510(k) · Cleared
Recalled · Class III · 2022NuVasive Pulse System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · OLO Orthopedic Stereotaxic Instrument
Cleared on Jul 29, 2021 as substantially equivalent to K180038 (Nu Vasive, Incorporated, 2018) and 2 other predicates after a 153-day review. Its family tree reaches back 20 generations to 2001. 2 of the 366 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled once.
- Decided
- Jul 29, 2021
- Review
- 153 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 20 generations to K003155 (2001). 363 ancestors in all, the oldest K792352 (1979). 2 later devices descend from it, 2 citing it directly. 2 of the 366 devices in this family, counting this one, have a Class I recall.
- Root · 20 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 16 generations between
- 3 generations backK191039 Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc. · 2019
- 2 generations backK192336 Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2019
- 1 generation backK200719 NuVasive Navigation.S InstrumentsNu Vasive, Incorporated · 2020
- This deviceK210574 NuVasive Pulse SystemNu Vasive, Incorporated · 2021
- Descendant · cites it directly · 0 of its ownK243814 NuVasive Pulse SystemGlobus Medical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK230989 Rod Registration FrameNu Vasive, Incorporated · 2023
Show all 20 generations
- Root · 20 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 19 generations backK012254 VBROsteotech, Inc. · 2001
- 18 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 17 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 16 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 15 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 11 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 10 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 9 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 8 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 7 generations backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- 6 generations backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
- 5 generations backK142559 ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 4 generations backK163581 Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2017
- 3 generations backK191039 Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc. · 2019
- 2 generations backK192336 Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2019
- 1 generation backK200719 NuVasive Navigation.S InstrumentsNu Vasive, Incorporated · 2020
- This deviceK210574 NuVasive Pulse SystemNu Vasive, Incorporated · 2021
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −19 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −18 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −17 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −16 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −15 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −12 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −11 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −10 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −9 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −8 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −7 | K111264 | Cornerstone (R) PSR Cervical Fusion System | Medtronic Sofamor Danek USA | 2011 | — |
| −6 | K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System… | Medtronic Sofamor Danek, Inc. | 2013 | — |
| −5 | K142559 | ELEVATE Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −4 | K163581 | Navigated ELEVATE Inserter, Navigated Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
| −3 | K191039 | Navigated T2 STRATOSPHERE Inserters and Navigated Templates | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| −2 | K192336 | Navigated Anterolateral Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| −1 | K200719 | NuVasive Navigation.S Instruments | Nu Vasive, Incorporated | 2020 | — |
| 0 (this device) | K210574 | NuVasive Pulse System | Nu Vasive, Incorporated | 2021 | — |
| +1 | K243814 | NuVasive Pulse System | Globus Medical, Inc. | 2025 | — |
| +1 | K230989 | Rod Registration Frame | Nu Vasive, Incorporated | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 4 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 6 | 0 |
| 1993 | 2 | 0 |
| 1994 | 9 | 0 |
| 1995 | 10 | 0 |
| 1996 | 7 | 0 |
| 1997 | 7 | 0 |
| 1998 | 9 | 0 |
| 1999 | 12 | 0 |
| 2000 | 11 | 0 |
| 2001 | 16 | 0 |
| 2002 | 18 | 0 |
| 2003 | 22 | 0 |
| 2004 | 39 | 0 |
| 2005 | 25 | 0 |
| 2006 | 13 | 0 |
| 2007 | 14 | 0 |
| 2008 | 23 | 0 |
| 2009 | 16 | 0 |
| 2010 | 10 | 0 |
| 2011 | 14 | 0 |
| 2012 | 11 | 0 |
| 2013 | 7 | 0 |
| 2014 | 6 | 0 |
| 2015 | 5 | 1 |
| 2016 | 4 | 1 |
| 2017 | 6 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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.
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 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 |
|---|---|---|---|
| * | K180038 | NuVasive Pulse SystemSummary page 5…, HAW, IKN, OWB, LLZ, JAA C. Predicate Devices The subject NuVasive Pulse System is substantially equivalent to the primary predicate NuVasive Pulse System (K180038). It is also substantially equivalent to the additional predicate devices StealthStation S8 Spine Software V1.0.0 (K170011),… | 2018 |
| * | K170011 | StealthStation S8 Spine Software v1.0.0Summary page 5…ary predicate NuVasive Pulse System (K180038). It is also substantially equivalent to the additional predicate devices StealthStation S8 Spine Software V1.0.0 (K170011), and NuVasive Navigation.S Instruments (K200719). D. Device Description The Pulse System is a medical device consis… | 2017 |
| * | K200719 | NuVasive Navigation.S InstrumentsSummary page 5…is also substantially equivalent to the additional predicate devices StealthStation S8 Spine Software V1.0.0 (K170011), and NuVasive Navigation.S Instruments (K200719). D. Device Description The Pulse System is a medical device consisting of Pulse NVM5, Pulse LessRay, and Pulse Navi… | 2020 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 19, 2022 | Class III | Z-1052-2023 | Software design | Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures. |
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.
What does this lineage say?
- The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
- 41 of the 363 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K243814 (Globus Medical, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Pulse System is a medical device comprised of Pulse NVM5, Pulse LessRay, and Pulse Navigation. Pulse NVM5 is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. The device provides information directly to the surgeon, to help assess a patient’s neurophysiologic status. The Pulse NVM5 provides this information by electrically stimulating nerves via…
Read the full statement (507 words)
The Pulse System is a medical device comprised of Pulse NVM5, Pulse LessRay, and Pulse Navigation.
Pulse NVM5 is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. The device provides information directly to the surgeon, to help assess a patient’s neurophysiologic status. The Pulse NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods.
• XLIF (Detection) – The XLIF (Detection) function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool.
• Basic & Dynamic Screw Test – The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws.
• Free Run EMG – The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.
• Twitch Test (Train of Four) – The Twitch Test Function allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.
• MEP – Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury.
• SSEP – The SSEP function allows the surgeon to assess sensory spinal cord function in surgical procedures during which the spinal cord is at risk.
• Remote Access - The remote monitoring and local wireless control provides real-time capabilities to the Pulse System
• Bendini – The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.
Pulse LessRay is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.
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/K210574 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210574: 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/K210574
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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