TitaniumMedtronic Sofamor Danek · 2017
  • K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek · 2017

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/K110472 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110472: SI-Fix Sacroiliac Joint Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110472

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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