510(k) · Cleared
ClearedDisposable Pedicle Screw Probe, Model 3603-00
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Technomed Europe · GXZ Electrode, Needle
Cleared on Aug 21, 2007 as substantially equivalent to K062996 (Axon Systems, Inc., 2007) after a 249-day review. Its family tree reaches back 4 generations to 1992. 19 later devices descend from it.
- Decided
- Aug 21, 2007
- Review
- 249 days
- Class
- Class II
- Product code
- GXZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K923056 (1992). 7 ancestors in all. 19 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK923056 Neurosign Model 100The Magstim Company, Ltd. · 1992 · Recalled
- 3 generations backK991583 Neurosign 400, 4 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1999
- 2 generations backK050325 Disposable Concentric Probe, Disposable Bipolar Probe, Disposable…Technomed Europe · 2005
- 1 generation backK062996 Disposable Monopolar and Bipolar Stimulator ProbesAxon Systems, Inc. · 2007
- This deviceK063729 Disposable Pedicle Screw Probe, Model 3603-00Technomed Europe · 2007
- Descendant · cites it directly · 17 of its ownK103128 Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip…Cadwell Lab, Inc. · 2011
- Descendant · 2 generations on · 10 of its ownK111597 Disposable Stimulating ElectrodeNuvasive, Inc. · 2011
- Descendant · 3 generations on · 9 of its ownK112709 Stimulation/Dissection InstrumentsNu Vasive, Incorporated · 2012
- Descendant · 2 generations on · 5 of its ownK132373 Biomet Access SystemBiomet Spine (Aka Ebi, LLC) · 2014
- Descendant · cites it directly · 5 of its ownK073229 Nerve Monitoring CablePioneer Surgical Technology · 2008
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K103128Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw…Cadwell Lab, Inc. · 2011 · cites it directly17descendants
- K111597Disposable Stimulating ElectrodeNuvasive, Inc. · 2011 · 2 generations on10descendants
- K112709Stimulation/Dissection InstrumentsNu Vasive, Incorporated · 2012 · 3 generations on9descendants
- K132373Biomet Access SystemBiomet Spine (Aka Ebi, LLC) · 2014 · 2 generations on5descendants
- K073229Nerve Monitoring CablePioneer Surgical Technology · 2008 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K923056 | Neurosign Model 100 | The Magstim Company, Ltd. | 1992 | 1 |
| −3 | K991583 | Neurosign 400, 4 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1999 | — |
| −2 | K050325 | Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar… | Technomed Europe | 2005 | — |
| −1 | K062996 | Disposable Monopolar and Bipolar Stimulator Probes | Axon Systems, Inc. | 2007 | — |
| 0 (this device) | K063729 | Disposable Pedicle Screw Probe, Model 3603-00 | Technomed Europe | 2007 | — |
| +1 | K103128 | Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip… | Cadwell Lab, Inc. | 2011 | — |
| +2 | K111597 | Disposable Stimulating Electrode | Nuvasive, Inc. | 2011 | — |
| +3 | K112709 | Stimulation/Dissection Instruments | Nu Vasive, Incorporated | 2012 | — |
| +2 | K132373 | Biomet Access System | Biomet Spine (Aka Ebi, LLC) | 2014 | — |
| +1 | K073229 | Nerve Monitoring Cable | Pioneer Surgical Technology | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 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? (1)
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 |
|---|---|---|---|
| * | K062996 | Disposable Monopolar and Bipolar Stimulator Probes Cleared while this submission was under review Summary page 1…sual Name: Disposable probe for stimulating electrode Classification Name: Needle electrode (21 CFR section 882.1350) Substantial Equivalence: K062996: Disposable probe for pedicle hole stimulation Disposable pedicle screw probes are used as the… | 2007 |
What descends from it? (19)
See all 192 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 15 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K103128 (Cadwell Lab, Inc., 2011) has gone furthest, with 17 descendants of its own.
- 6 other devices also cite its predicate K062996.
How does its category compare?
All GXZ devicesGXZ Electrode, Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 disposable pedicle screw probe is used to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063729 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063729: Disposable Pedicle Screw Probe, Model 3603-00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063729
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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