510(k) · Cleared
ClearedCirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System
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 12, 2021 as substantially equivalent to K191597 (Medtronic Navigation, Inc., 2019) after a 224-day review. Its family tree reaches back 11 generations to 1986. 1 of the 91 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Nov 12, 2021
- Review
- 224 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K862807 (1986). 88 ancestors in all, the oldest K811452 (1981). 2 later devices descend from it, 1 citing it directly. 1 of the 91 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 7 generations between
- 3 generations backK121264 Triton Electric High Torque Handpiece and Software ModuleMedtronic Surgical Technologies · 2012
- 2 generations backK170312 IPC systems, Legend EHS handpieces and Legend Stylus Touch…Medtronic Powered Surgical Solutions · 2017
- 1 generation backK191597 Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. · 2019 · Recalled
- This deviceK210989 Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module…Brainlab AG · 2021
- Descendant · cites it directly · 1 of its ownK223864 Alignment System Cranial, Alignment Software Cranial, Cirq Alignment…Brainlab AG · 2023
- Descendant · 2 generations on · 0 of its ownK243698 Alignment System Cranial, with Alignment Software Cranial with LITT…Brainlab AG · 2025
Show all 11 generations
- Root · 11 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 10 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 9 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 8 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 7 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 6 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 5 generations backK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- 4 generations backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- 3 generations backK121264 Triton Electric High Torque Handpiece and Software ModuleMedtronic Surgical Technologies · 2012
- 2 generations backK170312 IPC systems, Legend EHS handpieces and Legend Stylus Touch…Medtronic Powered Surgical Solutions · 2017
- 1 generation backK191597 Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. · 2019 · Recalled
- This deviceK210989 Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module…Brainlab AG · 2021
Class I recalls in this family
- K151359 ROSA Brain2 generations back · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −10 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −9 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −8 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −7 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −6 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| −5 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
| −4 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| −3 | K121264 | Triton Electric High Torque Handpiece and Software Module | Medtronic Surgical Technologies | 2012 | — |
| −2 | K170312 | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw… | Medtronic Powered Surgical Solutions | 2017 | — |
| −1 | K191597 | Stealth Autoguide System, Midas Rex Legend Depth Stop System | Medtronic Navigation, Inc. | 2019 | 1 |
| 0 (this device) | 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 | — |
| +2 | 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 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 7 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 1 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K191597 | Stealth Autoguide System, Midas Rex Legend Depth Stop SystemSummary page 4…882.4560 Regulatory Class II Panel Neurology Predicate Device Medtronic Stealth Autoguide™ System (K191597) by Medtronic Reference Device Cirq Robotic Alignment System (K202320) by Brainlab 1. Indications for Use… | 2019 |
| † | K202320 | CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic… | 2020 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial… | 2023 | 1 |
Has anything in its family been recalled? (1 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
What does this lineage say?
- The line of descent spans 35 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 14 of the 88 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K223864 (Brainlab AG, 2023) has gone furthest, with 1 descendant of its own.
- 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. 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 Cirq Robotic Alignment Module is an intraoperative robotic positioning system and an accessory to compatible Brainlab IGS Cranial software applications. Using spatial information from an image guided navigation system, the Cirq Robotic Alignment Module enables the surgeon to align and hold surgical instruments according to pre-planned trajectories.
The Cirq Robotic Alignment Module is indicated for stereotactic biopsies of intracranial lesions.
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/K210989 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210989: Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210989
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