510(k) · Cleared
ClearedTrajectory Planning, Elements Trajectory Planning, Elements Lead Localization
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · HAW Neurological Stereotaxic Instrument
Cleared on Nov 3, 2021 as substantially equivalent to K101627 (Brainlab AG, 2011) after a 168-day review. Its family tree reaches back 5 generations to 1999. 1 later device descends from it.
- Decided
- Nov 3, 2021
- Review
- 168 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K983410 (1999). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK983410 @ TargetBrainlab AG · 1999
- 4 generations backK020631 IPLANBrainlab AG · 2002
- 3 generations backK041703 IPLAN!Brainlab AG · 2004
- 2 generations backK053127 IPLANBrainlab AG · 2006
- 1 generation backK101627 IPLANBrainlab AG · 2011
- This deviceK211544 Trajectory Planning, Elements Trajectory Planning, Elements Lead…Brainlab AG · 2021
- Descendant · cites it directly · 0 of its ownK223552 Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy…Brainlab AG · 2023
Most influential descendants
Showing 1 of 1 · See all- K223552Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead…Brainlab AG · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K983410 | @ Target | Brainlab AG | 1999 | — |
| −4 | K020631 | IPLAN | Brainlab AG | 2002 | — |
| −3 | K041703 | IPLAN! | Brainlab AG | 2004 | — |
| −2 | K053127 | IPLAN | Brainlab AG | 2006 | — |
| −1 | K101627 | IPLAN | Brainlab AG | 2011 | — |
| 0 (this device) | K211544 | Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization | Brainlab AG | 2021 | — |
| +1 | 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 |
|---|---|---|
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K101627 | IPLANSummary page 4…HAW Regulation Number 882.4560 Regulatory Class Class II Panel Neurology Predicate Device(s) iPlan K101627 Contact Information Primary Contact… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223552 | Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead… | 2023 | 0 |
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 22 years and passes through 1 company; a new generation was cleared every 3.0 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K223552 (Brainlab AG, 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K101627.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Brainlab Elements Trajectory Planning software is intended for pre-, intra- and postoperative image-based planning and review of either open or minimally invasive neurosurgical and neurological procedures. Its use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate for the placement of instruments/devices and where the position of the instrument/device can be identified relative to images of the anatomy.…
Read the full statement (101 words)
The Brainlab Elements Trajectory Planning software is intended for pre-, intra- and postoperative image-based planning and review of either open or minimally invasive neurosurgical and neurological procedures.
Its use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate for the placement of instruments/devices and where the position of the instrument/device can be identified relative to images of the anatomy.
This includes, but is not limited to, the following cranial procedures (including frame-based stereotaxy and frame alternative-based stereotaxy):
Catheter placement
Depth electrode placement (SEEG procedures)
Lead placement and detection (DBS procedures)
Probe placement
Cranial biopsies
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/K211544 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211544: Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211544
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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