510(k) · Cleared
ClearedBrainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial
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 Apr 19, 2023 as substantially equivalent to K211544 (Brainlab AG, 2021) and 1 other predicate after a 145-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Apr 19, 2023
- Review
- 145 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K983410 (1999). 18 ancestors in all, the oldest K854886 (1986). No later device cites it as a predicate yet.
- Root · 6 generations backK983410 @ TargetBrainlab AG · 1999
- 5 generations backK020631 IPLANBrainlab AG · 2002
- 4 generations backK041703 IPLAN!Brainlab AG · 2004
- 3 generations backK053127 IPLANBrainlab AG · 2006
- 2 generations backK101627 IPLANBrainlab AG · 2011
- 1 generation backK211544 Trajectory Planning, Elements Trajectory Planning, Elements Lead…Brainlab AG · 2021
- This deviceK223552 Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy…Brainlab AG · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K983410 | @ Target | Brainlab AG | 1999 | — |
| −5 | K020631 | IPLAN | Brainlab AG | 2002 | — |
| −4 | K041703 | IPLAN! | Brainlab AG | 2004 | — |
| −3 | K053127 | IPLAN | Brainlab AG | 2006 | — |
| −2 | K101627 | IPLAN | Brainlab AG | 2011 | — |
| −1 | K211544 | Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization | Brainlab AG | 2021 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 4 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K211544 | Trajectory Planning, Elements Trajectory Planning, Elements Lead LocalizationSummary page 4…HAW Regulation Number 882.4560 Regulatory Class II Panel Neurology Primary Predicate Device (K211544) Brainlab Elements Trajectory Planning (2.5) Additional Predicate Device (K092192) Waypoint Stereotactic System… | 2021 |
| * | K092192 | Waypoint Stereotactic SystemSummary page 4…II Panel Neurology Primary Predicate Device (K211544) Brainlab Elements Trajectory Planning (2.5) Additional Predicate Device (K092192) Waypoint Stereotactic System Contact Information Primary Contact Sadwini S… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 1 company; a new generation was cleared every 3.0 years on median.
- 3 of the 18 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?
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 (105 words)
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 as stated in the FDA summary.
https://510kreport.com/device/K223552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223552: Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223552
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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