# K013215: Modified Ins-1 Intraoperative Nerve Surveillance System

- Pathway: 510(k) (Special)
- Applicant: Nuvasive, Inc.
- Decided: Oct 16, 2001 after 20 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
Longest line of descent: 1 generation back to K002677 (2000). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002677: Nuvasive Ins-1 Intraoperative Nerve Surveillance System, Nuvasive, Inc. (2000) Summary page 1.

## Most influential descendants
- K073229: Nerve Monitoring Cable (2008), 5 descendants of its own
- K142438: Nerve Monitoring Cable System (2015), 4 descendants of its own
- K182617: ATEC IOM Accessory Instruments (2019), 3 descendants of its own
- K191723: ATEC IOM Accessory Instruments (2019), 2 descendants of its own
- K221821: ATEC IOM Accessory Instruments (2022), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K013215
Methodology: https://510kreport.com/methodology