510(k) · Cleared
ClearedCannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineguard S.A. · PDQ Neurosurgical Nerve Locator
Cleared on Jan 23, 2015 as substantially equivalent to K030526 (Spine Vision, Inc., 2004) and 1 other predicate after an 81-day review. Its family tree reaches back 5 generations to 1993. 4 later devices descend from it.
- Decided
- Jan 23, 2015
- Review
- 81 days
- Class
- Class II
- Product code
- PDQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K921979 (1993). 8 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK921979 Root ZXJ. Morita USA, Inc. · 1993
- 4 generations backK972407 Root Apex LocatorToei Electric Co., Ltd. · 1997
- 3 generations backK022020 Justwo Model Tme-601 Root Apex LocatorToei Electric Co., Ltd. · 2002
- 2 generations backK030526 Pediguard Nerve Detector SystemSpine Vision, Inc. · 2004
- 1 generation backK123390 Pediguard Nerve Detector SystemSpineguard S.A. · 2013
- This deviceK143159 Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2…Spineguard S.A. · 2015
- Descendant · cites it directly · 3 of its ownK152747 DSG Threaded Drill SystemSpineguard S.A. · 2016
- Descendant · 2 generations on · 2 of its ownK162884 SpineGuard DSG Zavation Screw SystemSpineguard S.A. · 2017
- Descendant · cites it directly · 1 of its ownK201454 DSG Connect TechnologySpineguard S.A. · 2021
- Descendant · 2 generations on · 0 of its ownK222106 Waypoint GPSWaypoint Orthopedics, Inc. · 2023
Most influential descendants
Showing 4 of 4 · See all- K152747DSG Threaded Drill SystemSpineguard S.A. · 2016 · cites it directly3descendants
- K162884SpineGuard DSG Zavation Screw SystemSpineguard S.A. · 2017 · 2 generations on2descendants
- K201454DSG Connect TechnologySpineguard S.A. · 2021 · cites it directly1descendant
- K222106Waypoint GPSWaypoint Orthopedics, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921979 | Root ZX | J. Morita USA, Inc. | 1993 | — |
| −4 | K972407 | Root Apex Locator | Toei Electric Co., Ltd. | 1997 | — |
| −3 | K022020 | Justwo Model Tme-601 Root Apex Locator | Toei Electric Co., Ltd. | 2002 | — |
| −2 | K030526 | Pediguard Nerve Detector System | Spine Vision, Inc. | 2004 | — |
| −1 | K123390 | Pediguard Nerve Detector System | Spineguard S.A. | 2013 | — |
| 0 (this device) | K143159 | Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated… | Spineguard S.A. | 2015 | — |
| +1 | K152747 | DSG Threaded Drill System | Spineguard S.A. | 2016 | — |
| +2 | K162884 | SpineGuard DSG Zavation Screw System | Spineguard S.A. | 2017 | — |
| +1 | K201454 | DSG Connect Technology | Spineguard S.A. | 2021 | — |
| +2 | K222106 | Waypoint GPS | Waypoint Orthopedics, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 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 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 |
|---|---|---|---|
| * | K030526 | Pediguard Nerve Detector SystemSummary page 4…ce Class: Class II Regulation: 21 C.F.R. §874.1820 Predicate Devices SpineGuard S.A., PediGuard Nerve Detector (K030526; K123390) Device Description The PediGuard® modular and single-piece devices are single use, devices com… | 2004 |
| * | K123390 | Pediguard Nerve Detector SystemSummary page 4…Class II Regulation: 21 C.F.R. §874.1820 Predicate Devices SpineGuard S.A., PediGuard Nerve Detector (K030526; K123390) Device Description The PediGuard® modular and single-piece devices are single use, devices composed of… | 2013 |
What descends from it? (4)
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 22 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K152747 (Spineguard S.A., 2016) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K030526.
How does its category compare?
All PDQ devicesPDQ Neurosurgical Nerve Locator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 PediGuard is indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The PediGuard System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. PediGuard is also indicated for use with…
Read the full statement (138 words)
The PediGuard is indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The PediGuard System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. PediGuard is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the spine.
The PediGuard also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143159: Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143159
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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