510(k) · Cleared
ClearedVectorvision CT-Free Knee
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 Oct 25, 2002 as substantially equivalent to K010612 (Brainlab AG, 2001) after a 184-day review. Its family tree reaches back 1 generation to 2001. 387 later devices descend from it.
- Decided
- Oct 25, 2002
- Review
- 184 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010612 (2001). 387 later devices descend from it, 10 citing it directly.
- Root · 1 generation backK010612 Vectorvision KneeBrainlab AG · 2001
- This deviceK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- Descendant · cites it directly · 180 of its ownK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- Descendant · 2 generations on · 170 of its ownK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- Descendant · 2 generations on · 154 of its ownK060468 Vectorvision HipBrainlab AG · 2006
- Descendant · cites it directly · 149 of its ownK031196 Surgetics Ortho Kneelogics Navigation SystemPraxim · 2005
- Descendant · 2 generations on · 147 of its ownK060282 Total Knee Surgetics Navigation SystemPraxim S.A · 2006
Showing 5 of 387 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 387 · See all- K040368Vectorvision Hip 3.0Brainlab AG · 2004 · cites it directly180descendants
- K052213Navigation SW Hip 3.1 on CIBrainlab AG · 2005 · 2 generations on170descendants
- K060468Vectorvision HipBrainlab AG · 2006 · 2 generations on154descendants
- K031196Surgetics Ortho Kneelogics Navigation SystemPraxim · 2005 · cites it directly149descendants
- K060282Total Knee Surgetics Navigation SystemPraxim S.A · 2006 · 2 generations on147descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| 0 (this device) | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| +1 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| +2 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| +2 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| +1 | K031196 | Surgetics Ortho Kneelogics Navigation System | Praxim | 2005 | — |
| +2 | K060282 | Total Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 6 | 0 |
| 2006 | 8 | 0 |
| 2007 | 10 | 0 |
| 2008 | 8 | 0 |
| 2009 | 8 | 0 |
| 2010 | 11 | 0 |
| 2011 | 14 | 0 |
| 2012 | 9 | 0 |
| 2013 | 8 | 0 |
| 2014 | 15 | 0 |
| 2015 | 8 | 0 |
| 2016 | 12 | 0 |
| 2017 | 33 | 0 |
| 2018 | 16 | 0 |
| 2019 | 20 | 0 |
| 2020 | 30 | 0 |
| 2021 | 20 | 0 |
| 2022 | 18 | 0 |
| 2023 | 32 | 0 |
| 2024 | 30 | 0 |
| 2025 | 32 | 0 |
| 2026 | 35 | 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 |
|---|---|---|---|
| * | K010612 | Vectorvision KneeSummary page 1…ctorvision@CT-free knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic Predicate Device: Vector Vision@Knee (K 0106 12) Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II Intended Use: BrainlAB VectorVision is intended… | 2001 |
What descends from it? (387)
See all 38710 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040368 | Vectorvision Hip 3.0 | 2004 | 180 |
| K031196 | Surgetics Ortho Kneelogics Navigation System | 2005 | 149 |
| K031770 | CI TKR/Ukr | 2003 | 134 |
| K041899 | Vectorvision Uni-Knee | 2004 | 133 |
| K042512 | Vectorvision Acl | 2005 | 57 |
| K052966 | CI Knee, CI MI TKR | 2006 | 54 |
| K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited | 2008 | 52 |
| K033413 | Spineassist Device | 2004 | 35 |
| K042513 | Vectorvision Osteotomy | 2005 | 13 |
| K080678 | Uni-Knee 2.0 | 2008 | 1 |
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 Vectorvision is intended to be an 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 an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be…
Read the full statement (160 words)
BrainlAB Vectorvision is intended to be an 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 an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. 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 long bone, or vertebra, can be identified relative to a CT, X-ray, MR based model of the anatomy. The system aids the surgeon to accurately navigate a knee endoprathesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by Vectorvision@CT-free Knee.
Example orthopedic surgical procedures include but are not limited to:
Knee Procedures:
Total Knee Replacement
Unicondylar Knee Replacement
Ligament Balancing
Range of Motion Analysis
Cruciate Ligament Surgery
Patella Tracking
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021306: Vectorvision CT-Free Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021306
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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