510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Excelsius GPS

K171651510(k) TraditionalCleared Aug 16, 201772-day reviewClass II21 CFR 882.4560Recalls 1

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 Aug 16, 2017 as substantially equivalent to K133444 (Medtronic Navigation, Inc., 2014) and 8 other predicates after a 72-day review. Its family tree reaches back 18 generations to 2004. 2 of the 496 devices in its family, counting itself, have a Class I recall. 69 later devices descend from it. It has been recalled once.

Decided
Aug 16, 2017
Review
72 days
Class
Class II
Product code
OLO
Recalls
1
Predicates
9

Its longest line of descent runs back 18 generations to K040583 (2004). 426 ancestors in all, the oldest K781443 (1978). 69 later devices descend from it, 28 citing it directly. 2 of the 496 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2017: 1 other ancestor2016: 1 other ancestor2015: 6 other ancestors2014: 5 other ancestors2013: 6 other ancestors2011: 13 other ancestors2012: 5 other ancestors2010: 14 other ancestors, 1 with a Class I recall12009: 15 other ancestors2008: 24 other ancestors2006: 23 other ancestors2005: 34 other ancestors2002: 22 other ancestors1999: 16 other ancestors1998: 17 other ancestors1996: 15 other ancestors2007: 13 other ancestors2004: 36 other ancestors2003: 21 other ancestors2001: 32 other ancestors2000: 26 other ancestors1993: 3 other ancestors1990: 2 other ancestors1997: 12 other ancestors1995: 15 other ancestors1979: 1 other ancestor1978: 1 other ancestor1994: 7 other ancestors1989: 5 other ancestors1987: 3 other ancestors1985: 2 other ancestors1981: 2 other ancestors1992: 3 other ancestors1991: 1 other ancestor1988: 2 other ancestors1984: 2 other ancestors1986: 2 other ancestors2019: 3 descendants cleared2021: 4 descendants cleared, 1 with a Class I recall12025: 15 descendants cleared2024: 15 descendants cleared2026: 18 descendants cleared2023: 8 descendants cleared2020: 1 descendant cleared2022: 5 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. · 2015K153203 · Navigation Instruments · Globus Medical, Inc. · 2016K161591 · QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments · Globus Medical, Inc. · 201619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors2 generations back: 30 other ancestors3 generations back: 58 other ancestors, 1 with a Class I recall14 generations back: 101 other ancestors5 generations back: 75 other ancestors6 generations back: 51 other ancestors7 generations back: 45 other ancestors8 generations back: 21 other ancestors9 generations back: 8 other ancestors10 generations back: 9 other ancestors11 generations back: 2 other ancestors 1 generation forward: 28 descendants, 1 with a Class I recall12 generations forward: 14 descendants3 generations forward: 13 descendants4 generations forward: 9 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant7 generations forward: 1 descendant K161591 · 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+5
  1. Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 14 generations between
  3. 3 generations backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
  4. 2 generations backK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
  5. 1 generation backK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
  6. This deviceK171651 Excelsius GPSGlobus Medical, Inc. · 2017
  7. Descendant · cites it directly · 42 of its ownK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
  8. Descendant · 2 generations on · 23 of its ownK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
  9. Descendant · cites it directly · 9 of its ownK211616 ExcelsiusHubGlobus Medical, Inc. · 2021 · Recalled (Class I)
  10. Descendant · cites it directly · 7 of its ownK220862 E-GPS Navigated InstrumentsPrecision Spine, Inc. · 2022
  11. Descendant · 3 generations on · 6 of its ownK241846 E3D™-C Interbody SystemEvolution Spine · 2024
Show all 18 generations
  1. Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 17 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 16 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 15 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 14 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 13 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 12 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 11 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 10 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 9 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 8 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 7 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 6 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 5 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  15. 4 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  16. 3 generations backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
  17. 2 generations backK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
  18. 1 generation backK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
  19. This deviceK171651 Excelsius GPSGlobus Medical, Inc. · 2017

Showing 5 of 69 descendants. See all descendants

Descendants cleared per year

2019: 32020: 12021: 42022: 52023: 82024: 152025: 152026: 18
2019high 18 (2026) · low 1 (2020)2026

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System3 generations back · 2010
  • K211616 ExcelsiusHubcites it directly · 2021

Most influential descendants

Showing 5 of 69 · See all
  • K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019 · cites it directly42descendants
  • K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc. · 2022 · 2 generations on23descendants
  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · cites it directly9descendants
  • K220862E-GPS Navigated InstrumentsPrecision Spine, Inc. · 2022 · cites it directly7descendants
  • K241846E3D™-C Interbody SystemEvolution Spine · 2024 · 3 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−18K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−17K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−16K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−15K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−14K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−13K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−12K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−11K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−10K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−9K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−8K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−7K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−6K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−5K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−4K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−3K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015—
−2K153203Navigation InstrumentsGlobus Medical, Inc.2016—
−1K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.2016—
0 (this device)K171651Excelsius GPSGlobus Medical, Inc.2017—
+1K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.2019—
+2K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer…Globus Medical, Inc.2022—
+1K211616ExcelsiusHubGlobus Medical, Inc.2021Class I
+1K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.2022—
+3K241846E3D™-C Interbody SystemEvolution Spine2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
197910
198120
198420
198520
198620
198730
198820
198950
199020
199110
199230
199330
199470
1995150
1996150
1997120
1998170
1999160
2000260
2001320
2002220
2003210
2004360
2005340
2006230
2007130
2008240
2009150
2010141
2011130
201250
201360
201450
201560
201610
201710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201930
202010
202141
202250
202380
2024150
2025150
2026180
FIG. 1 — Lineage of K171651, 2004–2026Source: 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.

