# K152505: C2 NerveMonitor System

- Pathway: 510(k) (Traditional)
- Applicant: Inomed Medizintechnik GmbH
- Decided: Feb 1, 2016 after 152 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K980148 (1998). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111647: C2 Nervemonitor System with Accessories, Inomed Medizintechnik GmbH (2011) Summary page 4.

## Most influential descendants
- K223254: C2 Xplore (2023), 0 descendants of its own

## Recalls of this device
- Jul 31, 2019 · Class II · Z-0023-2020: Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the functionality of the device, which may result in use errors potentially causing or contribut
- Jul 31, 2019 · Class II · Z-0024-2020: Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the functionality of the device, which may result in use errors potentially causing or contribut

## Indications for use
The C2 NerveMonitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery, including spinal nerve roots. The C2 NerveMonitor device with the integrated user interface is only allowed for the surveillance, documentation and functional test of motor nerves. It can be used as an additional helping tool during surgical procedures for diagnostic issues. Its basic functions are similar to those of an EMG diagnostic device. Indications for C2 NerveMonitor System Monitoring Procedures include: Extracranial, Intratemporal, Extratemporal, Neck Dissections, and Upper and Lower Extremities. Indications for C2 NerveMonitor System monitoring of Spinal procedures include: Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Orthopedic Surgery, Open and Percutaneous Lumbar and Cervical Surgical Procedures. The system is not intended for monitoring life preserving functions. The system may not be used for diagnosing brain death.

Source page: https://510kreport.com/device/K152505
Methodology: https://510kreport.com/methodology