510(k) · Cleared
ClearedNuvasive Ins-1 Intraoperative Nerve Surveillance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · BXM Stimulator, Nerve, Ac-Powered
Cleared on Nov 13, 2000 after a 77-day review. The FDA summary names its predicate without a number. 31 later devices descend from it.
- Decided
- Nov 13, 2000
- Review
- 77 days
- Class
- Class II
- Product code
- BXM
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 5 citing it directly.
- This deviceK002677 Nuvasive Ins-1 Intraoperative Nerve Surveillance SystemNuvasive, Inc. · 2000
- Descendant · cites it directly · 19 of its ownK090838 Stimulus/Dissection InstrumentsAxon Systems, Inc. · 2009
- Descendant · 2 generations on · 10 of its ownK111597 Disposable Stimulating ElectrodeNuvasive, Inc. · 2011
- Descendant · 3 generations on · 9 of its ownK112709 Stimulation/Dissection InstrumentsNu Vasive, Incorporated · 2012
- Descendant · 2 generations on · 9 of its ownK110419 Avs Aria Neuromonitoring Probe and Avs Aria Probe DilatorsStryker Spine · 2011
- Descendant · cites it directly · 6 of its ownK030526 Pediguard Nerve Detector SystemSpine Vision, Inc. · 2004
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K090838Stimulus/Dissection InstrumentsAxon Systems, Inc. · 2009 · cites it directly19descendants
- K111597Disposable Stimulating ElectrodeNuvasive, Inc. · 2011 · 2 generations on10descendants
- K112709Stimulation/Dissection InstrumentsNu Vasive, Incorporated · 2012 · 3 generations on9descendants
- K110419Avs Aria Neuromonitoring Probe and Avs Aria Probe DilatorsStryker Spine · 2011 · 2 generations on9descendants
- K030526Pediguard Nerve Detector SystemSpine Vision, Inc. · 2004 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002677 | Nuvasive Ins-1 Intraoperative Nerve Surveillance System | Nuvasive, Inc. | 2000 | — |
| +1 | K090838 | Stimulus/Dissection Instruments | Axon Systems, Inc. | 2009 | — |
| +2 | K111597 | Disposable Stimulating Electrode | Nuvasive, Inc. | 2011 | — |
| +3 | K112709 | Stimulation/Dissection Instruments | Nu Vasive, Incorporated | 2012 | — |
| +2 | K110419 | Avs Aria Neuromonitoring Probe and Avs Aria Probe Dilators | Stryker Spine | 2011 | — |
| +1 | K030526 | Pediguard Nerve Detector System | Spine Vision, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2026 | 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.
Planning a device in BXM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | — | Brackmann II™ EMG Monitoring System Named without a submission number | |
| * | — | Neurovision SE Nerve Locator/Monitor Named without a submission number | |
| * | — | Viking IV™ Electromyography System Named without a submission number | |
| * | — | Epoch 2000 Neurological Workstation Named without a submission number | |
| * | — | Neurosign 400 Motor Nerve Monitor Named without a submission number |
What descends from it? (31)
See all 315 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K090838 (Axon Systems, Inc., 2009) has gone furthest, with 19 descendants of its own.
How does its category compare?
All BXM devicesBXM Stimulator, Nerve, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BXM
FDA has decided no BXM device since 2007.
Median 510(k) review, days · BXM
Too few BXM 510(k)s in any year since 2007 to give a median.
Recalls per year · BXM
No recall names BXM since 2007.
Adverse event reports per year · BXM
1in 2012
MAUDE reports naming product code BXM, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The INS-1 Intraoperative Nerve Surveillance System is intended to provide intraoperative electromyographic (EMG) surveillance to assist in the location and evaluation of spinal nerves during percutaneous surgery of the spine, by administration of low amperage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. The INS-1 System is designed for use in conjunction with the NuVasive…
Read the full statement (105 words)
The INS-1 Intraoperative Nerve Surveillance System is intended to provide intraoperative electromyographic (EMG) surveillance to assist in the location and evaluation of spinal nerves during percutaneous surgery of the spine, by administration of low amperage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. The INS-1 System is designed for use in conjunction with the NuVasive Guided Spinal Arthroscopy System to assist in gaining controlled percutaneous access to the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior or posterolateral approach, where anatomical restrictions safely permit.
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/K002677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002677: Nuvasive Ins-1 Intraoperative Nerve Surveillance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002677
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026