# K083124: NIM 3.0

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed, Inc.
- Decided: Feb 27, 2009 after 128 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K980148 (1998). 15 ancestors in all.
30 later devices descend from it; 6 cite it directly.
1 of 46 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031510: Nim-Spine, Medtronic Xomed (2003) Summary page 1.
- K024316: Nim-PRS, Medtronic Xomed, Inc. (2003) Summary page 1.

## Most influential descendants
- K182542: The EPAD 2 System (2019), 9 descendants of its own
- K162313: NuVasive Next Generation NVM5 System (2017), 7 descendants of its own
- K162199: Cascade IOMAX Intraoperative Monitor (2017), 7 descendants of its own
- K212166: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2022), 5 descendants of its own
- K213849: SafeOp 2: Neural Informatix System (2022), 4 descendants of its own

## Recalls of this device
- Sep 27, 2010 · Class II · Z-2342-2012: In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 dete
- Sep 27, 2010 · Class II · Z-2344-2012: In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 dete
- Sep 27, 2010 · Class II · Z-2343-2012: In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 dete

## Indications for use
The NIM 3.0 is intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots. The APS electrode is an accessory intended for providing afitomatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems. Indications for NIM 3.0 EMG Monitoring Procedures include: Intracranial, Extracranial, Intratemporal, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities Indications for Spinal procedures which may use NIM 3.0 EMG monitoring include: Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery, Open and Percutaneous Lumbar and Cervical Surgical Procedures, and Thoracic Surgical Procedures.

Source page: https://510kreport.com/device/K083124
Methodology: https://510kreport.com/methodology