510(k) · Cleared
ClearedCranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
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 Jul 21, 2023 as substantially equivalent to K192703 (Brainlab AG, 2020) and 2 other predicates after a 269-day review. Its family tree reaches back 6 generations to 1999. 5 of the 30 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 21, 2023
- Review
- 269 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K983831 (1999). 29 ancestors in all, the oldest K981508 (1998). No later device cites it as a predicate yet. 5 of the 30 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 5 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 4 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 3 generations backK053159 Vectorvision SpineBrainlab AG · 2006 · Recalled
- 2 generations backK070106 VV Fluoro 3DBrainlab AG · 2007 · Recalled (Class I)
- 1 generation backK192703 Cranial Image Guided Surgery System, Navigation Software Cranial…Brainlab AG · 2020
- This deviceK223288 Cranial Navigation, Navigation Software Cranial, Navigation Software…Brainlab AG · 2023
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −5 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −4 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −3 | K053159 | Vectorvision Spine | Brainlab AG | 2006 | 1 |
| −2 | K070106 | VV Fluoro 3D | Brainlab AG | 2007 | Class I |
| −1 | K192703 | Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation… | Brainlab AG | 2020 | — |
| 0 (this device) | K223288 | Cranial Navigation, Navigation Software Cranial, Navigation Software… | Brainlab AG | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 1 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 1 |
| 2017 | 2 | 1 |
| 2020 | 1 | 0 |
| 2022 | 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.
5 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? (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 |
|---|---|---|---|
| * | K192703 | Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software…Summary page 5…umber 882.4560 Regulatory Class Class II Panel Neurology Predicate Device(s) Primary Predicate: K192703 Cranial Image Guided Surgery System Secondary Predicates: K162929 Stryker Navigation System… | 2020 |
| * | K162929 | Stryker Navigation System with CranialMap software application, Stryker CranialMap…Summary page 5…Neurology Predicate Device(s) Primary Predicate: K192703 Cranial Image Guided Surgery System Secondary Predicates: K162929 Stryker Navigation System K213989 Cranial EM System… | 2017 |
| * | K213989 | Cranial EM SystemSummary page 5…e Guided Surgery System Secondary Predicates: K162929 Stryker Navigation System K213989 Cranial EM System Contact Information Primary Contact… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (5 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.
- K092467Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential, Cranial UnlimitedBrainlab AG · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
- K070106VV Fluoro 3DBrainlab AG · 2007 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · 3 generations back · ◆ in the 2017 ancestors bar of FIG. 12 Class I recalls
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 4 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 5 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 24 years and passes through 1 company; a new generation was cleared every 2.8 years on median.
- 13 of the 29 ancestors have a recall of any class; 5 have a Class I recall.
- 1 other device also cites its predicate K192703.
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?
Cranial Navigation The Cranial Navigation is intended as image-guided planning and navigation system to enable navigated cranial surgery. It links instruments to a virtual computer image space on patient image data being processed by the navigation platform. The system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy…
Read the full statement (203 words)
Cranial Navigation
The Cranial Navigation is intended as image-guided planning and navigation system to enable navigated cranial surgery.
It links instruments to a virtual computer image space on patient image data being processed by the navigation platform.
The system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified
relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy, including:
• Cranial Resection
• Resection of tumors and other lesions
• Resection of skull-base tumor or other lesions
• AVM Resection
• Craniofacial Procedures (including cranial and midfacial bones)
• Tumor Resection
• Bone Tumor Defect Reconstruction
• Bone Trauma Defect Reconstruction
• Bone Congenital Defect Reconstructions
• Orbital cavity reconstruction procedures
• Removal of foreign objects
Cranial EM System
Cranial EM is intended as an image-guided planning and navigation system to enable neurosurgery procedures.
The device is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified
relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy, such as:
• Cranial Resection
o Resection of tumors and other lesions
o Resection of skull-base tumor or other lesions
• Intracranial catheter placement
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223288: Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223288
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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