510(k) · Cleared
ClearedSpine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm 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 Aug 30, 2022 as substantially equivalent to K212245 (Brainlab AG, 2022) and 2 other predicates after an 88-day review. Its family tree reaches back 8 generations to 1999. 3 of the 39 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.
- Decided
- Aug 30, 2022
- Review
- 88 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K983831 (1999). 32 ancestors in all, the oldest K981508 (1998). 6 later devices descend from it, 5 citing it directly. 3 of the 39 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 7 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 6 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 5 generations backK053159 Vectorvision SpineBrainlab AG · 2006 · Recalled
- 4 generations backK070106 VV Fluoro 3DBrainlab AG · 2007 · Recalled (Class I)
- 3 generations backK083310 Spine & Trauma IctBrainlab AG · 2009
- 2 generations backK183605 Spine & Trauma NavigationBrainlab AG · 2019 · Recalled
- 1 generation backK202320 CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module…Brainlab AG · 2020
- This deviceK221618 Spine & Trauma Navigation, Spine Navigation, Navigation Software…Brainlab AG · 2022
- Descendant · cites it directly · 1 of its ownK241893 CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL · 2024
- Descendant · cites it directly · 0 of its ownK262257 Spine Planning (3.0); Spine & Trauma Navigation; Alignment System…Brainlab SE · 2026
- Descendant · 2 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 ownK252562 Spine & Trauma Navigation InstrumentsBrainlab AG · 2025
- Descendant · cites it directly · 0 of its ownK242569 Mixed Reality Spine NavigationBrainlab AG · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL · 2024 · cites it directly1descendant
- K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE · 2026 · cites it directly0descendants
- K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL · 2026 · 2 generations on0descendants
- K252562Spine & Trauma Navigation InstrumentsBrainlab AG · 2025 · cites it directly0descendants
- K242569Mixed Reality Spine NavigationBrainlab AG · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −7 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −6 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −5 | K053159 | Vectorvision Spine | Brainlab AG | 2006 | 1 |
| −4 | K070106 | VV Fluoro 3D | Brainlab AG | 2007 | Class I |
| −3 | K083310 | Spine & Trauma Ict | Brainlab AG | 2009 | — |
| −2 | K183605 | Spine & Trauma Navigation | Brainlab AG | 2019 | 3 |
| −1 | K202320 | CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal… | Brainlab AG | 2020 | — |
| 0 (this device) | K221618 | Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine &… | Brainlab AG | 2022 | — |
| +1 | K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays | Medos International SARL | 2024 | — |
| +1 | K262257 | Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine | Brainlab SE | 2026 | — |
| +2 | K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | Medos International SARL | 2026 | — |
| +1 | K252562 | Spine & Trauma Navigation Instruments | Brainlab AG | 2025 | — |
| +1 | K242569 | Mixed Reality Spine Navigation | Brainlab AG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 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? (3)
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 |
|---|---|---|---|
| * | K212245 | Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection…Summary page 4…tion Number 882.4560 Regulatory Class Class II Panel Orthopedic Predicate Device(s) Primary Predicate: K212245 Spine & Trauma Navigation System Secondary Predicate: K110204 Brainlab Trauma… | 2022 |
| * | K110204 | Brainlab TraumaSummary page 4…Orthopedic Predicate Device(s) Primary Predicate: K212245 Spine & Trauma Navigation System Secondary Predicate: K110204 Brainlab Trauma Third Predicate: K202320 Cirq Robotic Alignment Module… | 2011 |
| * | K202320 | CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic…Summary page 4…K212245 Spine & Trauma Navigation System Secondary Predicate: K110204 Brainlab Trauma Third Predicate: K202320 Cirq Robotic Alignment Module Contact Information Primary Contact… | 2020 |
What descends from it? (6)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays | 2024 | 1 |
| K262257 | Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine | 2026 | 0 |
| K252562 | Spine & Trauma Navigation Instruments | 2025 | 0 |
| K242569 | Mixed Reality Spine Navigation | 2025 | 0 |
| K240701 | Drill Guide; Drill Bit; Spine & Trauma Navigation | 2024 | 0 |
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.
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 3 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 4 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K070106VV Fluoro 3DBrainlab AG · 2007 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 1 company; a new generation was cleared every 1.9 years on median.
- 9 of the 32 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K241893 (Medos International SARL, 2024) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K212245.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Spine & Trauma Navigation is intended as an intraoperative image-guided localization system to enable open and minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative 2D or 3D image data. Spine & Trauma Navigation enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively…
Read the full statement (188 words)
Spine & Trauma Navigation is intended as an intraoperative image-guided localization system to enable open and minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative 2D or 3D image data.
Spine & Trauma Navigation enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system. The software offers screw and interbody device planning and navigation with surgical instruments.
The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 3D fluoroscopic image reconstruction or 2D fluoroscopic image) and/or an image databased model of the anatomy.
As an accessory to the Spine & Trauma Navigation, the Alignment System Spine is intended to support the surgeon to achieve a pre-defined screw with surgical instruments during the surgical procedure. It is used for spinal screw placement procedures.
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/K221618 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221618: Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221618
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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