510(k) · Cleared
ClearedVectorvision Trauma
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 Mar 14, 2002 as substantially equivalent to K983831 (Brainlab AG, 1999) and 1 other predicate after a 225-day review. Its family tree reaches back 1 generation to 1999. 251 later devices descend from it.
- Decided
- Mar 14, 2002
- Review
- 225 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K983831 (1999). 2 ancestors in all. 251 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK983831 VECTORVISION2Brainlab AG · 1999
- This deviceK012448 Vectorvision TraumaBrainlab AG · 2002
- Descendant · cites it directly · 78 of its ownK090420 Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009
- Descendant · 2 generations on · 77 of its ownK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
- Descendant · 3 generations on · 75 of its ownK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
- Descendant · cites it directly · 71 of its ownK060727 Vectorvision HipBrainlab AG · 2006
- Descendant · 2 generations on · 70 of its ownK083483 Brainlab Hip Unlimited, CI Hip UnlimitedBrainlab AG · 2009
Showing 5 of 251 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 251 · See all- K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009 · cites it directly78descendants
- K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009 · 2 generations on77descendants
- K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · 3 generations on75descendants
- K060727Vectorvision HipBrainlab AG · 2006 · cites it directly71descendants
- K083483Brainlab Hip Unlimited, CI Hip UnlimitedBrainlab AG · 2009 · 2 generations on70descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| 0 (this device) | K012448 | Vectorvision Trauma | Brainlab AG | 2002 | — |
| +1 | K090420 | Smith & Nephew Pigalileo Screw Targeting System V 1.0 | Smith & Nephew, Inc. | 2009 | — |
| +2 | K092497 | Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 | Smith & Nephew, Inc. | 2009 | — |
| +3 | K100107 | Smith & Nephew Sureshot Distal Targeting System V2.0 | Smith & Nephew, Inc. | 2010 | 1 |
| +1 | K060727 | Vectorvision Hip | Brainlab AG | 2006 | — |
| +2 | K083483 | Brainlab Hip Unlimited, CI Hip Unlimited | Brainlab AG | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 9 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 14 | 0 |
| 2015 | 5 | 0 |
| 2016 | 11 | 0 |
| 2017 | 25 | 0 |
| 2018 | 16 | 0 |
| 2019 | 20 | 0 |
| 2020 | 22 | 0 |
| 2021 | 16 | 0 |
| 2022 | 8 | 0 |
| 2023 | 18 | 0 |
| 2024 | 19 | 0 |
| 2025 | 18 | 0 |
| 2026 | 26 | 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.
Planning a device in HAW? 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 |
|---|---|---|---|
| * | K983831 | VECTORVISION2Summary page 1…Name: Vector Vision® Trauma Common/Classification Name: VectorVision, BrainLAB tmage Guided Surgery System / Instrument, Stereotaxic Predicate Device: VectorVisionZ® (K983831) VectorVision cranial, ENT, spine {K003589) Device Classification Name : Instrument, Stereotaxic Regulatory Class: Class |l In… | 1999 |
| * | K003589 | Vectorvision Cranial, Vectorvision Spinal, Vectorvision EntSummary page 1…cation Name: VectorVision, BrainLAB tmage Guided Surgery System / Instrument, Stereotaxic Predicate Device: VectorVisionZ® (K983831) VectorVision cranial, ENT, spine {K003589) Device Classification Name : Instrument, Stereotaxic Regulatory Class: Class |l Indications for use: BrainLAB VectorVision Tr… | 2001 |
What descends from it? (251)
See all 2516 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 VectotVision Trauma is intended to be a pre- and intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient’s pre- or intraoperative image data being processed by a VectorVisian workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and…
Read the full statement (161 words)
BrainLAB VectotVision Trauma is intended to be a pre- and intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient’s pre- or intraoperative image data being processed by a VectorVisian 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, a bone structure like tubular bones, pelvic, calcaneus and talus, or vertebra, can be identified relative to a CT, fluaroscopic, X-ray or MR based model of the anatomy.
Example procedures include but are not limited to:
Spinal Procedures and spinal implant procedures such as pedicle screw placement.
Pelvis and acetabular fracture treatment such as screw placement or ilio-sacral screw fixation.
Fracture treatment procedures, such as intramedullary nailing or plating or screwing ar external fixation procedures in the tubular bones.
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/K012448 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012448: Vectorvision Trauma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012448
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026