510(k) · Cleared
ClearedSENTIO MMG Pedicle Access Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · PDQ Neurosurgical Nerve Locator
Cleared on Mar 22, 2018 as substantially equivalent to K100992 (Innovative Surgical Solutions, LLC ("Iss"), 2010) and 1 other predicate after a 174-day review. Its family tree reaches back 8 generations to 1992. 1 later device descends from it.
- Decided
- Mar 22, 2018
- Review
- 174 days
- Class
- Class II
- Product code
- PDQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K923056 (1992). 28 ancestors in all, the oldest K842956 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK923056 Neurosign Model 100The Magstim Company, Ltd. · 1992 · Recalled
- 7 generations backK991583 Neurosign 400, 4 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1999
- 6 generations backK050325 Disposable Concentric Probe, Disposable Bipolar Probe, Disposable…Technomed Europe · 2005
- 5 generations backK062996 Disposable Monopolar and Bipolar Stimulator ProbesAxon Systems, Inc. · 2007
- 4 generations backK063729 Disposable Pedicle Screw Probe, Model 3603-00Technomed Europe · 2007
- 3 generations backK103128 Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip…Cadwell Lab, Inc. · 2011
- 2 generations backK111597 Disposable Stimulating ElectrodeNuvasive, Inc. · 2011
- 1 generation backK112709 Stimulation/Dissection InstrumentsNu Vasive, Incorporated · 2012
- This deviceK173134 SENTIO MMG Pedicle Access NeedlesMedos International SARL · 2018
- Descendant · cites it directly · 0 of its ownK223438 TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL · 2023
Most influential descendants
Showing 1 of 1 · See all- K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K923056 | Neurosign Model 100 | The Magstim Company, Ltd. | 1992 | 1 |
| −7 | K991583 | Neurosign 400, 4 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1999 | — |
| −6 | K050325 | Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar… | Technomed Europe | 2005 | — |
| −5 | K062996 | Disposable Monopolar and Bipolar Stimulator Probes | Axon Systems, Inc. | 2007 | — |
| −4 | K063729 | Disposable Pedicle Screw Probe, Model 3603-00 | Technomed Europe | 2007 | — |
| −3 | K103128 | Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip… | Cadwell Lab, Inc. | 2011 | — |
| −2 | K111597 | Disposable Stimulating Electrode | Nuvasive, Inc. | 2011 | — |
| −1 | K112709 | Stimulation/Dissection Instruments | Nu Vasive, Incorporated | 2012 | — |
| 0 (this device) | K173134 | SENTIO MMG Pedicle Access Needles | Medos International SARL | 2018 | — |
| +1 | K223438 | TELIGEN System Peripheral Motor Nerve Stimulation Indications | Medos International SARL | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 PDQ? 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 PDQ device
- #1 K243636 Neuralytix iD3 System (NTX-9001)score 16.5 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K100992 | NeuralmasSummary page 4…Regulatory Class: II Product Code & Review Panel: PDQ; Neurology D. Predicate Device Names Primary Predicate: NeuralMAS™ (K100992) Additional Predicate: NuVasive® Stimulation/Dissection Instruments (K112709)… | 2010 |
| * | K112709 | Stimulation/Dissection InstrumentsSummary page 4…rimary Predicate: NeuralMAS™ (K100992) Additional Predicate: NuVasive® Stimulation/Dissection Instruments (K112709) 5‐2 E. Device Description Th… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223438 | TELIGEN System Peripheral Motor Nerve Stimulation Indications | 2023 | 0 |
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 26 years and passes through 7 companies; a new generation was cleared every 3.5 years on median.
- 4 of the 28 ancestors have a recall of any class.
- Of its descendants, K223438 (Medos International SARL, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K100992.
How does its category compare?
All PDQ devicesPDQ Neurosurgical Nerve Locator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · PDQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PDQ
182in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDQ
No recall names PDQ since 2007.
Adverse event reports per year · PDQ
2in 2025
MAUDE reports naming product code PDQ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 5 | 181 | 0 | 1 |
| 2014 | 7 | 254 | 0 | 0 |
| 2015 | 3 | 95 | 0 | 1 |
| 2016 | 3 | 100 | 0 | 4 |
| 2017 | 2 | — | 0 | 5 |
| 2018 | 4 | 162 | 0 | 5 |
| 2019 | 4 | 182 | 0 | 10 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 2 | — | 0 | 10 |
| 2022 | 2 | — | 0 | 16 |
| 2023 | 1 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The SENTIO MMG Pedicle Access Needles are indicated for use in pedicle pilot hole preparation and stimulation of peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173134 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173134: SENTIO MMG Pedicle Access Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173134
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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