510(k) · Cleared
ClearedCIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, 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 · OLO Orthopedic Stereotaxic Instrument
Cleared on Dec 23, 2020 as substantially equivalent to K183605 (Brainlab AG, 2019) after a 128-day review. Its family tree reaches back 7 generations to 1999. 1 of the 22 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Dec 23, 2020
- Review
- 128 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K983831 (1999). 12 ancestors in all, the oldest K981508 (1998). 9 later devices descend from it, 3 citing it directly. 1 of the 22 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 6 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 5 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 4 generations backK053159 Vectorvision SpineBrainlab AG · 2006 · Recalled
- 3 generations backK070106 VV Fluoro 3DBrainlab AG · 2007 · Recalled (Class I)
- 2 generations backK083310 Spine & Trauma IctBrainlab AG · 2009
- 1 generation backK183605 Spine & Trauma NavigationBrainlab AG · 2019 · Recalled
- This deviceK202320 CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module…Brainlab AG · 2020
- Descendant · cites it directly · 6 of its ownK221618 Spine & Trauma Navigation, Spine Navigation, Navigation Software…Brainlab AG · 2022
- Descendant · 2 generations on · 1 of its ownK241893 CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL · 2024
- Descendant · 2 generations on · 0 of its ownK262257 Spine Planning (3.0); Spine & Trauma Navigation; Alignment System…Brainlab SE · 2026
- Descendant · 3 generations on · 0 of its ownK254157 CROSSNAV Navigation Enabled Instruments for Disc Preparation and…Medos International SARL · 2026
- Descendant · cites it directly · 0 of its ownK252755 POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K070106 VV Fluoro 3D3 generations back · 2007
Most influential descendants
Showing 5 of 9 · See all- K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG · 2022 · cites it directly6descendants
- K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL · 2024 · 2 generations on1descendant
- K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE · 2026 · 2 generations on0descendants
- K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL · 2026 · 3 generations on0descendants
- K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −6 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −5 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −4 | K053159 | Vectorvision Spine | Brainlab AG | 2006 | 1 |
| −3 | K070106 | VV Fluoro 3D | Brainlab AG | 2007 | Class I |
| −2 | K083310 | Spine & Trauma Ict | Brainlab AG | 2009 | — |
| −1 | K183605 | Spine & Trauma Navigation | Brainlab AG | 2019 | 3 |
| 0 (this device) | K202320 | CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal… | Brainlab AG | 2020 | — |
| +1 | K221618 | Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine &… | Brainlab AG | 2022 | — |
| +2 | K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays | Medos International SARL | 2024 | — |
| +2 | K262257 | Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine | Brainlab SE | 2026 | — |
| +3 | K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | Medos International SARL | 2026 | — |
| +1 | K252755 | POINT Kinguide Agile Robotic Arm Surgical Stereotactic System | Point Robotics MedTech, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 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 |
|---|---|---|---|
| * | K183605 | Spine & Trauma NavigationSummary page 4…tory Class II Panel Orthopedic Predicate Device and K Number Spine Trauma 3D – K183605 Contact Information Primary Contact… | 2019 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K070106VV Fluoro 3DBrainlab AG · 2007 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 1 company; a new generation was cleared every 1.9 years on median.
- 4 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K221618 (Brainlab AG, 2022) has gone furthest, with 6 descendants of its own.
- 5 other devices also cite its predicate K183605.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
For spinal use the CIRQ Robotic Alignment Module is an accessory to the compatible Brainlab IGS Spinal software applications and is intended to be an intraoperative image guided localization system to support the surgeon to achieve pre-planned trajectories with surgical instruments.
The medical indications for use of the CIRQ Robotic Alignment Module for spinal use is the treatment of diseases where the placement of spinal screws is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202320: CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, 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/K202320
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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