510(k) · Cleared
ClearedModified 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 Oct 16, 2001 as substantially equivalent to K002677 (Nuvasive, Inc., 2000) after a 20-day review. Its family tree reaches back 1 generation to 2000. 6 later devices descend from it.
- Decided
- Oct 16, 2001
- Review
- 20 days
- Class
- Class II
- Product code
- BXM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002677 (2000). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002677 Nuvasive Ins-1 Intraoperative Nerve Surveillance SystemNuvasive, Inc. · 2000
- This deviceK013215 Modified Ins-1 Intraoperative Nerve Surveillance SystemNuvasive, Inc. · 2001
- Descendant · cites it directly · 5 of its ownK073229 Nerve Monitoring CablePioneer Surgical Technology · 2008
- Descendant · 2 generations on · 4 of its ownK142438 Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · 2015
- Descendant · 3 generations on · 3 of its ownK182617 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
- Descendant · 4 generations on · 2 of its ownK191723 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
- Descendant · 5 generations on · 1 of its ownK221821 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K073229Nerve Monitoring CablePioneer Surgical Technology · 2008 · cites it directly5descendants
- K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · 2015 · 2 generations on4descendants
- K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019 · 3 generations on3descendants
- K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019 · 4 generations on2descendants
- K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002677 | Nuvasive Ins-1 Intraoperative Nerve Surveillance System | Nuvasive, Inc. | 2000 | — |
| 0 (this device) | K013215 | Modified Ins-1 Intraoperative Nerve Surveillance System | Nuvasive, Inc. | 2001 | — |
| +1 | K073229 | Nerve Monitoring Cable | Pioneer Surgical Technology | 2008 | — |
| +2 | K142438 | Nerve Monitoring Cable System | Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) | 2015 | — |
| +3 | K182617 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
| +4 | K191723 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
| +5 | K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (1)
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 |
|---|---|---|---|
| * | K002677 | Nuvasive Ins-1 Intraoperative Nerve Surveillance SystemSummary page 1…ctromyography (EMG) monitor/stimulator Classification: 868.2775 Product Code: BXM Classification name: Nerve Stimulator, AC-Powered Substantial equivalence claimed to: K002677: NuVasive INS-1 Intraoperative Nerve Surveillance System Description: The NeuroVision JJB System (NV JJB) is an electronic devi… | 2000 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073229 | Nerve Monitoring Cable | 2008 | 5 |
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?
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 NeuroVision JJB System is intended to provide intraoperative electromyographic (EMGQG) surveillance to assist in the location of nerves during percutaneous surgery of the spine, by administration of brief electrical stimulus pulses to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. The NeuroVision JJB Systcm is designed for use in conjunction with the NuVasive guided spinal arthroscopy…
Read the full statement (101 words)
The NeuroVision JJB System is intended to provide intraoperative electromyographic (EMGQG) surveillance to assist in the location of nerves during percutaneous surgery of the spine, by administration of brief electrical stimulus pulses to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. The NeuroVision JJB Systcm 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/K013215 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013215: Modified Ins-1 Intraoperative Nerve Surveillance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013215
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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