510(k) · Cleared
Recalled · Class II · 2023ExcelsiusGPS Cranial 1.0 Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Jul 10, 2020 as substantially equivalent to K171651 (Globus Medical, Inc., 2017) and 3 other predicates after a 183-day review. Its family tree reaches back 20 generations to 2004. 7 of the 696 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 10, 2020
- Review
- 183 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 20 generations to K040583 (2004). 690 ancestors in all, the oldest K781443 (1978). 5 later devices descend from it, 2 citing it directly. 7 of the 696 devices in this family, counting this one, have a Class I recall.
- Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations between
- 3 generations backK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
- 2 generations backK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- 1 generation backK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
- This deviceK200047 ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK231850 QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS®…Globus Medical, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK252327 CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG · 2025
- Descendant · cites it directly · 1 of its ownK203153 CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK253739 SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization…Globus Medical, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK254045 CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid…CarboFix Orthopedics, Ltd. · 2026
Show all 20 generations
- Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 19 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 17 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 16 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 15 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 14 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 13 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 12 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 11 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 10 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 9 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 8 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 7 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 6 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 5 generations backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 4 generations backK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
- 3 generations backK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
- 2 generations backK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- 1 generation backK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
- This deviceK200047 ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc. · 2020
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc. · 2024 · cites it directly2descendants
- K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG · 2025 · 2 generations on1descendant
- K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc. · 2021 · cites it directly1descendant
- K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc. · 2026 · 2 generations on0descendants
- K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −19 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −18 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −17 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −16 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −15 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −14 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −13 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −12 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −11 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −10 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −9 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −8 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −7 | K122862 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −6 | K141605 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −5 | K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −4 | K153203 | Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| −3 | K161591 | QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| −2 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| −1 | K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019 | — |
| 0 (this device) | K200047 | ExcelsiusGPS Cranial 1.0 Module | Globus Medical, Inc. | 2020 | — |
| +1 | K231850 | QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments | Globus Medical, Inc. | 2024 | — |
| +2 | K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments | Icotec AG | 2025 | — |
| +1 | K203153 | CREO Stabilization System, Navigation Instruments, ExcelsiusGPS | Globus Medical, Inc. | 2021 | — |
| +2 | K253739 | SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System… | Globus Medical, Inc. | 2026 | — |
| +3 | K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior… | CarboFix Orthopedics, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 2 | 0 |
| 1980 | 1 | 0 |
| 1981 | 2 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 3 | 0 |
| 1988 | 2 | 0 |
| 1989 | 5 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 4 | 0 |
| 1994 | 7 | 0 |
| 1995 | 15 | 0 |
| 1996 | 17 | 0 |
| 1997 | 12 | 0 |
| 1998 | 18 | 0 |
| 1999 | 21 | 0 |
| 2000 | 26 | 0 |
| 2001 | 40 | 0 |
| 2002 | 32 | 0 |
| 2003 | 39 | 0 |
| 2004 | 63 | 0 |
| 2005 | 49 | 0 |
| 2006 | 34 | 0 |
| 2007 | 30 | 0 |
| 2008 | 62 | 0 |
| 2009 | 35 | 0 |
| 2010 | 32 | 1 |
| 2011 | 33 | 0 |
| 2012 | 15 | 0 |
| 2013 | 21 | 0 |
| 2014 | 13 | 0 |
| 2015 | 15 | 2 |
| 2016 | 3 | 1 |
| 2017 | 4 | 1 |
| 2018 | 1 | 1 |
| 2019 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
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.
7 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 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K171651 | Excelsius GPSSummary page 4…§882.4560 Stereotaxic instrument Product Code(s): OLO, HAW Regulatory Class: II Primary Predicate: ExcelsiusGPS® (K171651) Other Predicates: ExcelsiusGPS® Spine 1.1 Interbody Module (K191100) Medtronic StealthStation S8 (K162309)… | 2017 |
| * | K191100 | ExcelsiusGPS Spine 1.1 Interbody ModuleSummary page 4…oduct Code(s): OLO, HAW Regulatory Class: II Primary Predicate: ExcelsiusGPS® (K171651) Other Predicates: ExcelsiusGPS® Spine 1.1 Interbody Module (K191100) Medtronic StealthStation S8 (K162309) ROSA ONE Brain (K182417) Purpose: The purpose of this… | 2019 |
| * | K162309 | StealthStation S8 System Platforms and StealthStation Cranial SoftwareSummary page 4…lass: II Primary Predicate: ExcelsiusGPS® (K171651) Other Predicates: ExcelsiusGPS® Spine 1.1 Interbody Module (K191100) Medtronic StealthStation S8 (K162309) ROSA ONE Brain (K182417) Purpose: The purpose of this submission is to request clearance of the ExcelsiusGPS®… | 2017 |
| * | K182417 | ROSA ONE Brain ApplicationSummary page 4…(K171651) Other Predicates: ExcelsiusGPS® Spine 1.1 Interbody Module (K191100) Medtronic StealthStation S8 (K162309) ROSA ONE Brain (K182417) Purpose: The purpose of this submission is to request clearance of the ExcelsiusGPS® Cranial 1.0 Module software and navigated… | 2019 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (7 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 11, 2023 | Class II | Z-0995-2024 | Package design/selection | Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip. |
| Dec 11, 2023 | Class II | Z-0996-2024 | Package design/selection | Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip. |
| Dec 11, 2023 | Class II | Z-0997-2024 | Package design/selection | Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip. |
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.
- K182417ROSA ONE Brain ApplicationMedtech S.A · 2019 · Direct predicate · ◆ in the 2019 ancestors bar of FIG. 11 Class I recall
- K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · Direct predicate · ◆ in the 2017 ancestors bar of FIG. 12 Class I recalls
- K172444ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · 2 generations back · ◆ in the 2018 ancestors bar of FIG. 11 Class I recall
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 2 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K151359ROSA BrainMedtech S.A · 2015 · 3 generations back · ◆ in the 2015 ancestors bar of FIG. 11 Class I recall
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 3 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 90 of the 690 ancestors have a recall of any class; 7 have a Class I recall.
- Of its descendants, K231850 (Globus Medical, Inc., 2024) has gone furthest, with 2 descendants of its own.
- 27 other devices also cite its predicate K171651.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
The ExcelsiusGPS is intended for use as an aid for precisely locating anatomical structures and for 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 and interbody spacers, and intracranial devices including biopsy needles, electrodes, and tubes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200047 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200047: ExcelsiusGPS Cranial 1.0 Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200047
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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