510(k) · Cleared
ClearedNerve Monitoring Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology · GXZ Electrode, Needle
Cleared on Jun 6, 2008 as substantially equivalent to K063729 (Technomed Europe, 2007) and 5 other predicates after a 204-day review. Its family tree reaches back 5 generations to 1992. 5 later devices descend from it.
- Decided
- Jun 6, 2008
- Review
- 204 days
- Class
- Class II
- Product code
- GXZ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K923056 (1992). 32 ancestors in all, the oldest K850107 (1985). 5 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK923056 Neurosign Model 100The Magstim Company, Ltd. · 1992 · Recalled
- 4 generations backK991583 Neurosign 400, 4 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1999
- 3 generations backK050325 Disposable Concentric Probe, Disposable Bipolar Probe, Disposable…Technomed Europe · 2005
- 2 generations backK062996 Disposable Monopolar and Bipolar Stimulator ProbesAxon Systems, Inc. · 2007
- 1 generation backK063729 Disposable Pedicle Screw Probe, Model 3603-00Technomed Europe · 2007
- This deviceK073229 Nerve Monitoring CablePioneer Surgical Technology · 2008
- Descendant · cites it directly · 4 of its ownK142438 Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · 2015
- Descendant · 2 generations on · 3 of its ownK182617 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
- Descendant · 3 generations on · 2 of its ownK191723 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
- Descendant · 4 generations on · 1 of its ownK221821 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022
- Descendant · 5 generations on · 0 of its ownK223765 ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc. · 2023 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · 2015 · cites it directly4descendants
- K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019 · 2 generations on3descendants
- K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019 · 3 generations on2descendants
- K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022 · 4 generations on1descendant
- K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc. · 2023 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K923056 | Neurosign Model 100 | The Magstim Company, Ltd. | 1992 | 1 |
| −4 | K991583 | Neurosign 400, 4 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1999 | — |
| −3 | K050325 | Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar… | Technomed Europe | 2005 | — |
| −2 | K062996 | Disposable Monopolar and Bipolar Stimulator Probes | Axon Systems, Inc. | 2007 | — |
| −1 | K063729 | Disposable Pedicle Screw Probe, Model 3603-00 | Technomed Europe | 2007 | — |
| 0 (this device) | K073229 | Nerve Monitoring Cable | Pioneer Surgical Technology | 2008 | — |
| +1 | K142438 | Nerve Monitoring Cable System | Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) | 2015 | — |
| +2 | K182617 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
| +3 | K191723 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
| +4 | K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2022 | — |
| +5 | K223765 | ATEC Lateral Navigation Instruments | Alphatec Spine, Inc. | 2023 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (6)
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 |
|---|---|---|---|
| * | K063729 | Disposable Pedicle Screw Probe, Model 3603-00Summary page 1…882.1350 Regulation Name: Needle electrode Classification Product Code: GXZ Predicate Device: K063729 - Disposable Pedicle Screw Probe, Technomed Europe K063305 - Stimulating Bur Guard, Medtronic Xomed… | 2007 |
| * | K063305 | Stimulating Bur GuardSummary page 1…Classification Product Code: GXZ Predicate Device: K063729 - Disposable Pedicle Screw Probe, Technomed Europe K063305 - Stimulating Bur Guard, Medtronic Xomed K013215 & K002677 - Intraoperative Nerve Surveillance, Nuvasi… | 2006 |
| * | K013215 | Modified Ins-1 Intraoperative Nerve Surveillance SystemSummary page 1…K063729 - Disposable Pedicle Screw Probe, Technomed Europe K063305 - Stimulating Bur Guard, Medtronic Xomed K013215 & K002677 - Intraoperative Nerve Surveillance, Nuvasive K062996 & K050194 - Disp. Monopolar and Bipola… | 2001 |
| * | K002677 | Nuvasive Ins-1 Intraoperative Nerve Surveillance SystemSummary page 1…63729 - Disposable Pedicle Screw Probe, Technomed Europe K063305 - Stimulating Bur Guard, Medtronic Xomed K013215 & K002677 - Intraoperative Nerve Surveillance, Nuvasive K062996 & K050194 - Disp. Monopolar and Bipolar Stimulat… | 2000 |
| * | K062996 | Disposable Monopolar and Bipolar Stimulator ProbesSummary page 1…K063305 - Stimulating Bur Guard, Medtronic Xomed K013215 & K002677 - Intraoperative Nerve Surveillance, Nuvasive K062996 & K050194 - Disp. Monopolar and Bipolar Stimulator Probes & Subdermal Needle Electrodes, -, Axon Syste… | 2007 |
| * | K050194 | Axon Systems Subdermal Needle ElectrodesSummary page 1…- Stimulating Bur Guard, Medtronic Xomed K013215 & K002677 - Intraoperative Nerve Surveillance, Nuvasive K062996 & K050194 - Disp. Monopolar and Bipolar Stimulator Probes & Subdermal Needle Electrodes, -, Axon Systems, Inc… | 2005 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142438 | Nerve Monitoring Cable System | 2015 | 4 |
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 16 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 32 ancestors have a recall of any class.
- Of its descendants, K142438 (Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.), 2015) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K063729.
How does its category compare?
All GXZ devicesGXZ Electrode, Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Pioneer Nerve Monitoring Cable, in conjunction with Pioneer pedicle probes, taps, awls or screw drivers, is intended to stimulate peripheral motor nerves during surgery for the purpose of locating and identifying these nerves, including spinal nerve roots during the incision and removal of soft and hard tissue or bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073229: Nerve Monitoring Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073229
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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