# K002677: Nuvasive Ins-1 Intraoperative Nerve Surveillance System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Nov 13, 2000 after 77 days
- Product code: BXM (Stimulator, Nerve, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 868.2775
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
31 later devices descend from it; 5 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Brackmann II™ EMG Monitoring System: named in the summary without a submission number
- (no number) Neurovision SE Nerve Locator/Monitor: named in the summary without a submission number
- (no number) Viking IV™ Electromyography System: named in the summary without a submission number
- (no number) Epoch 2000 Neurological Workstation: named in the summary without a submission number
- (no number) Neurosign 400 Motor Nerve Monitor: named in the summary without a submission number

## Most influential descendants
- K090838: Stimulus/Dissection Instruments (2009), 19 descendants of its own
- K111597: Disposable Stimulating Electrode (2011), 10 descendants of its own
- K112709: Stimulation/Dissection Instruments (2012), 9 descendants of its own
- K110419: Avs Aria Neuromonitoring Probe and Avs Aria Probe Dilators (2011), 9 descendants of its own
- K030526: Pediguard Nerve Detector System (2004), 6 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K002677
Methodology: https://510kreport.com/methodology