510(k) · Cleared
ClearedLeksell Stereotactic System with Reusable Fixation Screws
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 May 1, 2009 as substantially equivalent to K031999 (Elekta Instrument AB, 2003) after a 445-day review. Its family tree reaches back 1 generation to 2003. 5 later devices descend from it.
- Decided
- May 1, 2009
- Review
- 445 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031999 (2003). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK031999 Elekta Leksell Stereotactic System with MR Post KitElekta Instrument AB · 2003
- This deviceK080355 Leksell Stereotactic System with Reusable Fixation ScrewsElekta Instrument AB · 2009
- Descendant · cites it directly · 4 of its ownK171123 Leksell Vantage Stereotactic SystemElekta Instrument AB · 2017 · Recalled
- Descendant · cites it directly · 3 of its ownK190887 Leksell Vantage Stereotactic SystemElekta Instrument AB · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK210700 NaviNetics D1 Stereotactic SystemNavinetics, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK261932 Leksell® Vantage Stereotactic SystemElekta Solutions AB · 2026
- Descendant · 3 generations on · 0 of its ownK231392 NaviNetics Reusable Stereotactic System (NN1000)Navinetics, Inc. · 2023 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K171123Leksell Vantage Stereotactic SystemElekta Instrument AB · 2017 · cites it directly4descendants
- K190887Leksell Vantage Stereotactic SystemElekta Instrument AB · 2019 · cites it directly3descendants
- K210700NaviNetics D1 Stereotactic SystemNavinetics, Inc. · 2021 · 2 generations on1descendant
- K261932Leksell® Vantage Stereotactic SystemElekta Solutions AB · 2026 · 2 generations on0descendants
- K231392NaviNetics Reusable Stereotactic System (NN1000)Navinetics, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031999 | Elekta Leksell Stereotactic System with MR Post Kit | Elekta Instrument AB | 2003 | — |
| 0 (this device) | K080355 | Leksell Stereotactic System with Reusable Fixation Screws | Elekta Instrument AB | 2009 | — |
| +1 | K171123 | Leksell Vantage Stereotactic System | Elekta Instrument AB | 2017 | 2 |
| +1 | K190887 | Leksell Vantage Stereotactic System | Elekta Instrument AB | 2019 | 3 |
| +2 | K210700 | NaviNetics D1 Stereotactic System | Navinetics, Inc. | 2021 | — |
| +2 | K261932 | Leksell® Vantage Stereotactic System | Elekta Solutions AB | 2026 | — |
| +3 | K231392 | NaviNetics Reusable Stereotactic System (NN1000) | Navinetics, Inc. | 2023 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 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? (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.
What descends from it? (5)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K171123 (Elekta Instrument AB, 2017) has gone furthest, with 4 descendants of its own.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Leksell Stereotactic System® with Reusable Fixation Screws is a system intended for localization and diagnosis of intracranial disorders and their surgical treatment, including radiotherapy and stereotactic radiaton therapy
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080355 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080355: Leksell Stereotactic System with Reusable Fixation Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080355
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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