510(k) Report

510(k) · Cleared

Cleared

SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments

K183119510(k) TraditionalCleared Feb 6, 201989-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. · OUR Sacroiliac Joint Fixation

Cleared on Feb 6, 2019 as substantially equivalent to K112028 (Globus Medical, Inc., 2011) and 6 other predicates after an 89-day review. Its family tree reaches back 19 generations to 2004. 1 of the 475 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided
Feb 6, 2019
Review
89 days
Class
Class II
Product code
OUR
Recalls
None
Predicates
7

Its longest line of descent runs back 19 generations to K040583 (2004). 472 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 2 citing it directly. 1 of the 475 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2018: 1 other ancestor2016: 2 other ancestors2011: 16 other ancestors2002: 25 other ancestors1996: 17 other ancestors2017: 1 other ancestor2015: 7 other ancestors2014: 5 other ancestors2013: 9 other ancestors2012: 7 other ancestors2005: 36 other ancestors2010: 15 other ancestors, 1 with a Class I recall12009: 15 other ancestors2008: 27 other ancestors2006: 23 other ancestors2000: 26 other ancestors1999: 19 other ancestors1998: 17 other ancestors1991: 2 other ancestors1990: 2 other ancestors2007: 15 other ancestors2004: 42 other ancestors2003: 25 other ancestors2001: 37 other ancestors1997: 12 other ancestors1994: 7 other ancestors1993: 4 other ancestors1995: 16 other ancestors1988: 2 other ancestors1987: 3 other ancestors1979: 1 other ancestor1978: 1 other ancestor1992: 3 other ancestors1989: 5 other ancestors1986: 2 other ancestors1985: 2 other ancestors1984: 2 other ancestors1981: 2 other ancestors2023: 1 descendant cleared2022: 1 descendant cleared×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) ×2: 2 generations cleared close together, K121680 (2012), K122862 (2012) K141605 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K143375 · CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments · Medtronic Sofamor Danek USA, Inc. · 2015K153203 · Navigation Instruments · Globus Medical, Inc. · 2016K161591 · QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments · Globus Medical, Inc. · 2016K171651 · Excelsius GPS · Globus Medical, Inc. · 2017 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 17 other ancestors3 generations back: 46 other ancestors4 generations back: 81 other ancestors, 1 with a Class I recall15 generations back: 133 other ancestors6 generations back: 78 other ancestors7 generations back: 42 other ancestors8 generations back: 26 other ancestors9 generations back: 14 other ancestors10 generations back: 5 other ancestors11 generations back: 4 other ancestors12 generations back: 2 other ancestors 1 generation forward: 2 descendants K171651 · Excelsius GPS · Globus Medical, Inc. · 2017 · recalledK161591 · QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments · Globus Medical, Inc. · 2016K153203 · Navigation Instruments · Globus Medical, Inc. · 2016K143375 · CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments · Medtronic Sofamor Danek USA, Inc. · 2015K141605 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K122862 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−15−10−50
  1. Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 15 generations between
  3. 3 generations backK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
  4. 2 generations backK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
  5. 1 generation backK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
  6. This deviceK183119 SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments…Globus Medical, Inc. · 2019
  7. Descendant · cites it directly · 0 of its ownK231923 Liberty SI Lateral Implant SystemSpinal Simplicity, LLC · 2023
  8. Descendant · cites it directly · 0 of its ownK212962 TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC · 2022
Show all 19 generations
  1. Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 18 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 17 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 16 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 15 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 14 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 13 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 12 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 11 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 10 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 9 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 8 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 7 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 6 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  15. 5 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  16. 4 generations backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
  17. 3 generations backK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
  18. 2 generations backK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
  19. 1 generation backK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
  20. This deviceK183119 SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments…Globus Medical, Inc. · 2019

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System4 generations back · 2010

Most influential descendants

Showing 2 of 2 · See all
  • K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC · 2023 · cites it directly0descendants
  • K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−19K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−18K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−17K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−16K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−15K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−14K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−13K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−12K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−11K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−10K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−9K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−8K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−7K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−6K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−5K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−4K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015—
−3K153203Navigation InstrumentsGlobus Medical, Inc.2016—
−2K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.2016—
−1K171651Excelsius GPSGlobus Medical, Inc.20171
0 (this device)K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments…Globus Medical, Inc.2019—
+1K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC2023—
+1K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
197910
198120
198420
198520
198620
198730
198820
198950
199020
199120
199230
199340
199470
1995160
1996170
1997120
1998170
1999190
2000260
2001370
2002250
2003250
2004420
2005360
2006230
2007150
2008270
2009150
2010151
2011160
201270
201390
201450
201570
201620
201710
201810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
202310
FIG. 1 — Lineage of K183119, 2004–2023Source: 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.

