510(k) · Cleared
Recalled · 2009Leksell 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 Mar 2, 1998 as substantially equivalent to K934523 (Radionics, Inc., 1995) and 1 other predicate after a 252-day review. Its family tree reaches back 1 generation to 1990. 7 later devices descend from it. It has been recalled once.
- Decided
- Mar 2, 1998
- Review
- 252 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K892425 (1990). 2 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK892425 STP Complete Module SetLeibinger & Fischer, Ltd. · 1990
- This deviceK972324 Leksell Stereotactic SystemElekta Instrument AB · 1998
- Descendant · cites it directly · 4 of its ownK092192 Waypoint Stereotactic SystemFHC, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK132611 Microtable SystemFred Haer Company, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK233703 Bone Anchor (NGS-BA-01)ClearPoint Neuro, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK231141 STarFix Designer Software C0265FHC, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK223552 Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy…Brainlab AG · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K092192Waypoint Stereotactic SystemFHC, Inc. · 2010 · cites it directly4descendants
- K132611Microtable SystemFred Haer Company, Inc. · 2014 · 2 generations on1descendant
- K233703Bone Anchor (NGS-BA-01)ClearPoint Neuro, Inc. · 2024 · 3 generations on0descendants
- K231141STarFix Designer Software C0265FHC, Inc. · 2023 · 2 generations on0descendants
- K223552Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead…Brainlab AG · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K892425 | STP Complete Module Set | Leibinger & Fischer, Ltd. | 1990 | — |
| 0 (this device) | K972324 | Leksell Stereotactic System | Elekta Instrument AB | 1998 | — |
| +1 | K092192 | Waypoint Stereotactic System | FHC, Inc. | 2010 | — |
| +2 | K132611 | Microtable System | Fred Haer Company, Inc. | 2014 | — |
| +3 | K233703 | Bone Anchor (NGS-BA-01) | ClearPoint Neuro, Inc. | 2024 | — |
| +2 | K231141 | STarFix Designer Software C0265 | FHC, Inc. | 2023 | — |
| +2 | K223552 | Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements… | Brainlab AG | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K934523 | Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth Confirmation Helmet…Summary page 2…Response to 510(k) #K972324 Deficiencies February 16, 1998 183 IDENTIFICATION OF PREDICATE DEVICE Company Device 510(k) No. Date Cleared Radionics Cosman-Robert-Wells K934523 February §, 1995 Stereotactic System Leibinger & 7D Neurosurgical K892425 March 23, 1990 F.L. Fischer Localizing Unit 18.4 DEV… | 1995 |
| * | K892425 | STP Complete Module SetSummary page 2…ION OF PREDICATE DEVICE Company Device 510(k) No. Date Cleared Radionics Cosman-Robert-Wells K934523 February §, 1995 Stereotactic System Leibinger & 7D Neurosurgical K892425 March 23, 1990 F.L. Fischer Localizing Unit 18.4 DEVICE DESCRIPTION The Leksell Stereotactic System is a stereotaxic instramen… | 1990 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 2, 2009 | Not classified | Z-1251-2011 | Labeling design | New protocols for MR sequences may result in higher RF energies deposited during MR scanning, generating heat in uninsulated fixation posts. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 is a system intended for localization (spatial reference) for cranial surgery using X-Ray, or CT and MRI image data.
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/K972324 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972324: Leksell Stereotactic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972324
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