510(k) Report

510(k) · Cleared

Cleared

SI-Lok Sacroiliac Joint Fixation System

K112028510(k) TraditionalCleared Dec 9, 2011147-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

Globus Medical, Inc. · HWC Screw, Fixation, Bone

Cleared on Dec 9, 2011 as substantially equivalent to K021932 (Synthes (Usa), 2002) and 4 other predicates after a 147-day review. Its family tree reaches back 5 generations to 1990. 1 of the 249 devices in its family, counting itself, has a Class I recall. 238 later devices descend from it.

Decided
Dec 9, 2011
Review
147 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K903810 (1990). 10 ancestors in all. 238 later devices descend from it, 16 citing it directly. 1 of the 249 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2002: 2 other ancestors1996: 1 other ancestor2000: 1 other ancestor2009: 1 other ancestor2019: 10 descendants cleared2023: 40 descendants cleared2015: 4 descendants cleared2014: 2 descendants cleared2012: 2 descendants cleared2017: 4 descendants cleared2020: 10 descendants cleared2016: 6 descendants cleared2018: 7 descendants cleared2024: 37 descendants cleared2021: 18 descendants cleared, 1 with a Class I recall12022: 24 descendants cleared2026: 38 descendants cleared2025: 36 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) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 1 other ancestor 1 generation forward: 16 descendants2 generations forward: 64 descendants, 1 with a Class I recall13 generations forward: 65 descendants4 generations forward: 39 descendants5 generations forward: 26 descendants6 generations forward: 11 descendants7 generations forward: 7 descendants8 generations forward: 6 descendants9 generations forward: 4 descendants K111801 · 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 · 5 generations backK903810 Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co. · 1990
  2. 4 generations backK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
  3. 3 generations backK102907 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010
  4. 2 generations backK110512 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
  5. 1 generation backK111801 Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
  6. This deviceK112028 SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc. · 2011
  7. Descendant · cites it directly · 92 of its ownK110472 SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek · 2012
  8. Descendant · cites it directly · 84 of its ownK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
  9. Descendant · 2 generations on · 83 of its ownK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
  10. Descendant · 3 generations on · 82 of its ownK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
  11. Descendant · 2 generations on · 79 of its ownK161210 RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2016

Showing 5 of 238 descendants. See all descendants

Descendants cleared per year

2012: 22014: 22015: 42016: 62017: 42018: 72019: 102020: 102021: 182022: 242023: 402024: 372025: 362026: 38
2012high 40 (2023) · low 0 (2013)2026

Class I recalls in this family

  • K211616 ExcelsiusHub2 generations on · 2021

Most influential descendants

Showing 5 of 238 · See all
  • K110472SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek · 2012 · cites it directly92descendants
  • K152681iFuse Implant System (R)SI-BONE, Inc. · 2016 · cites it directly84descendants
  • K160652iFUSE Implant SystemSI-BONE, Inc. · 2016 · 2 generations on83descendants
  • K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017 · 3 generations on82descendants
  • K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek · 2016 · 2 generations on79descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K903810Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co.1990—
−4K051296Sijf Cannulated Screw SystemDepuy Spine, Inc.2005—
−3K102907Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.2010—
−2K110512Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.2011—
−1K111801Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc.2011—
0 (this device)K112028SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc.2011—
+1K110472SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek2012—
+1K152681iFuse Implant System (R)SI-BONE, Inc.2016—
+2K160652iFUSE Implant SystemSI-BONE, Inc.2016—
+3K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc.2017—
+2K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the…Medtronic Sofamor Danek2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200010
200220
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201420
201540
201660
201740
201870
2019100
2020100
2021181
2022240
2023400
2024370
2025360
2026380
FIG. 1 — Lineage of K112028, 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.

1 device in this family has a Class I recall. 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 14 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? (5)

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
*K021932Synthes 6.5 MM Cannulated Screw
Summary page 1
…d metallic bone fixation fastener Product Codes: HWC, OUR Regulatory Class: 11,Panel Code: 87 Predicate(s): Synthes Cannulated Screw (K021 932) SE date: September 6, 2002, re-evaluated April 7, 2011 Synthes Cannulated Screw (K96201 1)…
Synthes (Usa)20027
*K962011Synthes 7.0/7.3 MM Cannulated Screws
Summary page 1
…redicate(s): Synthes Cannulated Screw (K021 932) SE date: September 6, 2002, re-evaluated April 7, 2011 Synthes Cannulated Screw (K96201 1) SE date: August 5, 1996 DePuy Spine SIJF Cannulated Screw System (KO051296)…
Synthes (Usa)1996—
*K051296Sijf Cannulated Screw System
Summary page 1
…ril 7, 2011 Synthes Cannulated Screw (K96201 1) SE date: August 5, 1996 DePuy Spine SIJF Cannulated Screw System (KO051296) SE date: August 26, 2005, re-evaluated April 7, 2011 Zyga Technology Slmmetry Joint Fusion…
Depuy Spine, Inc.2005—
*K111801Simmetry (TM) Sacroiliac Joint Fusion System
Cleared while this submission was under review
Summary page 1
…annulated Screw System (KO051296) SE date: August 26, 2005, re-evaluated April 7, 2011 Zyga Technology Slmmetry Joint Fusion System (K1 11801, K1 10512) SE date: July 21, 2011, March 23, 2011 Purpose: The purpose of this submission is to request clear…
Zyga Technology, Inc.2011—
*K110512Simmetry Sacroiliac Joint Fusion System
Summary page 1
…Screw System (KO051296) SE date: August 26, 2005, re-evaluated April 7, 2011 Zyga Technology Slmmetry Joint Fusion System (K1 11801, K1 10512) SE date: July 21, 2011, March 23, 2011 Purpose: The purpose of this submission is to request clearance for t…
Zyga Technology, Inc.2011—

Also cleared against K021932: 61 other devices →

What descends from it? (238)

See all 238

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

NumberDeviceApplicantDecidedDescendants
K110472SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek201292
K152681iFuse Implant System (R)SI-BONE, Inc.201684
K171651Excelsius GPSGlobus Medical, Inc.201769
K141549SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201563
K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.201735
K121148Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM…Medical Design, LLC201235
K141246Life Spine Sacroiliac Joint Fixation SystemLife Spine, Inc.201529
K140079Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc.201412
K151462SI-Technology® SI-Desis® ScrewsSi-Technology, LLC20155
K181881Outlet Sacroiliac Joint Fusion SystemSij Surgical20184

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 5 months on median.
  • 2 of the 10 ancestors have a recall of any class.
  • Of its descendants, K110472 (Medtronic Sofamor Danek, 2012) has gone furthest, with 92 descendants of its own.
  • 61 other devices also cite its predicate K021932.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The SI-LOK TM Sacroiliac Joint Fixation 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 K021932

61 other devices cite the same predicate.

  • K252322SIros-X SystemGenesys Spine · 2025
  • K250647SImmetry+ SystemSivantage · 2025
  • K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC · 2025
  • K243838NEXXT MATRIXX® SI SystemNexxt Spine · 2025
  • K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC · 2024
  • K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset…Lesspine Innovations · 2023

More from Globus Medical, Inc.

184 FDA decisions under this applicant name. See the company

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc. · 2026
  • K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System…Globus Medical, Inc. · 2026
  • K253401SCRIPT™ Implant SystemGlobus Medical, Inc. · 2026

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K112028 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112028: SI-Lok Sacroiliac Joint Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112028

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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