510(k) · Cleared
Recalled · Class II · 2013Vectorvision Spine
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 Jun 6, 2006 as substantially equivalent to K010968 (Brainlab AG, 2001) and 1 other predicate after a 204-day review. Its family tree reaches back 3 generations to 1999. 1 of the 162 devices in its family, counting itself, has a Class I recall. 155 later devices descend from it. It has been recalled once.
- Decided
- Jun 6, 2006
- Review
- 204 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K983831 (1999). 6 ancestors in all. 155 later devices descend from it, 3 citing it directly. 1 of the 162 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 2 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 1 generation backK042721 Kolibri SpineBrainlab AG · 2005
- This deviceK053159 Vectorvision SpineBrainlab AG · 2006
- Descendant · cites it directly · 119 of its ownK070106 VV Fluoro 3DBrainlab AG · 2007 · Recalled (Class I)
- Descendant · 2 generations on · 53 of its ownK081386 Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A. · 2008 · Recalled
- Descendant · 3 generations on · 51 of its ownK091009 MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY…Esaote, S.p.A. · 2009
- Descendant · 3 generations on · 46 of its ownK100931 Mylabtwice, Model 6200Esaote, S.p.A. · 2010
- Descendant · 2 generations on · 40 of its ownK083310 Spine & Trauma IctBrainlab AG · 2009
Showing 5 of 155 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K070106 VV Fluoro 3Dcites it directly · 2007
Most influential descendants
Showing 5 of 155 · See all- K070106VV Fluoro 3DBrainlab AG · 2007 · cites it directly119descendants
- K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A. · 2008 · 2 generations on53descendants
- K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A. · 2009 · 3 generations on51descendants
- K100931Mylabtwice, Model 6200Esaote, S.p.A. · 2010 · 3 generations on46descendants
- K083310Spine & Trauma IctBrainlab AG · 2009 · 2 generations on40descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −2 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −1 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| 0 (this device) | K053159 | Vectorvision Spine | Brainlab AG | 2006 | — |
| +1 | K070106 | VV Fluoro 3D | Brainlab AG | 2007 | Class I |
| +2 | K081386 | Model 6150 (MYLAB70) and Model 6100 (MYLAB90) | Esaote, S.p.A. | 2008 | 2 |
| +3 | K091009 | MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY… | Esaote, S.p.A. | 2009 | — |
| +3 | K100931 | Mylabtwice, Model 6200 | Esaote, S.p.A. | 2010 | — |
| +2 | K083310 | Spine & Trauma Ict | Brainlab AG | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 1 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2016 | 6 | 0 |
| 2017 | 9 | 0 |
| 2018 | 6 | 0 |
| 2019 | 13 | 0 |
| 2020 | 10 | 0 |
| 2021 | 6 | 0 |
| 2022 | 11 | 0 |
| 2023 | 17 | 0 |
| 2024 | 21 | 0 |
| 2025 | 16 | 0 |
| 2026 | 17 | 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? (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 |
|---|---|---|---|
| * | K010968 | Vectorvision CT/FluoroSummary page 1…ision spine, BrainLAB Image Guided Surgery System! Instrument, Stereotaxic Predicate Device: BrainLAB VectorVision CT/Fluoro (K010968) BrainLAB Kolibri spine (K042721) Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II Intended Use:… | 2001 |
| * | K042721 | Kolibri SpineSummary page 1…d Surgery System! Instrument, Stereotaxic Predicate Device: BrainLAB VectorVision CT/Fluoro (K010968) BrainLAB Kolibri spine (K042721) Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II Intended Use: BrainLAB's VectorVision spine is… | 2005 |
What descends from it? (155)
See all 1553 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 15, 2013 | Class II | Z-0967-2014 | Nonconforming Material/Component | Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with specific serial numbers might have been made of an incorrect material that is not suitable for the necessary disinfection and sterilization of… |
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 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 2.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K070106 (Brainlab AG, 2007) has gone furthest, with 119 descendants of its own.
- 3 other devices also cite its predicate K010968.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for 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 image data that is processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference…
Read the full statement (178 words)
BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for 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 image data that is processed by a VectorVision workstation. 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 a CT, x-ray or MR-based model of the anatomy.
Example procedures include but are not limited to:
* Navigated spinal procedures in support of standard approaches (e.g. anterior, lateral, oblique)
* Spinal implant procedures such as
* Pedicle screw placement
* Anterior plating
* Kyphoplasty and vertebroplasty procedures
* Placement of other temporary or permanent devices such as k-wires, needles, catheters or electrodes
* Thoracic spine surgery
* Tumor surgery on the spinal column and adjacent soft tissue
* Placement of acetabular and SI screws on the pelvis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053159 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053159: Vectorvision Spine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053159
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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