510(k) · Cleared
ClearedVectorvision Hip SR
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 Dec 12, 2006 as substantially equivalent to K040368 (Brainlab AG, 2004) and 1 other predicate after a 71-day review. Its family tree reaches back 3 generations to 2001. 11 later devices descend from it.
- Decided
- Dec 12, 2006
- Review
- 71 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K010612 (2001). 5 ancestors in all. 11 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 2 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 1 generation backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- This deviceK063028 Vectorvision Hip SRBrainlab AG · 2006
- Descendant · cites it directly · 5 of its ownK122011 Navigation Software Hip-Universal; Navigation Software Hip…Brainlab AG · 2012 · Recalled
- Descendant · 2 generations on · 3 of its ownK181449 Ortoma Treatment Solution - OTSOrtoma AB · 2018
- Descendant · 3 generations on · 2 of its ownK232140 OTS HipOrtoma AB · 2024 · Recalled
- Descendant · cites it directly · 2 of its ownK071929 Navitrack System- Partial Hip Resurfacing UniversalOrthosoft, Inc. · 2007 · Recalled
- Descendant · 4 generations on · 1 of its ownK250086 OTS HipOrtoma AB · 2025 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG · 2012 · cites it directly5descendants
- K181449Ortoma Treatment Solution - OTSOrtoma AB · 2018 · 2 generations on3descendants
- K232140OTS HipOrtoma AB · 2024 · 3 generations on2descendants
- K071929Navitrack System- Partial Hip Resurfacing UniversalOrthosoft, Inc. · 2007 · cites it directly2descendants
- K250086OTS HipOrtoma AB · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −2 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −1 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| 0 (this device) | K063028 | Vectorvision Hip SR | Brainlab AG | 2006 | — |
| +1 | K122011 | Navigation Software Hip-Universal; Navigation Software Hip THR-Aesculap | Brainlab AG | 2012 | 1 |
| +2 | K181449 | Ortoma Treatment Solution - OTS | Ortoma AB | 2018 | — |
| +3 | K232140 | OTS Hip | Ortoma AB | 2024 | 1 |
| +1 | K071929 | Navitrack System- Partial Hip Resurfacing Universal | Orthosoft, Inc. | 2007 | 3 |
| +4 | K250086 | OTS Hip | Ortoma AB | 2025 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K040368 | Vectorvision Hip 3.0Summary page 1…VectorVision®, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic Predicate Device: VectorVision® hip (K040368) VectorVision® osteotomy (K042513) Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II Inten… | 2004 |
| * | K042513 | Vectorvision OsteotomySummary page 1…ided Surgery System / Instrument, Stereotaxic Predicate Device: VectorVision® hip (K040368) VectorVision® osteotomy (K042513) Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II Intended Use: BrainLAB's VectorVision®… | 2005 |
What descends from it? (11)
See all 114 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 5 years and passes through 1 company; a new generation was cleared every 1.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K122011 (Brainlab AG, 2012) has gone furthest, with 5 descendants of its own.
- 11 other devices also cite its predicate K040368.
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® hip SR is intended as an intraoperative image-guided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a VectorVision® navigation station. The image data is provided either in the form of preoperatively-acquired patient images or in the form of an individual 3D model of the patient's bone, which is generated by acquiring multiple landmarks on the bone…
Read the full statement (154 words)
BrainLAB's VectorVision® hip SR is intended as an intraoperative image-guided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a VectorVision® navigation station. The image data is provided either in the form of preoperatively-acquired patient images or in the form of an individual 3D model of the patient's bone, which is generated by acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be considered to 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, or MR-based model of the anatomy. The system aids the surgeon in accurately navigating a hip endoprothesis to the preoperatively or intraoperatively planned position.
Example orthopedic surgical procedures include but are not limited to:
Partial/hemi-hip resurfacing
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063028 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063028: Vectorvision Hip SR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063028
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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