510(k) · Cleared
ClearedSpine & Trauma Ict
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · OLO Orthopedic Stereotaxic Instrument
Cleared on Apr 1, 2009 as substantially equivalent to K070106 (Brainlab AG, 2007) after a 142-day review. Its family tree reaches back 5 generations to 1999. 1 of the 51 devices in its family, counting itself, has a Class I recall. 40 later devices descend from it.
- Decided
- Apr 1, 2009
- Review
- 142 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K983831 (1999). 10 ancestors in all, the oldest K981508 (1998). 40 later devices descend from it, 3 citing it directly. 1 of the 51 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 4 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 3 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 2 generations backK053159 Vectorvision SpineBrainlab AG · 2006 · Recalled
- 1 generation backK070106 VV Fluoro 3DBrainlab AG · 2007 · Recalled (Class I)
- This deviceK083310 Spine & Trauma IctBrainlab AG · 2009
- Descendant · cites it directly · 25 of its ownK183605 Spine & Trauma NavigationBrainlab AG · 2019 · Recalled
- Descendant · 2 generations on · 15 of its ownK212245 Spine and Trauma Navigation System, Spine & Trauma 3D Navigation…Brainlab AG · 2022
- Descendant · cites it directly · 13 of its ownK130887 S4C Navigation InstrumentsAesculap Implant System, Inc. · 2013
- Descendant · cites it directly · 11 of its ownK181890 Brainlab Compatible K2M Navigation InstrumentsK2m · 2018
- Descendant · 2 generations on · 9 of its ownK202320 CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module…Brainlab AG · 2020
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K070106 VV Fluoro 3Ddirect predicate · 2007
Most influential descendants
Showing 5 of 40 · See all- K183605Spine & Trauma NavigationBrainlab AG · 2019 · cites it directly25descendants
- K212245Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection…Brainlab AG · 2022 · 2 generations on15descendants
- K130887S4C Navigation InstrumentsAesculap Implant System, Inc. · 2013 · cites it directly13descendants
- K181890Brainlab Compatible K2M Navigation InstrumentsK2m · 2018 · cites it directly11descendants
- K202320CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic…Brainlab AG · 2020 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −4 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −3 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −2 | K053159 | Vectorvision Spine | Brainlab AG | 2006 | 1 |
| −1 | K070106 | VV Fluoro 3D | Brainlab AG | 2007 | Class I |
| 0 (this device) | K083310 | Spine & Trauma Ict | Brainlab AG | 2009 | — |
| +1 | K183605 | Spine & Trauma Navigation | Brainlab AG | 2019 | 3 |
| +2 | K212245 | Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument… | Brainlab AG | 2022 | — |
| +1 | K130887 | S4C Navigation Instruments | Aesculap Implant System, Inc. | 2013 | — |
| +1 | K181890 | Brainlab Compatible K2M Navigation Instruments | K2m | 2018 | — |
| +2 | K202320 | CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal… | Brainlab AG | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 8 | 0 |
| 2025 | 4 | 0 |
| 2026 | 10 | 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.
1 device in this family has 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 OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 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 |
|---|---|---|---|
| * | K070106 | VV Fluoro 3DSummary page 1…T Common/Classification Name: BrainLAB Image Guided Surgery System / Instrument, Stereotaxic Predicate Device: VV Fluoro 3D (K070106) Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II Intended Use: BrainLAB Spine & Trauma iCT is… | 2007 |
What descends from it? (40)
See all 403 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 1.9 years on median.
- 3 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K183605 (Brainlab AG, 2019) has gone furthest, with 25 descendants of its own.
- 9 other devices also cite its predicate K070106.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
BrainLAB Spine & Trauma iCT is intended as 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 or intraoperative 3D image data. Spine & Trauma iCT enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate…
Read the full statement (136 words)
BrainLAB Spine & Trauma iCT is intended as 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 or intraoperative 3D image data.
Spine & Trauma iCT enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system.
The software offers screw implant size planning and navigation on rigid bone structures with precalibrated and additional individually-calibrated surgical tools. 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 the acquired CT image.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083310 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083310: Spine & Trauma Ict.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083310
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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