510(k) Report

510(k) · Cleared

Cleared

Excelsius3D

K210912510(k) TraditionalCleared Aug 12, 2021136-day reviewClass II21 CFR 892.1650

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Globus Medical, Inc. · OWB Interventional Fluoroscopic X-Ray System

Cleared on Aug 12, 2021 as substantially equivalent to K092564 (Medtronic Navigation, Inc. (Littleton), 2010) and 1 other predicate after a 136-day review. Its family tree reaches back 8 generations to 2000. 2 of the 21 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it.

Decided
Aug 12, 2021
Review
136 days
Class
Class II
Product code
OWB
Recalls
None
Predicates
2

Its longest line of descent runs back 8 generations to K003266 (2000). 10 ancestors in all. 10 later devices descend from it, 1 citing it directly. 2 of the 21 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors, 1 with a Class I recall12021: 1 descendant cleared, 1 with a Class I recall12025: 3 descendants cleared2024: 5 descendants cleared2026: 1 descendant clearedReference device: K142383 · Optima XR200amx, Optima XR220amx · Ge Medical Systems, LLC · 2014 · recalledK003266 · Siremobil Iso-C 3D · Siemens Medical Solutions USA, Inc. · 2000K032280 · Siremobil Iso-C 3D · Siemens AG · 2003K050996 · O-Arm Imaging System · Breakaway Imaging, LLC · 2005 · recalledK060344 · O-Arm Imaging System · Breakaway Imaging, LLC · 2006 · recalledK092564 · O-Arm Imaging System · Medtronic Navigation, Inc. (Littleton) · 2010 · recalledK151000 · O-Arm O2 Imaging System · Medtronic, Inc. · 2015 · recalledK173664 · Medtronic O-arm O2 Imaging System · Medtronic, Inc. · 2017 · recalledK200074 · O-arm O2 Imaging System · Medtronic, Inc. · 2020200020052010201520202025
Other ancestors, by generationDescendants, by generation 4 generations back: 2 other ancestors, 1 with a Class I recall1 1 generation forward: 1 descendant, 1 with a Class I recall12 generations forward: 7 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K200074 · O-arm O2 Imaging System · Medtronic, Inc. · 2020K173664 · Medtronic O-arm O2 Imaging System · Medtronic, Inc. · 2017 · recalledK151000 · O-Arm O2 Imaging System · Medtronic, Inc. · 2015 · recalledK092564 · O-Arm Imaging System · Medtronic Navigation, Inc. (Littleton) · 2010 · recalledK060344 · O-Arm Imaging System · Breakaway Imaging, LLC · 2006 · recalledK050996 · O-Arm Imaging System · Breakaway Imaging, LLC · 2005 · recalledK032280 · Siremobil Iso-C 3D · Siemens AG · 2003K003266 · Siremobil Iso-C 3D · Siemens Medical Solutions USA, Inc. · 2000−50
  1. Root · 8 generations backK003266 Siremobil Iso-C 3DSiemens Medical Solutions USA, Inc. · 2000
  2. 7 generations backK032280 Siremobil Iso-C 3DSiemens AG · 2003
  3. 6 generations backK050996 O-Arm Imaging SystemBreakaway Imaging, LLC · 2005 · Recalled
  4. 5 generations backK060344 O-Arm Imaging SystemBreakaway Imaging, LLC · 2006 · Recalled
  5. 4 generations backK092564 O-Arm Imaging SystemMedtronic Navigation, Inc. (Littleton) · 2010 · Recalled
  6. 3 generations backK151000 O-Arm O2 Imaging SystemMedtronic, Inc. · 2015 · Recalled
  7. 2 generations backK173664 Medtronic O-arm O2 Imaging SystemMedtronic, Inc. · 2017 · Recalled
  8. 1 generation backK200074 O-arm O2 Imaging SystemMedtronic, Inc. · 2020
  9. This deviceK210912 Excelsius3DGlobus Medical, Inc. · 2021
  10. Descendant · cites it directly · 9 of its ownK211616 ExcelsiusHubGlobus Medical, Inc. · 2021 · Recalled (Class I)
  11. Descendant · 2 generations on · 2 of its ownK231850 QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS®…Globus Medical, Inc. · 2024
  12. Descendant · 3 generations on · 1 of its ownK252327 CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG · 2025
  13. Descendant · 2 generations on · 1 of its ownK233638 VERZA™ High Speed DrillsGlobus Medical, Inc. · 2024
  14. Descendant · 4 generations on · 0 of its ownK254045 CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid…CarboFix Orthopedics, Ltd. · 2026

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2021: 12024: 52025: 32026: 1
2021high 5 (2024) · low 0 (2022)2026

Class I recalls in this family

  • K003837 Flexiview 8800 Digital Mobile Imaging System4 generations back · 2001
  • K211616 ExcelsiusHubcites it directly · 2021

