# K103128: Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw Stimulator Probe,

- Pathway: 510(k) (Traditional)
- Applicant: Cadwell Lab, Inc.
- Decided: Feb 23, 2011 after 121 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K923056 (1992). 11 ancestors in all.
17 later devices descend from it; 5 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050325: Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar Probe, Technomed Europe (2005) Summary page 1.
- K063729: Disposable Pedicle Screw Probe, Model 3603-00, Technomed Europe (2007) Summary page 1.
- K062996: Disposable Monopolar and Bipolar Stimulator Probes, Axon Systems, Inc. (2007) Summary page 1.
- K992869: Xomed Ball-Tip Monopolar Stimulator Probe, Xomed, Inc. (1999) Summary page 1.
- K062549: Xltek Stimulator Probes, Models 105233, 105234, 105235, 105236, 105237 and 105238, Excel Tech., Ltd. (2006) Summary page 1.
- K031003: Stimulus/Dissection Instruments, Ball-Tip Probes, Medtronic Xomed, Inc. (2003) Summary page 1.
- K014165: Stimulus - Dissection Instruments, Medtronic Xomed, Inc. (2002) Summary page 1.

## Most influential descendants
- K111597: Disposable Stimulating Electrode (2011), 10 descendants of its own
- K112709: Stimulation/Dissection Instruments (2012), 9 descendants of its own
- K132373: Biomet Access System (2014), 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

## Indications for use
Cadwell Disposable Stimulator Probe is used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery. The Cadwell Disposable Stimulator Probe is a single patient use device.

Source page: https://510kreport.com/device/K103128
Methodology: https://510kreport.com/methodology