510(k) Report

510(k) · Cleared

Cleared

Navigation Instruments

K153203510(k) TraditionalCleared Feb 3, 201691-day reviewClass II21 CFR 882.4560

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

Globus Medical, Inc. · OLO Orthopedic Stereotaxic Instrument

Cleared on Feb 3, 2016 as substantially equivalent to K143628 (Medtronic Sofamor Danek USA, Inc., 2015) and 2 other predicates after a 91-day review. Its family tree reaches back 16 generations to 2004. 1 of the 265 devices in its family, counting itself, has a Class I recall. 112 later devices descend from it.

Decided
Feb 3, 2016
Review
91 days
Class
Class II
Product code
OLO
Recalls
None
Predicates
3

Its longest line of descent runs back 16 generations to K040583 (2004). 152 ancestors in all, the oldest K841189 (1984). 112 later devices descend from it, 11 citing it directly. 1 of the 265 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2015: 1 other ancestor2014: 2 other ancestors2013: 3 other ancestors2012: 1 other ancestor2011: 2 other ancestors2010: 2 other ancestors2009: 1 other ancestor2008: 5 other ancestors2006: 8 other ancestors2005: 14 other ancestors2004: 19 other ancestors2003: 8 other ancestors2007: 3 other ancestors2002: 8 other ancestors2001: 9 other ancestors2000: 11 other ancestors1999: 3 other ancestors1997: 5 other ancestors1996: 2 other ancestors1994: 4 other ancestors1998: 6 other ancestors1995: 7 other ancestors1988: 2 other ancestors1987: 1 other ancestor1984: 2 other ancestors1992: 2 other ancestors1989: 1 other ancestor1986: 2 other ancestors1985: 1 other ancestor1990: 1 other ancestor2019: 6 descendants cleared2018: 6 descendants cleared2016: 1 descendant cleared2020: 7 descendants cleared2021: 9 descendants cleared, 1 with a Class I recall12017: 3 descendants cleared2024: 21 descendants cleared2022: 9 descendants cleared2026: 19 descendants cleared2023: 13 descendants cleared2025: 18 descendants 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. · 201519801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 6 other ancestors3 generations back: 21 other ancestors4 generations back: 38 other ancestors5 generations back: 34 other ancestors6 generations back: 13 other ancestors7 generations back: 8 other ancestors8 generations back: 14 other ancestors 1 generation forward: 11 descendants2 generations forward: 21 descendants3 generations forward: 41 descendants, 1 with a Class I recall14 generations forward: 15 descendants5 generations forward: 11 descendants6 generations forward: 8 descendants7 generations forward: 3 descendants8 generations forward: 1 descendant9 generations forward: 1 descendant K143375 · 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+5
  1. Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 12 generations between
  3. 3 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  4. 2 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  5. 1 generation backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
  6. This deviceK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
  7. Descendant · cites it directly · 78 of its ownK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
  8. Descendant · 2 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
  9. Descendant · 3 generations on · 42 of its ownK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
  10. Descendant · 4 generations on · 23 of its ownK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
  11. Descendant · 3 generations on · 9 of its ownK211616 ExcelsiusHubGlobus Medical, Inc. · 2021 · Recalled (Class I)
Show all 16 generations
  1. Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 15 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 14 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 13 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 12 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 11 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 10 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 9 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 8 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 7 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 6 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 5 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 4 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 3 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  15. 2 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  16. 1 generation backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
  17. This deviceK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016

Showing 5 of 112 descendants. See all descendants

Descendants cleared per year

2016: 12017: 32018: 62019: 62020: 72021: 92022: 92023: 132024: 212025: 182026: 19
2016high 21 (2024) · low 1 (2016)2026

Class I recalls in this family

  • K211616 ExcelsiusHub3 generations on · 2021

Most influential descendants

Showing 5 of 112 · See all
  • K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. · 2016 · cites it directly78descendants
  • K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 2 generations on69descendants
  • K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019 · 3 generations on42descendants
  • K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc. · 2022 · 4 generations on23descendants
  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 3 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−15K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−14K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−13K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−12K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−11K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−10K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−9K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−8K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−7K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−6K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−5K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−4K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−3K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−2K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−1K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015—
0 (this device)K153203Navigation InstrumentsGlobus Medical, Inc.2016—
+1K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.2016—
+2K171651Excelsius GPSGlobus Medical, Inc.20171
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.2019—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer…Globus Medical, Inc.2022—
+3K211616ExcelsiusHubGlobus Medical, Inc.2021Class I

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198420
198510
198620
198710
198820
198910
199010
199220
199440
199570
199620
199750
199860
199930
2000110
200190
200280
200380
2004190
2005140
200680
200730
200850
200910
201020
201120
201210
201330
201420
201510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201730
201860
201960
202070
202191
202290
2023130
2024210
2025180
2026190
FIG. 1 — Lineage of K153203, 2004–2026Source: 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 OLO device

  1. #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 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? (3)

