510(k) · Cleared
ClearedExcelsiusGPS™ Instruments
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 Nov 5, 2025 as substantially equivalent to K191100 (Globus Medical, Inc., 2019) and 9 other predicates after a 250-day review. Its family tree reaches back 26 generations to 1984. 6 of the 945 devices in its family, counting itself, have a Class I recall.
- Decided
- Nov 5, 2025
- Review
- 250 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 26 generations to K841189 (1984). 944 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 6 of the 945 devices in this family, counting this one, have a Class I recall.
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations between
- 3 generations backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- 2 generations backK203278 INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT…Globus Medical, Inc. · 2021
- 1 generation backK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
- This deviceK250599 ExcelsiusGPS™ InstrumentsGlobus Medical, Inc. · 2025
Show all 26 generations
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 25 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 24 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 23 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 22 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 20 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 19 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 18 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 16 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 15 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 14 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 13 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 12 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 11 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 10 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 9 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 8 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 7 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 6 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 5 generations backK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
- 4 generations backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
- 3 generations backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- 2 generations backK203278 INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT…Globus Medical, Inc. · 2021
- 1 generation backK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
- This deviceK250599 ExcelsiusGPS™ InstrumentsGlobus Medical, Inc. · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −25 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −24 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −23 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −22 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −20 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −19 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −18 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −16 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −15 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −14 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −13 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −12 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −11 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −10 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −9 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −8 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −7 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −6 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −5 | K172341 | NuVasive® Modulus TLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −4 | K193593 | NuVasive 3DP Interfixated ALIF System | Nu Vasive, Incorporated | 2020 | — |
| −3 | K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System… | Nu Vasive, Incorporated | 2020 | — |
| −2 | K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers… | Globus Medical, Inc. | 2021 | — |
| −1 | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer… | Globus Medical, Inc. | 2022 | — |
| 0 (this device) | K250599 | ExcelsiusGPS™ Instruments | Globus Medical, Inc. | 2025 | — |
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 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 3 | 0 |
| 1988 | 2 | 0 |
| 1989 | 5 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 4 | 0 |
| 1994 | 7 | 0 |
| 1995 | 15 | 0 |
| 1996 | 18 | 0 |
| 1997 | 14 | 0 |
| 1998 | 21 | 0 |
| 1999 | 24 | 0 |
| 2000 | 30 | 0 |
| 2001 | 42 | 1 |
| 2002 | 35 | 0 |
| 2003 | 42 | 0 |
| 2004 | 68 | 0 |
| 2005 | 58 | 0 |
| 2006 | 39 | 0 |
| 2007 | 35 | 0 |
| 2008 | 75 | 1 |
| 2009 | 56 | 0 |
| 2010 | 44 | 1 |
| 2011 | 57 | 0 |
| 2012 | 36 | 0 |
| 2013 | 38 | 0 |
| 2014 | 36 | 0 |
| 2015 | 38 | 1 |
| 2016 | 21 | 1 |
| 2017 | 18 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 1 |
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.
6 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? (10)
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 |
|---|---|---|---|
| * | K191100 | ExcelsiusGPS Spine 1.1 Interbody ModuleSummary page 5…60 Stereotaxic instrument Product Code(s): OLO Regulatory Class: II Primary Predicate: ExcelsiusGPS™ Spine 1.1 Interbody Module (K191100) Additional Predicates: ExcelsiusHub™ (K211616) HEDRON™ & SABLE™ Spacers (K222270)… | 2019 |
| * | K211616 | ExcelsiusHubSummary page 5…de(s): OLO Regulatory Class: II Primary Predicate: ExcelsiusGPS™ Spine 1.1 Interbody Module (K191100) Additional Predicates: ExcelsiusHub™ (K211616) HEDRON™ & SABLE™ Spacers (K222270) NuVasive™ Modulus™ XLIF Interbody System (K201692,… | 2021 |
| * | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Summary page 5…imary Predicate: ExcelsiusGPS™ Spine 1.1 Interbody Module (K191100) Additional Predicates: ExcelsiusHub™ (K211616) HEDRON™ & SABLE™ Spacers (K222270) NuVasive™ Modulus™ XLIF Interbody System (K201692, K203714) NuVasive… | 2022 |
| * | K201692 | NuVasive Modulus XLIF Interbody SystemSummary page 5…ditional Predicates: ExcelsiusHub™ (K211616) HEDRON™ & SABLE™ Spacers (K222270) NuVasive™ Modulus™ XLIF Interbody System (K201692, K203714) NuVasive™ Cohere™ XLIF Thoracolumbar Interbody System (K200… | 2020 |
| * | K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Summary page 5…ExcelsiusHub™ (K211616) HEDRON™ & SABLE™ Spacers (K222270) NuVasive™ Modulus™ XLIF Interbody System (K201692, K203714) NuVasive™ Cohere™ XLIF Thoracolumbar Interbody System (K200953, K203714)… | 2021 |
| * | K200953 | NuVasive® Cohere® Thoracolumbar Interbody SystemSummary page 5…ive™ Modulus™ XLIF Interbody System (K201692, K203714) NuVasive™ Cohere™ XLIF Thoracolumbar Interbody System (K200953, K203714) NuVasive™ Modulus™ TLIF-O (K172341, K203714) NuVasive™ Cohere™ TLIF-O (K193541,… | 2020 |
| * | K172341 | NuVasive® Modulus TLIF Interbody SystemSummary page 5…K203714) NuVasive™ Cohere™ XLIF Thoracolumbar Interbody System (K200953, K203714) NuVasive™ Modulus™ TLIF-O (K172341, K203714) NuVasive™ Cohere™ TLIF-O (K193541, K203714) ELSA™ Spacers (K161379, K203278) Pu… | 2017 |
| * | K193541 | NuVasive Cohere Thoracolumbar Interbody SystemSummary page 5…ar Interbody System (K200953, K203714) NuVasive™ Modulus™ TLIF-O (K172341, K203714) NuVasive™ Cohere™ TLIF-O (K193541, K203714) ELSA™ Spacers (K161379, K203278) Purpose: The purpose of this submission is to request clearance of… | 2020 |
| * | K161379 | ELSA SpacersSummary page 5…3714) NuVasive™ Modulus™ TLIF-O (K172341, K203714) NuVasive™ Cohere™ TLIF-O (K193541, K203714) ELSA™ Spacers (K161379, K203278) Purpose: The purpose of this submission is to request clearance of additional ExcelsiusGPS™ instruments for use with ad… | 2016 |
| * | K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Summary page 5…NuVasive™ Modulus™ TLIF-O (K172341, K203714) NuVasive™ Cohere™ TLIF-O (K193541, K203714) ELSA™ Spacers (K161379, K203278) Purpose: The purpose of this submission is to request clearance of additional ExcelsiusGPS™ instruments for use with additional… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (6 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 · Direct predicate · ◆ in the 2021 ancestors bar of FIG. 11 Class I recall
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 3 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 4 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 5 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 6 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 41 years and passes through 13 companies; a new generation was cleared every 10 months on median.
- 121 of the 944 ancestors have a recall of any class; 6 have a Class I recall.
- 10 other devices also cite its predicate K191100.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
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…
Read the full statement (142 words)
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 and interbody fusion devices.
ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating 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 fusion devices.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250599 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250599: ExcelsiusGPS™ Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250599
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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