# K061113: Orthomon

- Pathway: 510(k) (Traditional)
- Applicant: Axon Systems, Inc.
- Decided: May 23, 2006 after 32 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- 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 K842956 (1984). 15 ancestors in all.
450 later devices descend from it; 4 cite it directly.
1 of 466 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050798: Eclipse Neurological Workstation, Axon Systems, Inc. (2005) Summary page 1.
- K051384: Modification to:  Nuvasive Neurovision JJB System, Nuvasive, Inc. (2005) Summary page 1.
- K955026: AS/3 NMT Module, Datex Medical Instrumentation, Inc. (1997) 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
The OrthMon system is intended for use to record, monitor and stimulate/record biopotential signals including electromyograph (EMG), evoked response and nerve/muscle potentials and for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction. The system provides feedback to the surgeon and OR team to assist in the localization and assessment of spinal nerves and verification of placement of spinal instrumentation to avoid injury to at risk nerve roots.

Source page: https://510kreport.com/device/K061113
Methodology: https://510kreport.com/methodology