510(k) · Cleared
ClearedAvs Aria Neuromonitoring Probe and Avs Aria Probe Dilators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · GXZ Electrode, Needle
Cleared on Jul 28, 2011 as substantially equivalent to K090838 (Axon Systems, Inc., 2009) and 2 other predicates after a 164-day review. Its family tree reaches back 5 generations to 1998. 9 later devices descend from it.
- Decided
- Jul 28, 2011
- Review
- 164 days
- Class
- Class II
- Product code
- GXZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K980148 (1998). 12 ancestors in all, the oldest K850107 (1985). 9 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK980148 Neurosign 800, 8 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1998
- 4 generations backK992869 Xomed Ball-Tip Monopolar Stimulator ProbeXomed, Inc. · 1999
- 3 generations backK014165 Stimulus - Dissection InstrumentsMedtronic Xomed, Inc. · 2002
- 2 generations backK031003 Stimulus/Dissection Instruments, Ball-Tip ProbesMedtronic Xomed, Inc. · 2003 · Recalled
- 1 generation backK090838 Stimulus/Dissection InstrumentsAxon Systems, Inc. · 2009
- This deviceK110419 Avs Aria Neuromonitoring Probe and Avs Aria Probe DilatorsStryker Spine · 2011
- Descendant · cites it directly · 5 of its ownK132373 Biomet Access SystemBiomet Spine (Aka Ebi, LLC) · 2014
- Descendant · 2 generations on · 4 of its ownK142438 Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · 2015
- Descendant · 3 generations on · 3 of its ownK182617 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
- Descendant · 4 generations on · 2 of its ownK191723 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK140088 Phantom XL Insulated DilatorsTedan Surgical Innovations, LLC · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K132373Biomet Access SystemBiomet Spine (Aka Ebi, LLC) · 2014 · cites it directly5descendants
- K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · 2015 · 2 generations on4descendants
- K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019 · 3 generations on3descendants
- K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019 · 4 generations on2descendants
- K140088Phantom XL Insulated DilatorsTedan Surgical Innovations, LLC · 2014 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K980148 | Neurosign 800, 8 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1998 | — |
| −4 | K992869 | Xomed Ball-Tip Monopolar Stimulator Probe | Xomed, Inc. | 1999 | — |
| −3 | K014165 | Stimulus - Dissection Instruments | Medtronic Xomed, Inc. | 2002 | — |
| −2 | K031003 | Stimulus/Dissection Instruments, Ball-Tip Probes | Medtronic Xomed, Inc. | 2003 | 1 |
| −1 | K090838 | Stimulus/Dissection Instruments | Axon Systems, Inc. | 2009 | — |
| 0 (this device) | K110419 | Avs Aria Neuromonitoring Probe and Avs Aria Probe Dilators | Stryker Spine | 2011 | — |
| +1 | K132373 | Biomet Access System | Biomet Spine (Aka Ebi, LLC) | 2014 | — |
| +2 | K142438 | Nerve Monitoring Cable System | Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) | 2015 | — |
| +3 | K182617 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
| +4 | K191723 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
| +1 | K140088 | Phantom XL Insulated Dilators | Tedan Surgical Innovations, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 1 | 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.
Planning a device in GXZ? 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 GXZ device
- #1 K231691 Phantom XL Insulated Dilatorsscore 10.4 · 7 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 |
|---|---|---|---|
| * | K090838 | Stimulus/Dissection InstrumentsSummary page 2…s and have the same indications for use, design, function, and materials used. 510(k) Cornpany Name Device Name IK090838 IAxon Systems, Inc. I XPAK &XPAK 11 K062996 Axon Systems, Inc. Disposable Stimulator Probes… | 2009 |
| * | K062996 | Disposable Monopolar and Bipolar Stimulator ProbesSummary page 2…used. 510(k) Cornpany Name Device Name IK090838 IAxon Systems, Inc. I XPAK &XPAK 11 K062996 Axon Systems, Inc. Disposable Stimulator Probes K8501 07 Carefusion (Nicolet) Probes Pe… | 2007 |
| * | K850107 | Concentric Needle Electrodes-Various Sizes W/ConneSummary page 2…IK090838 IAxon Systems, Inc. I XPAK &XPAK 11 K062996 Axon Systems, Inc. Disposable Stimulator Probes K8501 07 Carefusion (Nicolet) Probes Performance Standards: The device was tested in accordance with IEC 60601-1-2: 2007 a… | 1985 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K132373 (Biomet Spine (Aka Ebi, LLC), 2014) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K090838.
How does its category compare?
All GXZ devicesGXZ Electrode, Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · GXZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GXZ
102in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXZ
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXZ
75in 2025
MAUDE reports naming product code GXZ, 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 | 102 | 0 | 2 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 19 | 4 |
| 2011 | 2 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 12 |
| 2013 | 2 | — | 0 | 6 |
| 2014 | 2 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 1 | — | 0 | 11 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 2 | — | 0 | 14 |
| 2020 | 1 | — | 0 | 7 |
| 2021 | 0 | — | 1 | 9 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 2 | — | 0 | 21 |
| 2024 | 1 | — | 0 | 58 |
| 2025 | 0 | — | 0 | 75 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AVS® ARIA Neuromonitoring Probe and AVS® ARIA Probe Dilators are indicated for use during surgery of the spine to deliver an electrical stimulus to the tissues and nerves at the operative site to assist in locating those nerves at risk during the surgical procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110419: Avs Aria Neuromonitoring Probe and Avs Aria Probe Dilators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110419
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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