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 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? (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
*K133444Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System
Summary page 4
…Product Code(s): OLO Regulatory Class: II Predicates: EXCELSIUS GPS™ Primary predicate: StealthStation (K133444) Additional predicate: ROSA Spine (K151511) EXCELSIUS GPS™ Instruments…
Medtronic Navigation, Inc.20141
*K151511ROSA Spine
Summary page 4
…gulatory Class: II Predicates: EXCELSIUS GPS™ Primary predicate: StealthStation (K133444) Additional predicate: ROSA Spine (K151511) EXCELSIUS GPS™ Instruments Additional predicates: CREO® (K143633)…
Medtech S.A20163
*K143633CREO Stabilization System
Summary page 4
…Additional predicate: ROSA Spine (K151511) EXCELSIUS GPS™ Instruments Additional predicates: CREO® (K143633) REVERE® (K133350) REVOLVE® (K111449) QUARTEX™ (K161591)…
Globus Medical, Inc.2015—
*K133350Revere Stabilization System
Summary page 4
…A Spine (K151511) EXCELSIUS GPS™ Instruments Additional predicates: CREO® (K143633) REVERE® (K133350) REVOLVE® (K111449) QUARTEX™ (K161591) ELLIPSE® (K123783)…
Globus Medical, Inc.2014—
*K111449Revolve Additional Implants
Summary page 4
…EXCELSIUS GPS™ Instruments Additional predicates: CREO® (K143633) REVERE® (K133350) REVOLVE® (K111449) QUARTEX™ (K161591) ELLIPSE® (K123783) SI-LOK® (K112028)…
Globus Medical, Inc.2011—
*K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
Summary page 4
…Additional predicates: CREO® (K143633) REVERE® (K133350) REVOLVE® (K111449) QUARTEX™ (K161591) ELLIPSE® (K123783) SI-LOK® (K112028) CAPTIVATE™ (K162825) Purpose: The…
Globus Medical, Inc.2016—
*K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants
Summary page 4
…CREO® (K143633) REVERE® (K133350) REVOLVE® (K111449) QUARTEX™ (K161591) ELLIPSE® (K123783) SI-LOK® (K112028) CAPTIVATE™ (K162825) Purpose: The purpose of this submission is to reque…
Globus Medical, Inc.2013—
*K112028SI-Lok Sacroiliac Joint Fixation System
Summary page 4
…REVERE® (K133350) REVOLVE® (K111449) QUARTEX™ (K161591) ELLIPSE® (K123783) SI-LOK® (K112028) CAPTIVATE™ (K162825) Purpose: The purpose of this submission is to request clearance of EXCELSIUS GPS™ and EX…
Globus Medical, Inc.2011—
*K162825CAPTIVATE™ Compression Screws
Summary page 4
…REVOLVE® (K111449) QUARTEX™ (K161591) ELLIPSE® (K123783) SI-LOK® (K112028) CAPTIVATE™ (K162825) Purpose: The purpose of this submission is to request clearance of EXCELSIUS GPS™ and EXCELSIUS GPS™ Instruments. Device Descri…
Globus Medical, Inc.2017—

Also cleared against K133444: 8 other devices →

What descends from it? (69)

See all 69

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

NumberDeviceApplicantDecidedDescendants
K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942
K211616ExcelsiusHub Class IGlobus Medical, Inc.20219
K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227
K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215
K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.20205
K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233
K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242
K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242
K201569CUVIS-spineCurexo, Inc.20212
K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192

Has anything in its family been recalled? (2 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 15, 2023Class IIZ-1007-2024Device DesignDevices may not be rendered sterile due to an internal gap that may be present on some devices causing increased difficulty cleaning prior to steam sterilization. There is an increased risk for infection, inflammation, local toxicity…

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 · 3 generations back · ◆ in the 2010 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 13 years and passes through 4 companies; a new generation was cleared every 7 months on median.
  • 58 of the 426 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K191100 (Globus Medical, Inc., 2019) has gone furthest, with 42 descendants of its own.
  • 8 other devices also cite its predicate K133444.

How does its category compare?

All OLO devices

OLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?

The EXCELSIUS GPS™ 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 K133444

8 other devices cite the same predicate.

  • K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.) · 2022
  • K190556Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc. · 2019
  • K180523INTAI Surgery Navigation SystemIntai Technology Corporation · 2019
  • K1810417D Surgical System Cranial Application7D Surgical, Inc. · 2018
  • K1803527D Surgical System7D Surgical, Inc. · 2018
  • K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 20172 Class I 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 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/K171651 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171651: Excelsius GPS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171651

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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