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
*K143628Navigated Vertex Select Instruments
Summary page 4
…2.4560 Stereotaxic Instrument Product Code: OLO Regulatory Class: II, Panel Code: 84 Primary Predicate: Medtronic instruments (K143628, K143375, K140454) Purpose: The purpose of this submission is to request clearance for the Globus Navigation Instruments for use…
Medtronic Sofamor Danek USA, Inc.2015—
*K143375CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments
Summary page 4
…ereotaxic Instrument Product Code: OLO Regulatory Class: II, Panel Code: 84 Primary Predicate: Medtronic instruments (K143628, K143375, K140454) Purpose: The purpose of this submission is to request clearance for the Globus Navigation Instruments for use with the…
Medtronic Sofamor Danek USA, Inc.2015—
*K140454Navigated CD Horizon Solera Screwdriver/Taps
Summary page 4
…Instrument Product Code: OLO Regulatory Class: II, Panel Code: 84 Primary Predicate: Medtronic instruments (K143628, K143375, K140454) Purpose: The purpose of this submission is to request clearance for the Globus Navigation Instruments for use with the Medtroni…
Medtronic Sofamor Danek USA, Inc.20141

Also cleared against K143628: 19 other devices →

What descends from it? (112)

See all 112

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

NumberDeviceApplicantDecidedDescendants
K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678
K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209
K180690Navigation InstrumentsGlobus Medical, Inc.20189
K183630SPINEART Navigation Instrument SystemSpineart SA20196
K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176
K182731Corelink Navigation InstrumentsCorelink, LLC20195
K172518Spineology Navigation InstrumentsSpineology, Inc.20184
K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192
K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182
K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211

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 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 5 months on median.
  • 21 of the 152 ancestors have a recall of any class.
  • Of its descendants, K161591 (Globus Medical, Inc., 2016) has gone furthest, with 78 descendants of its own.
  • 19 other devices also cite its predicate K143628.

How does its category compare?

All OLO devices

OLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · OLO

40in 2025

2009: 112010: 92011: 112012: 72013: 72014: 102015: 102016: 142017: 332018: 242019: 352020: 342021: 282022: 402023: 452024: 442025: 402026 (partial year): 42
2007high 45 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLO

119in 2025

2009: 126 days median2010: 113 days median2011: 138 days median2012: 129 days median2013: 137 days median2014: 119 days median2015: 176 days median2016: 120 days median2017: 91 days median2018: 97 days median2019: 95 days median2020: 89 days median2021: 91 days median2022: 89 days median2023: 90 days median2024: 90 days median2025: 119 days median2026 (partial year): 109 days median
2007high 176 (2015) · low 89 (2020)2026

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

Recalls per year · OLO

1in 2025

2010: 12011: 12012: 12014: 32015: 22016: 32017: 22018: 12019: 12020: 62022: 52023: 7, 1 Class I2024: 42025: 12026 (partial year): 6
2007high 7 (2023) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · OLO

3,306in 2025

2008: 12009: 42010: 42011: 102012: 602013: 362014: 2452015: 4662016: 7502017: 1,0762018: 1,2302019: 1,5852020: 2,7462021: 1,6962022: 1,5682023: 1,4932024: 2,3532025: 3,306
2007high 3,306 (2025) · low 0 (2007)2025

MAUDE reports naming product code OLO, 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
20080—01
20091112604
2010911314
201111138110
20127129160
20137137036
2014101193245
2015101762466
2016141203750
2017339121,076
2018249711,230
2019359511,585
2020348962,746
2021289101,696
2022408951,568
202345907 (1)1,493
2024449042,353
20254011913,306
2026421096—

What is it indicated for?

Globus Navigation Instruments are intended to be used in the preparation and placement of Globus screws (CREO, REVERE, REVOLVE, ELLIPSE and PROTEX CT Stabilization Systems) 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…

Read the full statement (108 words)

Globus Navigation Instruments are intended to be used in the preparation and placement of Globus screws (CREO, REVERE, REVOLVE, ELLIPSE and PROTEX CT Stabilization Systems) 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 MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Indications for use as stated in the FDA summary.

Also cleared against K143628

19 other devices cite the same predicate.

  • K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC · 2026
  • K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc. · 2026
  • K230369EUROPA™ Navigated InstrumentsMiRus, LLC · 2023
  • K223200Curiteva Navigation SystemCuriteva, Inc. · 2023
  • K220024ChoiceSpine Navigation SystemChoice Spine, LLC · 2022
  • K212007VERTICALE Navigation InstrumentsSilony Medical GmbH · 2021

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 OLO

The OLO category page

  • K2604037D Surgical System (10-0001)7D Surgical ULC · 2026
  • K263234TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2026
  • K263154CarboClear® Cervical Navigated InstrumentsCarboFix Orhtopedics, Ltd. · 2026
  • K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE · 2026
  • K262506Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp. · 2026

https://510kreport.com/device/K153203 · printed Nov 4, 2026

Cite this page

510(k) Report. “K153203: Navigation Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K153203

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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