Most influential descendants

Showing 5 of 10 · See all
  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · cites it directly9descendants
  • K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc. · 2024 · 2 generations on2descendants
  • K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG · 2025 · 3 generations on1descendant
  • K233638VERZA™ High Speed DrillsGlobus Medical, Inc. · 2024 · 2 generations on1descendant
  • K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K003266Siremobil Iso-C 3DSiemens Medical Solutions USA, Inc.2000—
−7K032280Siremobil Iso-C 3DSiemens AG2003—
−6K050996O-Arm Imaging SystemBreakaway Imaging, LLC20054
−5K060344O-Arm Imaging SystemBreakaway Imaging, LLC20061
−4K092564O-Arm Imaging SystemMedtronic Navigation, Inc. (Littleton)201018
−3K151000O-Arm O2 Imaging SystemMedtronic, Inc.20157
−2K173664Medtronic O-arm O2 Imaging SystemMedtronic, Inc.20172
−1K200074O-arm O2 Imaging SystemMedtronic, Inc.2020—
0 (this device)K210912Excelsius3DGlobus Medical, Inc.2021—
+1K211616ExcelsiusHubGlobus Medical, Inc.2021Class I
+2K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.2024—
+3K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG2025—
+2K233638VERZA™ High Speed DrillsGlobus Medical, Inc.2024—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior…CarboFix Orthopedics, Ltd.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200121

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202111
202450
202530
202610
FIG. 1 — Lineage of K210912, 2000–2026Source: 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.

2 devices in this family have 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 OWB device

  1. #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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? (2)

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
*K092564O-Arm Imaging System
Summary page 4
…Mobile Product Code(s): OWB, OXO, JAA Regulatory Class: II Primary Predicate: Medtronic O-Arm Imaging System (K092564) Other Predicates: Medtronic O-Arm O2 Imaging System (K200074) Reference Device: GE Optima XR220amx/XR200amx (K142383) Purpose:…
Medtronic Navigation, Inc. (Littleton)201018
*K200074O-arm O2 Imaging System
Summary page 4
…OWB, OXO, JAA Regulatory Class: II Primary Predicate: Medtronic O-Arm Imaging System (K092564) Other Predicates: Medtronic O-Arm O2 Imaging System (K200074) Reference Device: GE Optima XR220amx/XR200amx (K142383) Purpose: The purpose of this submission is to request clearance of the…
Medtronic, Inc.2020—
†K142383Optima XR200amx, Optima XR220amxGe Medical Systems, LLC20148

Also cleared against K092564: 1 other device →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K211616ExcelsiusHub Class IGlobus Medical, Inc.20219

Has anything in its family been recalled? (2 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.

  • K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 4 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · Cites it directly · ◆ 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 6 companies; a new generation was cleared every 2.4 years on median.
  • 7 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K211616 (Globus Medical, Inc., 2021) has gone furthest, with 9 descendants of its own.
  • 1 other device also cites its predicate K092564.

How does its category compare?

All OWB devices

OWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · OWB

22in 2025

2007: 32008: 42009: 92010: 72011: 62012: 62013: 112014: 152015: 112016: 162017: 202018: 232019: 92020: 162021: 242022: 212023: 122024: 132025: 222026 (partial year): 15
2007high 24 (2021) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OWB

148in 2025

2007: 52 days median2008: 135 days median2009: 99 days median2010: 66 days median2011: 79 days median2012: 37 days median2013: 119 days median2014: 158 days median2015: 66 days median2016: 103 days median2017: 76 days median2018: 54 days median2019: 174 days median2020: 53 days median2021: 60 days median2022: 90 days median2023: 152 days median2024: 126 days median2025: 148 days median2026 (partial year): 221 days median
2007high 221 (2026) · low 37 (2012)2026

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

Recalls per year · OWB

42so far in 2026, the most since 2007

2008: 12013: 102014: 92015: 352016: 132017: 132018: 62019: 72020: 82021: 312022: 242023: 222024: 112025: 302026 (partial year): 42
2007high 42 (2026) · low 0 (2007)2026

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

Adverse event reports per year · OWB

14,008in 2025

2007: 12011: 12012: 12013: 272014: 1032015: 2,1342016: 4,0742017: 1,6042018: 1,4492019: 1,5582020: 1,5812021: 1,9812022: 2,9322023: 7,6042024: 7,9422025: 14,008
2007high 14,008 (2025) · low 0 (2008)2025

MAUDE reports naming product code OWB, 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
200735201
2008413510
200999900
201076600
201167901
201263701
2013111191027
2014151589103
20151166352,134
201616103134,074
20172076131,604
2018235461,449
2019917471,558
2020165381,581
20212460311,981
20222190242,932
202312152227,604
202413126117,942
2025221483014,008
20261522142—

What is it indicated for?

Excelsius3D™ is a mobile X-ray system designed for 2D fluoroscopy, 2D digital radiography, and 3D imaging of adult and pediatric patients. The system is indicated for use where a physician benefits from 2D and 3D information on anatomic structures and high contrast objects with high x-ray attenuation such as bony anatomy and metallic objects. Excelsius3D™ images are compatible with image guided systems such as ExcelsiusGPS®.

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 K092564

1 other device cites the same predicate.

  • K151000O-Arm O2 Imaging SystemMedtronic, Inc. · 20157 recalls

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 OWB

The OWB category page

  • K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd. · 2026
  • K261413Extron 3;Extron 6DRTECH Corporation · 2026
  • K254205Zenition 30Philips Medical Systems Nederland B.V. · 2026
  • K260607Shield System (Siemens 30x40)Radiaction, Ltd. · 2026
  • K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V. · 2026

https://510kreport.com/device/K210912 · printed Nov 4, 2026

Cite this page

510(k) Report. “K210912: Excelsius3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210912

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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