510(k) · Cleared
ClearedATEC IOM Accessory Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · PDQ Neurosurgical Nerve Locator
Cleared on Oct 18, 2019 as substantially equivalent to K182617 (Alphatec Spine, Inc., 2019) and 1 other predicate after a 113-day review. Its family tree reaches back 12 generations to 1995. 2 later devices descend from it.
- Decided
- Oct 18, 2019
- Review
- 113 days
- Class
- Class II
- Product code
- PDQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K950697 (1995). 170 ancestors in all, the oldest K842956 (1984). 2 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 8 generations between
- 3 generations backK140400 ES2 Neuromonitoring Accessory InstrumentsStryker Corporation · 2014
- 2 generations backK142438 Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · 2015
- 1 generation backK182617 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
- This deviceK191723 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK221821 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK223765 ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc. · 2023 · Recalled
Show all 12 generations
- Root · 12 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 11 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 10 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 9 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 8 generations backK061854 Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemStryker Spine · 2006
- 7 generations backK063428 Xia Stainless Steel Spinal SystemStryker Spine · 2006
- 6 generations backK092631 Mantis Redux Spinal SystemStryker Spine · 2009
- 5 generations backK102235 Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010
- 4 generations backK122845 ES2 Spinal System Model 48280XXXXStryker Spine · 2012
- 3 generations backK140400 ES2 Neuromonitoring Accessory InstrumentsStryker Corporation · 2014
- 2 generations backK142438 Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · 2015
- 1 generation backK182617 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
- This deviceK191723 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −11 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −10 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −9 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −8 | K061854 | Xia Titanium Spinal System and Xia Stainless Steel Spinal System | Stryker Spine | 2006 | — |
| −7 | K063428 | Xia Stainless Steel Spinal System | Stryker Spine | 2006 | — |
| −6 | K092631 | Mantis Redux Spinal System | Stryker Spine | 2009 | — |
| −5 | K102235 | Mantis Spinal System & Mantis Redux Spinal System | Stryker Spine | 2010 | — |
| −4 | K122845 | ES2 Spinal System Model 48280XXXX | Stryker Spine | 2012 | — |
| −3 | K140400 | ES2 Neuromonitoring Accessory Instruments | Stryker Corporation | 2014 | — |
| −2 | K142438 | Nerve Monitoring Cable System | Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) | 2015 | — |
| −1 | K182617 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
| 0 (this device) | K191723 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
| +1 | K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2022 | — |
| +2 | 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 | 2 | 0 |
| 1988 | 4 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 7 | 0 |
| 1993 | 4 | 0 |
| 1994 | 5 | 0 |
| 1995 | 7 | 0 |
| 1996 | 3 | 0 |
| 1997 | 8 | 0 |
| 1998 | 6 | 0 |
| 1999 | 10 | 0 |
| 2000 | 8 | 0 |
| 2001 | 8 | 0 |
| 2002 | 8 | 0 |
| 2003 | 10 | 0 |
| 2004 | 7 | 0 |
| 2005 | 11 | 0 |
| 2006 | 9 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K182617 | ATEC IOM Accessory InstrumentsSummary page 4…LEGALLY MARKETED PREDICATE DEVICES Predicate Device(s): 510(k) Product Name Clearance Date K182617 ATEC IOM Accessory Instruments May 9, 2019 K132138 Rhythmlink Disposable Concentric Sti… | 2019 |
| * | K132138 | Rhythmlink Disposable Concentric Stimulating ProbeSummary page 4…Product Name Clearance Date K182617 ATEC IOM Accessory Instruments May 9, 2019 K132138 Rhythmlink Disposable Concentric Stimulating Probe April 11, 2014 Page 1… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221821 | ATEC IOM Accessory Instruments | 2022 | 1 |
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 24 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 17 of the 170 ancestors have a recall of any class.
- Of its descendants, K221821 (Alphatec Spine, Inc., 2022) has gone furthest, with 1 descendant 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. 2019, 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 ATEC IOM Accessory Instruments are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191723 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191723: ATEC IOM 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/K191723
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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