510(k) · Cleared
Recalled · Class II · 2026Leksell Vantage Stereotactic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta Instrument AB · HAW Neurological Stereotaxic Instrument
Cleared on Aug 1, 2019 as substantially equivalent to K080355 (Elekta Instrument AB, 2009) and 1 other predicate after a 119-day review. Its family tree reaches back 3 generations to 2003. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 1, 2019
- Review
- 119 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 3 generations to K031999 (2003). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK031999 Elekta Leksell Stereotactic System with MR Post KitElekta Instrument AB · 2003
- 2 generations backK080355 Leksell Stereotactic System with Reusable Fixation ScrewsElekta Instrument AB · 2009
- 1 generation backK171123 Leksell Vantage Stereotactic SystemElekta Instrument AB · 2017 · Recalled
- This deviceK190887 Leksell Vantage Stereotactic SystemElekta Instrument AB · 2019
- Descendant · cites it directly · 1 of its ownK210700 NaviNetics D1 Stereotactic SystemNavinetics, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK261932 Leksell® Vantage Stereotactic SystemElekta Solutions AB · 2026
- Descendant · 2 generations on · 0 of its ownK231392 NaviNetics Reusable Stereotactic System (NN1000)Navinetics, Inc. · 2023 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K210700NaviNetics D1 Stereotactic SystemNavinetics, Inc. · 2021 · cites it directly1descendant
- K261932Leksell® Vantage Stereotactic SystemElekta Solutions AB · 2026 · cites it directly0descendants
- K231392NaviNetics Reusable Stereotactic System (NN1000)Navinetics, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K031999 | Elekta Leksell Stereotactic System with MR Post Kit | Elekta Instrument AB | 2003 | — |
| −2 | K080355 | Leksell Stereotactic System with Reusable Fixation Screws | Elekta Instrument AB | 2009 | — |
| −1 | K171123 | Leksell Vantage Stereotactic System | Elekta Instrument AB | 2017 | 2 |
| 0 (this device) | K190887 | Leksell Vantage Stereotactic System | Elekta Instrument AB | 2019 | — |
| +1 | K210700 | NaviNetics D1 Stereotactic System | Navinetics, Inc. | 2021 | — |
| +1 | K261932 | Leksell® Vantage Stereotactic System | Elekta Solutions AB | 2026 | — |
| +2 | K231392 | NaviNetics Reusable Stereotactic System (NN1000) | Navinetics, Inc. | 2023 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K080355 | Leksell Stereotactic System with Reusable Fixation ScrewsSummary page 4…marketed devices to which equivalence is being claimed 510(k) # Leksell Stereotactic System K080355 Leksell® Vantage™ Stereotactic System (Primary) K171123 7. Other relevant submi… | 2009 |
| * | K171123 | Leksell Vantage Stereotactic SystemSummary page 4…Stereotactic System K080355 Leksell® Vantage™ Stereotactic System (Primary) K171123 7. Other relevant submissions N/A, no other relevant submissions 8. Device Description The Leksell® Vantage™… | 2017 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 19, 2026 | Class II | Z-2006-2026 | Device Design | Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures. |
| Sep 30, 2025 | Class II | Z-0433-2026 | Process change control | Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound |
| Mar 30, 2020 | Class II | Z-1826-2020 | Process design | A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic Arc System. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 1 company; a new generation was cleared every 5.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K210700 (Navinetics, Inc., 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K080355.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Leksell® Vantage™ 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 as stated in the FDA summary.
https://510kreport.com/device/K190887 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190887: Leksell Vantage Stereotactic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190887
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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