510(k) · Cleared
ClearedES2 Neuromonitoring Accessory Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · PDQ Neurosurgical Nerve Locator
Cleared on Jul 18, 2017 as substantially equivalent to K140400 (Stryker Corporation, 2014) after a 29-day review. Its family tree reaches back 10 generations to 1995. 7 later devices descend from it.
- Decided
- Jul 18, 2017
- Review
- 29 days
- Class
- Class II
- Product code
- PDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K950697 (1995). 99 ancestors in all, the oldest K842956 (1984). 7 later devices descend from it, 3 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 deviceK171807 ES2 Neuromonitoring Accessory InstrumentsStryker Corporation · 2017
- 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 · cites it directly · 2 of its ownK190163 ALARA Neuro Access KitSurGenTec, LLC · 2019
- Descendant · 2 generations on · 1 of its ownK240664 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC · 2024
- Descendant · cites it directly · 1 of its ownK221821 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022
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 deviceK171807 ES2 Neuromonitoring Accessory InstrumentsStryker Corporation · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019 · cites it directly3descendants
- K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019 · 2 generations on2descendants
- K190163ALARA Neuro Access KitSurGenTec, LLC · 2019 · cites it directly2descendants
- K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC · 2024 · 2 generations on1descendant
- K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022 · cites it directly1descendant
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) | K171807 | ES2 Neuromonitoring Accessory Instruments | Stryker Corporation | 2017 | — |
| +1 | K182617 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
| +2 | K191723 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
| +1 | K190163 | ALARA Neuro Access Kit | SurGenTec, LLC | 2019 | — |
| +2 | K240664 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC | 2024 | — |
| +1 | K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2022 | — |
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 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 0 |
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 6 | 0 |
| 2002 | 7 | 0 |
| 2003 | 7 | 0 |
| 2004 | 6 | 0 |
| 2005 | 8 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K140400 | ES2 Neuromonitoring Accessory InstrumentsSummary page 4…y Predicate: ES2 Spinal System Neuromonitoring Accessory Instruments (K140400) Device Description: The purpose of this submission is to introduce a line extension to the ES2… | 2014 |
What descends from it? (7)
3 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 3 companies; a new generation was cleared every 1.6 years on median.
- 10 of the 99 ancestors have a recall of any class.
- Of its descendants, K182617 (Alphatec Spine, Inc., 2019) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K140400.
How does its category compare?
All PDQ devicesPDQ Neurosurgical Nerve Locator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 ES2 Neuromonitoring instruments (Awls, Taps, Screwdriver and LITe Y-NEEDLE 200, 300 and 400) can be used by the surgeon to assist in location of the spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws in open and percutaneous minimally invasive posterior surgical approaches of the non-cervical spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171807: ES2 Neuromonitoring Accessory Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171807
Report an extraction error
Are you the manufacturer?
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