510(k) · Cleared
ClearedNuVasive Pulse System
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 Jan 10, 2025 as substantially equivalent to K210574 (Nu Vasive, Incorporated, 2021) and 2 other predicates after a 30-day review. Its family tree reaches back 21 generations to 2001. 3 of the 763 devices in its family, counting itself, have a Class I recall.
- Decided
- Jan 10, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 21 generations to K003155 (2001). 762 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 3 of the 763 devices in this family, counting this one, have a Class I recall.
- Root · 21 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 17 generations between
- 3 generations backK192336 Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2019
- 2 generations backK200719 NuVasive Navigation.S InstrumentsNu Vasive, Incorporated · 2020
- 1 generation backK210574 NuVasive Pulse SystemNu Vasive, Incorporated · 2021 · Recalled
- This deviceK243814 NuVasive Pulse SystemGlobus Medical, Inc. · 2025
Show all 21 generations
- Root · 21 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 20 generations backK012254 VBROsteotech, Inc. · 2001
- 19 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 18 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 17 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 16 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 12 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 11 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 10 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 9 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 8 generations backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- 7 generations backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
- 6 generations backK142559 ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 5 generations backK163581 Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2017
- 4 generations backK191039 Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc. · 2019
- 3 generations backK192336 Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2019
- 2 generations backK200719 NuVasive Navigation.S InstrumentsNu Vasive, Incorporated · 2020
- 1 generation backK210574 NuVasive Pulse SystemNu Vasive, Incorporated · 2021 · Recalled
- This deviceK243814 NuVasive Pulse SystemGlobus 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 |
|---|---|---|---|---|---|
| −21 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −20 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −19 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −18 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −17 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −16 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −12 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −11 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −10 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −9 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −8 | K111264 | Cornerstone (R) PSR Cervical Fusion System | Medtronic Sofamor Danek USA | 2011 | — |
| −7 | K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System… | Medtronic Sofamor Danek, Inc. | 2013 | — |
| −6 | K142559 | ELEVATE Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −5 | K163581 | Navigated ELEVATE Inserter, Navigated Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
| −4 | K191039 | Navigated T2 STRATOSPHERE Inserters and Navigated Templates | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| −3 | K192336 | Navigated Anterolateral Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| −2 | K200719 | NuVasive Navigation.S Instruments | Nu Vasive, Incorporated | 2020 | — |
| −1 | K210574 | NuVasive Pulse System | Nu Vasive, Incorporated | 2021 | 1 |
| 0 (this device) | K243814 | NuVasive Pulse System | 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 | 2 | 0 |
| 1985 | 3 | 0 |
| 1986 | 2 | 0 |
| 1987 | 4 | 0 |
| 1988 | 4 | 0 |
| 1989 | 6 | 0 |
| 1990 | 4 | 0 |
| 1991 | 2 | 0 |
| 1992 | 7 | 0 |
| 1993 | 6 | 0 |
| 1994 | 12 | 0 |
| 1995 | 18 | 0 |
| 1996 | 20 | 0 |
| 1997 | 14 | 0 |
| 1998 | 20 | 0 |
| 1999 | 25 | 0 |
| 2000 | 26 | 0 |
| 2001 | 39 | 0 |
| 2002 | 35 | 0 |
| 2003 | 41 | 0 |
| 2004 | 64 | 0 |
| 2005 | 54 | 0 |
| 2006 | 34 | 0 |
| 2007 | 31 | 0 |
| 2008 | 62 | 0 |
| 2009 | 40 | 0 |
| 2010 | 34 | 1 |
| 2011 | 35 | 0 |
| 2012 | 20 | 0 |
| 2013 | 22 | 0 |
| 2014 | 17 | 0 |
| 2015 | 15 | 1 |
| 2016 | 7 | 1 |
| 2017 | 8 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 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.
3 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K210574 | NuVasive Pulse SystemSummary page 5…Product Code: OLO Subsequent Product Codes: PDQ, ETN, GWF, HAW, IKN, OWB, LLZ, JAA C. Predicate Devices Primary Predicate: NuVasive Pulse System (K210574) Other Predicates: ExcelsiusGPS (K171651 and K191100) D. Device Description The subject device, Pulse ICT Adapter… | 2021 |
| * | K171651 | Excelsius GPSSummary page 5…odes: PDQ, ETN, GWF, HAW, IKN, OWB, LLZ, JAA C. Predicate Devices Primary Predicate: NuVasive Pulse System (K210574) Other Predicates: ExcelsiusGPS (K171651 and K191100) D. Device Description The subject device, Pulse ICT Adapter is introducing compatibility based on the desi… | 2017 |
| * | K191100 | ExcelsiusGPS Spine 1.1 Interbody ModuleSummary page 5…DQ, ETN, GWF, HAW, IKN, OWB, LLZ, JAA C. Predicate Devices Primary Predicate: NuVasive Pulse System (K210574) Other Predicates: ExcelsiusGPS (K171651 and K191100) D. Device Description The subject device, Pulse ICT Adapter is introducing compatibility based on the design of existi… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- 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 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 93 of the 762 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K210574.
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?
Pulse Navigation is intended as an intraoperative image-guided localization system in either open or minimally invasive spinal surgical procedures. Instruments and implants tracked by a passive marker sensor system are virtually displayed on a patient's 3D radiographic image data. The system enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the acquired image of the anatomy.
This may include the following spinal implant procedures:
- Pedicle Screw Placement (cervical, thoracic, lumbar)
- Iliosacral screw placement
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243814: NuVasive Pulse System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243814
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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