510(k) · Cleared
ClearedModification to Vectorvision 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 Jan 17, 2007 as substantially equivalent to K012448 (Brainlab AG, 2002) after a 156-day review. Its family tree reaches back 2 generations to 1999. 34 later devices descend from it.
- Decided
- Jan 17, 2007
- Review
- 156 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K983831 (1999). 3 ancestors in all. 34 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 1 generation backK012448 Vectorvision TraumaBrainlab AG · 2002
- This deviceK062358 Modification to Vectorvision TraumaBrainlab AG · 2007
- Descendant · cites it directly · 27 of its ownK110204 Brainlab TraumaBrainlab AG · 2011
- Descendant · cites it directly · 13 of its ownK130887 S4C Navigation InstrumentsAesculap Implant System, Inc. · 2013
- Descendant · 2 generations on · 11 of its ownK181890 Brainlab Compatible K2M Navigation InstrumentsK2m · 2018
- Descendant · 3 generations on · 9 of its ownK192911 Brainlab Compatible K2M Navigation InstrumentsK2m, Inc. · 2019
- Descendant · 4 generations on · 8 of its ownK203205 Navigated Spine InstrumentsStryker Spine · 2021
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K110204Brainlab TraumaBrainlab AG · 2011 · cites it directly27descendants
- K130887S4C Navigation InstrumentsAesculap Implant System, Inc. · 2013 · cites it directly13descendants
- K181890Brainlab Compatible K2M Navigation InstrumentsK2m · 2018 · 2 generations on11descendants
- K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc. · 2019 · 3 generations on9descendants
- K203205Navigated Spine InstrumentsStryker Spine · 2021 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −1 | K012448 | Vectorvision Trauma | Brainlab AG | 2002 | — |
| 0 (this device) | K062358 | Modification to Vectorvision Trauma | Brainlab AG | 2007 | — |
| +1 | K110204 | Brainlab Trauma | Brainlab AG | 2011 | — |
| +1 | K130887 | S4C Navigation Instruments | Aesculap Implant System, Inc. | 2013 | — |
| +2 | K181890 | Brainlab Compatible K2M Navigation Instruments | K2m | 2018 | — |
| +3 | K192911 | Brainlab Compatible K2M Navigation Instruments | K2m, Inc. | 2019 | — |
| +4 | K203205 | Navigated Spine Instruments | Stryker Spine | 2021 | — |
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 |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 6 | 0 |
| 2025 | 4 | 0 |
| 2026 | 7 | 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? (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 |
|---|---|---|---|
| * | K012448 | Vectorvision TraumaSummary page 1…VectorVision, BrainLAB Image Guided Surgery System! Instrument, Stereotaxic Predicate Device: Vector Vision traumna (K01 2448) Device Classification Name: Instrument, Stereotaxic Regulatory Class: QjWuadi Intended Use: BrainLAB VectorVision trauma is… | 2002 |
What descends from it? (34)
See all 343 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?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 4.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K110204 (Brainlab AG, 2011) has gone furthest, with 27 descendants of its own.
- 5 other devices also cite its predicate K012448.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
BrainLAB VectorVision 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 VectorVision 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 VectorVision 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 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, a bone structure like tubular bones, pelvic, calcaneus and talus, or vertebra, can be identified relative to a CT, fluoroscopic, 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 or external fixation procedures in the tubular bones.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062358 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062358: Modification to Vectorvision Trauma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062358
Report an extraction error
Are you the manufacturer?
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