510(k) · Cleared
ClearedKolibri Spine
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 Apr 19, 2005 as substantially equivalent to K010968 (Brainlab AG, 2001) and 1 other predicate after a 200-day review. Its family tree reaches back 2 generations to 1999. 3 of the 193 devices in its family, counting itself, have a Class I recall. 187 later devices descend from it.
- Decided
- Apr 19, 2005
- Review
- 200 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K983831 (1999). 5 ancestors in all. 187 later devices descend from it, 4 citing it directly. 3 of the 193 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 1 generation backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- This deviceK042721 Kolibri SpineBrainlab AG · 2005
- Descendant · cites it directly · 155 of its ownK053159 Vectorvision SpineBrainlab AG · 2006 · Recalled
- Descendant · 2 generations on · 119 of its ownK070106 VV Fluoro 3DBrainlab AG · 2007 · Recalled (Class I)
- Descendant · cites it directly · 77 of its ownK062086 NavivisionBrainlab AG · 2006
- Descendant · 2 generations on · 53 of its ownK081386 Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A. · 2008 · Recalled
- Descendant · 3 generations on · 51 of its ownK091009 MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY…Esaote, S.p.A. · 2009
Showing 5 of 187 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 187 · See all- K053159Vectorvision SpineBrainlab AG · 2006 · cites it directly155descendants
- K070106VV Fluoro 3DBrainlab AG · 2007 · 2 generations on119descendants
- K062086NavivisionBrainlab AG · 2006 · cites it directly77descendants
- K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A. · 2008 · 2 generations on53descendants
- K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A. · 2009 · 3 generations on51descendants
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 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| 0 (this device) | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| +1 | K053159 | Vectorvision Spine | Brainlab AG | 2006 | 1 |
| +2 | K070106 | VV Fluoro 3D | Brainlab AG | 2007 | Class I |
| +1 | K062086 | Navivision | Brainlab AG | 2006 | — |
| +2 | K081386 | Model 6150 (MYLAB70) and Model 6100 (MYLAB90) | Esaote, S.p.A. | 2008 | 2 |
| +3 | K091009 | MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY… | Esaote, S.p.A. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 2 | 1 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 7 | 0 |
| 2015 | 1 | 1 |
| 2016 | 7 | 0 |
| 2017 | 13 | 1 |
| 2018 | 8 | 0 |
| 2019 | 13 | 0 |
| 2020 | 13 | 0 |
| 2021 | 6 | 0 |
| 2022 | 12 | 0 |
| 2023 | 19 | 0 |
| 2024 | 23 | 0 |
| 2025 | 19 | 0 |
| 2026 | 21 | 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.
3 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K010968 | Vectorvision CT/FluoroSummary page 1…Kolibri spine, BrainLAB Image Guided Surgery System Instrument, Stereotaxic Predicate Device: BrainLAB VV CT/Fluoro (K010968) BrainLAB Kolibri Tm Image Guided Surgery System (K014256) Device Classification Name: Instrument, Stereotaxic Regulatory Cla… | 2001 |
| * | K014256 | Kolibri Igs SystemsSummary page 1…m Instrument, Stereotaxic Predicate Device: BrainLAB VV CT/Fluoro (K010968) BrainLAB Kolibri Tm Image Guided Surgery System (K014256) Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II Intended Use:… | 2002 |
What descends from it? (187)
See all 1874 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K070106VV Fluoro 3DBrainlab AG · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K143457NeuroBlate SystemMonteris Medical, Inc. · 2015 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc. · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 3.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K053159 (Brainlab AG, 2006) has gone furthest, with 155 descendants of its own.
- 3 other devices also cite its predicate K010968.
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 Kolibri spine 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 a patient's preoperative image data being processed by a Kolibri 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…
Read the full statement (154 words)
BrainLAB's Kolibri spine 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 a patient's preoperative image data being processed by a Kolibri 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, the pelvis, a long bone or vertebra can be identified relative to a CT, X-ray or MR-based model of the anatomy.
Example procedures include but are not limited to:
Spinal implant procedures such as pedicle screw placement
Kyphoplasty and Vertebroplasty procedures
Placement of other temporary or permanent devices such as k-wires, needles, catheters or electrodes
Thoracic spine surgery
Tumor surgery on the spinal column and adjacent soft tissue
Placement of acetabular and SI screws on the pelvis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042721: Kolibri Spine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042721
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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