510(k) · Cleared
Recalled · Class II · 2024NaviNetics Reusable Stereotactic System (NN1000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Navinetics, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Jul 14, 2023 as substantially equivalent to K210700 (Navinetics, Inc., 2021) after a 63-day review. Its family tree reaches back 5 generations to 2003. It has been recalled once.
- Decided
- Jul 14, 2023
- Review
- 63 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K031999 (2003). No later device cites it as a predicate yet.
- Root · 5 generations backK031999 Elekta Leksell Stereotactic System with MR Post KitElekta Instrument AB · 2003
- 4 generations backK080355 Leksell Stereotactic System with Reusable Fixation ScrewsElekta Instrument AB · 2009
- 3 generations backK171123 Leksell Vantage Stereotactic SystemElekta Instrument AB · 2017 · Recalled
- 2 generations backK190887 Leksell Vantage Stereotactic SystemElekta Instrument AB · 2019 · Recalled
- 1 generation backK210700 NaviNetics D1 Stereotactic SystemNavinetics, Inc. · 2021
- This deviceK231392 NaviNetics Reusable Stereotactic System (NN1000)Navinetics, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K031999 | Elekta Leksell Stereotactic System with MR Post Kit | Elekta Instrument AB | 2003 | — |
| −4 | K080355 | Leksell Stereotactic System with Reusable Fixation Screws | Elekta Instrument AB | 2009 | — |
| −3 | K171123 | Leksell Vantage Stereotactic System | Elekta Instrument AB | 2017 | 2 |
| −2 | K190887 | Leksell Vantage Stereotactic System | Elekta Instrument AB | 2019 | 3 |
| −1 | K210700 | NaviNetics D1 Stereotactic System | Navinetics, Inc. | 2021 | — |
| 0 (this device) | K231392 | NaviNetics Reusable Stereotactic System (NN1000) | Navinetics, Inc. | 2023 | — |
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 HAW? 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 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 |
|---|---|---|---|
| * | K210700 | NaviNetics D1 Stereotactic SystemSummary page 4…Instrument 882.4560 HAW 21 CFR 807.92(a)(3) Product Code | Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) K210700 HAW 21 CFR 807.92(a)(4) NaviNetics D1 Stereotactic System Device Description Summary The NaviNetics Reusable Stereotactic Sys… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 26, 2024 | Class II | Z-1478-2024 | Process control | Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, the user was unable to attach the CT Localizer to perform stereotactic Imaging. Attachment of the localizer is typically accomplished by fully… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 5 ancestors have a recall of any class.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
The Intended Purpose of the NaviNetics D1 Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231392: NaviNetics Reusable Stereotactic System (NN1000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231392
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