510(k) · Cleared
ClearedNerve Monitoring Cable System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · PDQ Neurosurgical Nerve Locator
Cleared on Mar 5, 2015 as substantially equivalent to K073229 (Pioneer Surgical Technology, 2008) and 2 other predicates after a 188-day review. Its family tree reaches back 10 generations to 1995. 4 later devices descend from it.
- Decided
- Mar 5, 2015
- Review
- 188 days
- Class
- Class II
- Product code
- PDQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K950697 (1995). 123 ancestors in all, the oldest K842956 (1984). 4 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 6 generations between
- 3 generations backK102235 Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010
- 2 generations backK122845 ES2 Spinal System Model 48280XXXXStryker Spine · 2012
- 1 generation backK140400 ES2 Neuromonitoring Accessory InstrumentsStryker Corporation · 2014
- This deviceK142438 Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · 2015
- Descendant · cites it directly · 3 of its ownK182617 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK191723 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
- Descendant · 3 generations on · 1 of its ownK221821 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022
- Descendant · 4 generations on · 0 of its ownK223765 ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc. · 2023 · Recalled
Show all 10 generations
- Root · 10 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 9 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 8 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 7 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 6 generations backK061854 Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemStryker Spine · 2006
- 5 generations backK063428 Xia Stainless Steel Spinal SystemStryker Spine · 2006
- 4 generations backK092631 Mantis Redux Spinal SystemStryker Spine · 2009
- 3 generations backK102235 Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010
- 2 generations backK122845 ES2 Spinal System Model 48280XXXXStryker Spine · 2012
- 1 generation backK140400 ES2 Neuromonitoring Accessory InstrumentsStryker Corporation · 2014
- This deviceK142438 Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · 2015
Most influential descendants
Showing 4 of 4 · See all- K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019 · cites it directly3descendants
- K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019 · 2 generations on2descendants
- K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022 · 3 generations on1descendant
- K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −9 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −8 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −7 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −6 | K061854 | Xia Titanium Spinal System and Xia Stainless Steel Spinal System | Stryker Spine | 2006 | — |
| −5 | K063428 | Xia Stainless Steel Spinal System | Stryker Spine | 2006 | — |
| −4 | K092631 | Mantis Redux Spinal System | Stryker Spine | 2009 | — |
| −3 | K102235 | Mantis Spinal System & Mantis Redux Spinal System | Stryker Spine | 2010 | — |
| −2 | K122845 | ES2 Spinal System Model 48280XXXX | Stryker Spine | 2012 | — |
| −1 | K140400 | ES2 Neuromonitoring Accessory Instruments | Stryker Corporation | 2014 | — |
| 0 (this device) | K142438 | Nerve Monitoring Cable System | Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) | 2015 | — |
| +1 | K182617 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
| +2 | K191723 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
| +3 | K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2022 | — |
| +4 | K223765 | ATEC Lateral Navigation Instruments | Alphatec Spine, Inc. | 2023 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 6 | 0 |
| 1996 | 3 | 0 |
| 1997 | 6 | 0 |
| 1998 | 3 | 0 |
| 1999 | 8 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 8 | 0 |
| 2003 | 8 | 0 |
| 2004 | 6 | 0 |
| 2005 | 10 | 0 |
| 2006 | 8 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K073229 | Nerve Monitoring CableSummary page 4…21 CFR 874.1820, PDQ, Neurosurgical nerve locator and ETN, Nerve stimulator 21 CFR 882.1350, GXZ, Needle electrode Predicate K073229 Pioneer Surgical Technology, Inc. - Nerve Monitoring Cable System Devices: K132373 Biomet Spine - Biomet Probes/Guidewir… | 2008 |
| * | K132373 | Biomet Access SystemSummary page 4…or 21 CFR 882.1350, GXZ, Needle electrode Predicate K073229 Pioneer Surgical Technology, Inc. - Nerve Monitoring Cable System Devices: K132373 Biomet Spine - Biomet Probes/Guidewires and Dilators K140400 Stryker Spine - ES2® Neuromonitoring Accessory Ins… | 2014 |
| * | K140400 | ES2 Neuromonitoring Accessory InstrumentsSummary page 4…073229 Pioneer Surgical Technology, Inc. - Nerve Monitoring Cable System Devices: K132373 Biomet Spine - Biomet Probes/Guidewires and Dilators K140400 Stryker Spine - ES2® Neuromonitoring Accessory Instruments Device The Nerve Monitoring Cable System, which consists of… | 2014 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182617 | ATEC IOM Accessory Instruments | 2019 | 3 |
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 20 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 12 of the 123 ancestors have a recall of any class.
- Of its descendants, K182617 (Alphatec Spine, Inc., 2019) has gone furthest, with 3 descendants of its own.
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 Nerve Monitoring Cable in conjunction with dilators, pedicle probes, taps, awls or screw drivers, are intended for
tissue dilation/dissection and stimulation of peripheral nerves including spinal nerve roots for location and identification
during spinal surgery.
The dilators are also intended for use in surgical procedures to provide surgical access by dilating the soft tissue to the
intended surgical site to allow passage of current from a point on the proximal end to an uninsulated portion of the distal
tip. The purpose of this is to allow controlled monitoring of neural elements near and around the point of access. The
dilators are offered sterile/single use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142438: Nerve Monitoring Cable System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142438
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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