510(k) · Cleared
ClearedAlignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT
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 Jan 28, 2025 as substantially equivalent to K191597 (Medtronic Navigation, Inc., 2019) and 1 other predicate after a 60-day review. Its family tree reaches back 13 generations to 1986. 3 of the 103 devices in its family, counting itself, have a Class I recall.
- Decided
- Jan 28, 2025
- Review
- 60 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K862807 (1986). 102 ancestors in all, the oldest K811452 (1981). No later device cites it as a predicate yet. 3 of the 103 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 9 generations between
- 3 generations backK191597 Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. · 2019 · Recalled
- 2 generations backK210989 Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module…Brainlab AG · 2021
- 1 generation backK223864 Alignment System Cranial, Alignment Software Cranial, Cirq Alignment…Brainlab AG · 2023
- This deviceK243698 Alignment System Cranial, with Alignment Software Cranial with LITT…Brainlab AG · 2025
Show all 13 generations
- Root · 13 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 12 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 11 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 10 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 9 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 8 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 7 generations backK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- 6 generations backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- 5 generations backK121264 Triton Electric High Torque Handpiece and Software ModuleMedtronic Surgical Technologies · 2012
- 4 generations backK170312 IPC systems, Legend EHS handpieces and Legend Stylus Touch…Medtronic Powered Surgical Solutions · 2017
- 3 generations backK191597 Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. · 2019 · Recalled
- 2 generations backK210989 Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module…Brainlab AG · 2021
- 1 generation backK223864 Alignment System Cranial, Alignment Software Cranial, Cirq Alignment…Brainlab AG · 2023
- This deviceK243698 Alignment System Cranial, with Alignment Software Cranial with LITT…Brainlab AG · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −12 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −11 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −10 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −9 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −8 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| −7 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
| −6 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| −5 | K121264 | Triton Electric High Torque Handpiece and Software Module | Medtronic Surgical Technologies | 2012 | — |
| −4 | K170312 | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw… | Medtronic Powered Surgical Solutions | 2017 | — |
| −3 | K191597 | Stealth Autoguide System, Midas Rex Legend Depth Stop System | Medtronic Navigation, Inc. | 2019 | 1 |
| −2 | K210989 | Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial… | Brainlab AG | 2021 | — |
| −1 | K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software… | Brainlab AG | 2023 | — |
| 0 (this device) | K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq… | Brainlab AG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 8 | 0 |
| 2001 | 5 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2005 | 7 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 1 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 1 |
| 2015 | 1 | 1 |
| 2017 | 1 | 0 |
| 2020 | 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.
3 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K191597 | Stealth Autoguide System, Midas Rex Legend Depth Stop SystemSummary page 5…882.4560 Regulatory Class Class II Panel Neurology Predicate Device(s) Primary Predicate: K191597 Stealth Autoguide System Secondary Predicate: K223864 Alignment System Cranial… | 2019 |
| * | K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Summary page 5…Neurology Predicate Device(s) Primary Predicate: K191597 Stealth Autoguide System Secondary Predicate: K223864 Alignment System Cranial Contact Information Primary Contact… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K151359ROSA BrainMedtech S.A · 2015 · 2 generations back · ◆ in the 2015 ancestors bar of FIG. 11 Class I recall
- K092467Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential, Cranial UnlimitedBrainlab AG · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
- K070106VV Fluoro 3DBrainlab AG · 2007 · 3 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 39 years and passes through 8 companies; a new generation was cleared every 2.0 years on median.
- 18 of the 102 ancestors have a recall of any class; 3 have a Class I recall.
- 3 other devices also cite its predicate K191597.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Alignment System Cranial is intended to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures.
The indications for use are biopsy of intracranial lesions, placement of stereoelectroencephalography (SEEG) electrodes and placement of anchor bolts for laser interstitial thermal therapy (LITT).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243698 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243698: Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243698
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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