510(k) · Cleared
ClearedOrthomon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axon Systems, Inc. · GWF Stimulator, Electrical, Evoked Response
Cleared on May 23, 2006 as substantially equivalent to K050798 (Axon Systems, Inc., 2005) and 2 other predicates after a 32-day review. Its family tree reaches back 5 generations to 1984. 1 of the 466 devices in its family, counting itself, has a Class I recall. 450 later devices descend from it.
- Decided
- May 23, 2006
- Review
- 32 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K842956 (1984). 15 ancestors in all. 450 later devices descend from it, 4 citing it directly. 1 of the 466 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 4 generations backK971819 Epoch 2000 Neurological WorkstationAxon Systems, Inc. · 1997
- 3 generations backK022785 Epoch XP Neurological Workstation; Epoch XP Lite Neurological…Axon Systems, Inc. · 2002
- 2 generations backK032741 Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003
- 1 generation backK050798 Eclipse Neurological WorkstationAxon Systems, Inc. · 2005
- This deviceK061113 OrthomonAxon Systems, Inc. · 2006
- Descendant · cites it directly · 418 of its ownK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 404 of its ownK124004 Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy…Medtronic Navigation, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 398 of its ownK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013
- Descendant · 2 generations on · 396 of its ownK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 246 of its ownK131425 Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale…Medtronic Navigation, Inc. · 2013 · Recalled
Showing 5 of 450 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 450 · See all- K111520Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · cites it directly418descendants
- K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc. · 2013 · 2 generations on404descendants
- K123270Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013 · 2 generations on398descendants
- K140454Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · 2 generations on396descendants
- K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc. · 2013 · 3 generations on246descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K842956 | Nicolet Viking | Nicolet Biomedical Instruments | 1984 | — |
| −4 | K971819 | Epoch 2000 Neurological Workstation | Axon Systems, Inc. | 1997 | — |
| −3 | K022785 | Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation | Axon Systems, Inc. | 2002 | — |
| −2 | K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation | Axon Systems, Inc. | 2003 | — |
| −1 | K050798 | Eclipse Neurological Workstation | Axon Systems, Inc. | 2005 | — |
| 0 (this device) | K061113 | Orthomon | Axon Systems, Inc. | 2006 | — |
| +1 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| +2 | K124004 | Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps | Medtronic Navigation, Inc. | 2013 | 1 |
| +2 | K123270 | Powerease System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| +2 | K140454 | Navigated CD Horizon Solera Screwdriver/Taps | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
| +3 | K131425 | Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter | Medtronic Navigation, Inc. | 2013 | 10 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 8 | 0 |
| 2016 | 8 | 0 |
| 2017 | 17 | 0 |
| 2018 | 19 | 0 |
| 2019 | 30 | 0 |
| 2020 | 22 | 0 |
| 2021 | 42 | 1 |
| 2022 | 47 | 0 |
| 2023 | 64 | 0 |
| 2024 | 61 | 0 |
| 2025 | 63 | 0 |
| 2026 | 56 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GWF device
- #1 K263010 ISIS Headboxes, ISIS Neurostimulator, ISIS…score 17.5 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050798 | Eclipse Neurological WorkstationSummary page 1…ograph, Evoked Response Stimulator Product Codes: GWF, lKN Predicate Devices Axon Systems: Eclipse Neurological Workstation (K050798) NuVasive: Neurovision JJB (K051384) Datex-Ohmeda: M-NMT Neuromuscular Transmission… | 2005 |
| * | K051384 | Modification to: Nuvasive Neurovision JJB SystemSummary page 1…ulator Product Codes: GWF, lKN Predicate Devices Axon Systems: Eclipse Neurological Workstation (K050798) NuVasive: Neurovision JJB (K051384) Datex-Ohmeda: M-NMT Neuromuscular Transmission Module (K955026)… | 2005 |
| * | K955026 | AS/3 NMT ModuleSummary page 1…NuVasive: Neurovision JJB (K051384) Datex-Ohmeda: M-NMT Neuromuscular Transmission Module (K955026) 00Oser Awenue, ldauppauge, NY 11 788 631,41366112 Fax: 631t436,5i41 AXnu1 Syt-tems… | 1997 |
What descends from it? (450)
See all 4504 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K111520 (Medtronic Xomed, Inc., 2011) has gone furthest, with 418 descendants of its own.
- 2 other devices also cite its predicate K050798.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWF
92in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWF
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWF
1,034in 2025
MAUDE reports naming product code GWF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 69 | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 5 | 178 | 0 | 1 |
| 2010 | 3 | 269 | 0 | 4 |
| 2011 | 2 | — | 0 | 10 |
| 2012 | 4 | 230 | 1 | 44 |
| 2013 | 3 | 174 | 0 | 89 |
| 2014 | 1 | — | 0 | 25 |
| 2015 | 2 | — | 1 | 22 |
| 2016 | 1 | — | 0 | 20 |
| 2017 | 3 | 169 | 0 | 60 |
| 2018 | 0 | — | 0 | 58 |
| 2019 | 1 | — | 0 | 94 |
| 2020 | 1 | — | 0 | 65 |
| 2021 | 2 | — | 0 | 55 |
| 2022 | 2 | — | 0 | 45 |
| 2023 | 2 | — | 0 | 150 |
| 2024 | 4 | 92 | 0 | 854 |
| 2025 | 1 | — | 0 | 1,034 |
| 2026 | 3 | 125 | 2 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061113: Orthomon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061113
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026