510(k) · Cleared
ClearedVectorvision Hip 3.0
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 Aug 23, 2004 as substantially equivalent to K010602 (Brainlab AG, 2001) and 1 other predicate after a 192-day review. Its family tree reaches back 2 generations to 2001. 180 later devices descend from it.
- Decided
- Aug 23, 2004
- Review
- 192 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010612 (2001). 3 ancestors in all. 180 later devices descend from it, 12 citing it directly.
- Root · 2 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 1 generation backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- This deviceK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- Descendant · cites it directly · 170 of its ownK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- Descendant · cites it directly · 154 of its ownK060468 Vectorvision HipBrainlab AG · 2006
- Descendant · cites it directly · 84 of its ownK072716 Vector Vision HipBrainlab AG · 2007
- Descendant · 2 generations on · 81 of its ownK070731 Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007
- Descendant · 3 generations on · 79 of its ownK080875 Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008
Showing 5 of 180 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 180 · See all- K052213Navigation SW Hip 3.1 on CIBrainlab AG · 2005 · cites it directly170descendants
- K060468Vectorvision HipBrainlab AG · 2006 · cites it directly154descendants
- K072716Vector Vision HipBrainlab AG · 2007 · cites it directly84descendants
- K070731Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007 · 2 generations on81descendants
- K080875Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008 · 3 generations on79descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −1 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| 0 (this device) | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| +1 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| +1 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| +1 | K072716 | Vector Vision Hip | Brainlab AG | 2007 | — |
| +2 | K070731 | Pigalileo Total Hip Replacement (THR) System | Plus Orthopedics AG | 2007 | — |
| +3 | K080875 | Pigalileo 4TH Generation System | Smith & Nephew, Inc. | 2008 | — |
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 | 4 | 0 |
| 2007 | 7 | 0 |
| 2008 | 1 | 0 |
| 2009 | 6 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 18 | 0 |
| 2018 | 6 | 0 |
| 2019 | 11 | 0 |
| 2020 | 19 | 0 |
| 2021 | 12 | 0 |
| 2022 | 5 | 0 |
| 2023 | 11 | 0 |
| 2024 | 15 | 0 |
| 2025 | 11 | 0 |
| 2026 | 20 | 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 |
|---|---|---|---|
| * | K010602 | Vectorvision HipSummary page 1…VectorVision® Hip, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic Predicate Device Vector Vision® Hip (K010602) Device Classificati )n Name: Instrument, Stereotaxic Regulatory Class: I'lass II Intended Use: BrainLAB VectorV sion is intend… | 2001 |
| * | K021306 | Vectorvision CT-Free KneeSummary page 2…was found to be substantially equivalent with predicate devices such as the 510(k)-clearance of: - VectorVision® Hip (K010602) - Vector Vision® CT-free Knee (K021306) -+ 0f%.~ Public Healt… | 2002 |
What descends from it? (180)
See all 18012 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052213 | Navigation SW Hip 3.1 on CI | 2005 | 170 |
| K060468 | Vectorvision Hip | 2006 | 154 |
| K072716 | Vector Vision Hip | 2007 | 84 |
| K060727 | Vectorvision Hip | 2006 | 71 |
| K083483 | Brainlab Hip Unlimited, CI Hip Unlimited | 2009 | 70 |
| K083644 | Mako Surgical Tactile Guidance System-Hip | 2009 | 13 |
| K091998 | Robotic Arm Interactive Orthopedic System-Hip | 2009 | 12 |
| K093425 | Mako Surgical Corp Robotic Arm Interactive Orthopedic System-Tha | 2010 | 11 |
| K063028 | Vectorvision Hip SR | 2006 | 11 |
| K052178 | Depuy Cas Hip Instrumentation | 2005 | 2 |
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 3 years and passes through 1 company; a new generation was cleared every 1.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K052213 (Brainlab AG, 2005) has gone furthest, with 170 descendants of its own.
- 8 other devices also cite its predicate K010602.
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. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space either on a patient's preoperative image data being processed by a Vector vision workstation or 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…
Read the full statement (154 words)
BrainLAB VectorVision is intended to be an intraoperative image guided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space either on a patient's preoperative image data being processed by a Vector vision workstation or 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 hip endoprothesis to the preoperatively or intraoperatively planned position.
Example orthopedic surgical procedures include but are not limited to:
Total Joint Replacement (TJR)
Revision surgery of TJR
Tumor resection and bone/joint reconstruction
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040368 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040368: Vectorvision Hip 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040368
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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