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 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? (7)

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
*K112028SI-Lok Sacroiliac Joint Fixation System
Summary page 6
…ic Instruments Product Codes OLO Regulatory Class: II, Panel Code: 87 Primary Predicate: SI-LOK® Sacroiliac Joint Fixation System (K112028) Additional Predicates: Synthes Cannulated Screw System (K962011, K021932) Medtronic RIALTO (K161210)…
Globus Medical, Inc.2011—
*K962011Synthes 7.0/7.3 MM Cannulated Screws
Summary page 6
…gulatory Class: II, Panel Code: 87 Primary Predicate: SI-LOK® Sacroiliac Joint Fixation System (K112028) Additional Predicates: Synthes Cannulated Screw System (K962011, K021932) Medtronic RIALTO (K161210)…
Synthes (Usa)1996—
*K021932Synthes 6.5 MM Cannulated Screw
Summary page 6
…Class: II, Panel Code: 87 Primary Predicate: SI-LOK® Sacroiliac Joint Fixation System (K112028) Additional Predicates: Synthes Cannulated Screw System (K962011, K021932) Medtronic RIALTO (K161210)…
Synthes (Usa)20027
*K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…
Summary page 6
…SI-LOK® Sacroiliac Joint Fixation System (K112028) Additional Predicates: Synthes Cannulated Screw System (K962011, K021932) Medtronic RIALTO (K161210) K183119…
Medtronic Sofamor Danek2016—
*K171651Excelsius GPS
Summary page 7
…Page 2 of 3 SI-LOK® ExcelsiusGPS® Instruments ExcelsiusGPS® (K171651) SI-LOK® Navigation Instruments Navigation Instruments (K153203, K180690) Purpose: Th…
Globus Medical, Inc.20171
*K153203Navigation Instruments
Summary page 7
…ExcelsiusGPS® Instruments ExcelsiusGPS® (K171651) SI-LOK® Navigation Instruments Navigation Instruments (K153203, K180690) Purpose: The purpose of this submission is to request clearance of additional SI-LOK® Select implants, ExcelsiusGPS® I…
Globus Medical, Inc.2016—
*K180690Navigation Instruments
Summary page 7
…sGPS® Instruments ExcelsiusGPS® (K171651) SI-LOK® Navigation Instruments Navigation Instruments (K153203, K180690) Purpose: The purpose of this submission is to request clearance of additional SI-LOK® Select implants, ExcelsiusGPS® Instrument…
Globus Medical, Inc.2018—

Also cleared against K112028: 15 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230
K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220

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.

  • K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 7 months on median.
  • 65 of the 472 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K231923 (Spinal Simplicity, LLC, 2023) has gone furthest, with 0 descendants of its own.
  • 15 other devices also cite its predicate K112028.

How does its category compare?

All OUR devices

OUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 SI-LOK® Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX®, CREO®, REVERE®, REVOLVE®, ELLIPSE®, PROTEX® CT, and SI-LOK®) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or…

Read the full statement (205 words)

The SI-LOK® Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX®, CREO®, REVERE®, REVOLVE®, ELLIPSE®, PROTEX® CT, and SI-LOK®) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K112028

15 other devices cite the same predicate.

  • K230446TiLink-L SI Joint Fusion SystemSurGenTec, LLC · 2023
  • K190580NADIA SI Fusion SystemIlion Medical, Inc. · 2020
  • K182919SI-Restore® Sacroiliac Joint Fixation SystemBiofusion Medical · 2019
  • K181881Outlet Sacroiliac Joint Fusion SystemSij Surgical · 2018
  • K173201UNITY Sacroiliac Joint Fixation SystemHuvexel Co., Ltd. · 2018
  • K171651Excelsius GPSGlobus Medical, Inc. · 20171 recall

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 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/K183119 · printed Nov 6, 2026

Cite this page

510(k) Report. “K183119: SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183119

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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