# K063305: Stimulating Bur Guard

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed, Inc.
- Decided: Nov 29, 2006 after 28 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: 2 generations back to K980148 (1998). 2 ancestors in all.
424 later devices descend from it; 2 cite it directly.
1 of 427 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992869: Xomed Ball-Tip Monopolar Stimulator Probe, Xomed, Inc. (1999) Summary page 1.

## Most influential descendants
- 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
- K131425: Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter (2013), 246 descendants of its own

## Indications for use
When used with both the Medtronic Nerve Integrity Monitor (NIM) and XPS Drill Systems, the Stimulating Bur Guard is intended to stimulate cranial and peripheral motor nerves, including spinal nerve roots, with a standard bur / blade for location and identification during the incision and removal of soft and hard tissue or bone. The Stimulating Bur Guard is indicated for nerve monitoring during the incision and removal of soft and hard tissue or bone with a standard bur / blade during otology, neurotology, sinus, laryngeal, nasopharyngeal, head and neck, general and plastic, and orthopedic surgical procedures, including spinal applications.

Source page: https://510kreport.com/device/K063305
Methodology: https://510kreport.com/methodology