# K992869: Xomed Ball-Tip Monopolar Stimulator Probe

- Pathway: 510(k) (Traditional)
- Applicant: Xomed, Inc.
- Decided: Oct 7, 1999 after 43 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: 1 generation back to K980148 (1998). 1 ancestor in all.
484 later devices descend from it; 7 cite it directly.
2 of 486 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980148: Neurosign 800, 8 Channel Motor Nerve Monitor, The Magstim Company, Ltd. (1998) Summary page 1.

## Most influential descendants
- K063305: Stimulating Bur Guard (2006), 424 descendants of its own
- K111520: Ipc Powerease System (2011), 418 descendants of its own
- K124004: Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps (2013), 404 descendants of its own
- K123270: Powerease System (2013), 398 descendants of its own
- K140454: Navigated CD Horizon Solera Screwdriver/Taps (2014), 396 descendants of its own

## Indications for use
The Ball-Tip Monopolar Stimulating Probe is intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

Source page: https://510kreport.com/device/K992869
Methodology: https://510kreport.com/methodology