510(k) · Cleared
ClearedBrainlab Trauma
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 Aug 5, 2011 as substantially equivalent to K062358 (Brainlab AG, 2007) and 2 other predicates after a 193-day review. Its family tree reaches back 6 generations to 2001. 27 later devices descend from it.
- Decided
- Aug 5, 2011
- Review
- 193 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K010612 (2001). 18 ancestors in all, the oldest K983831 (1999). 27 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 5 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 4 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 3 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- 2 generations backK060468 Vectorvision HipBrainlab AG · 2006
- 1 generation backK083483 Brainlab Hip Unlimited, CI Hip UnlimitedBrainlab AG · 2009
- This deviceK110204 Brainlab TraumaBrainlab AG · 2011
- Descendant · cites it directly · 13 of its ownK130887 S4C Navigation InstrumentsAesculap Implant System, Inc. · 2013
- Descendant · 2 generations on · 11 of its ownK181890 Brainlab Compatible K2M Navigation InstrumentsK2m · 2018
- Descendant · 3 generations on · 9 of its ownK192911 Brainlab Compatible K2M Navigation InstrumentsK2m, Inc. · 2019
- Descendant · 4 generations on · 8 of its ownK203205 Navigated Spine InstrumentsStryker Spine · 2021
- Descendant · 5 generations on · 7 of its ownK240662 Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments…Stryker Leibinger GmbH & Co KG · 2024
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K130887S4C Navigation InstrumentsAesculap Implant System, Inc. · 2013 · cites it directly13descendants
- K181890Brainlab Compatible K2M Navigation InstrumentsK2m · 2018 · 2 generations on11descendants
- K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc. · 2019 · 3 generations on9descendants
- K203205Navigated Spine InstrumentsStryker Spine · 2021 · 4 generations on8descendants
- K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG · 2024 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −5 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −4 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −3 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| −2 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| −1 | K083483 | Brainlab Hip Unlimited, CI Hip Unlimited | Brainlab AG | 2009 | — |
| 0 (this device) | K110204 | Brainlab Trauma | Brainlab AG | 2011 | — |
| +1 | K130887 | S4C Navigation Instruments | Aesculap Implant System, Inc. | 2013 | — |
| +2 | K181890 | Brainlab Compatible K2M Navigation Instruments | K2m | 2018 | — |
| +3 | K192911 | Brainlab Compatible K2M Navigation Instruments | K2m, Inc. | 2019 | — |
| +4 | K203205 | Navigated Spine Instruments | Stryker Spine | 2021 | — |
| +5 | K240662 | Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q… | Stryker Leibinger GmbH & Co KG | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 6 | 0 |
| 2025 | 4 | 0 |
| 2026 | 7 | 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 OLO? 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? (3)
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 |
|---|---|---|---|
| * | K062358 | Modification to Vectorvision TraumaSummary page 1…ent, Stereotaxic Regulation Number: 21 CFR 882.4560 Product Code: OLO, HAW Predicate Device: Modification to VectorVision Trauma (K062358) VectorVision hip 5.1 unlimited (K083483) Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class 11 Intend… | 2007 |
| * | K042721 | Kolibri SpineSummary page 4…provided by Brainlab in this 510O(k) application was found to be substantially equivalent with the predicate devices Modification to Vector Vsion@ trauma (K062358) and (K042721), Vector Vision hi> 5. 1 unlimited (K083483).… | 2005 |
| * | K083483 | Brainlab Hip Unlimited, CI Hip UnlimitedSummary page 1…21 CFR 882.4560 Product Code: OLO, HAW Predicate Device: Modification to VectorVision Trauma (K062358) VectorVision hip 5.1 unlimited (K083483) Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class 11 Intended Use: Indications For Use: Brainlab t… | 2009 |
What descends from it? (27)
See all 273 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 10 years and passes through 1 company; a new generation was cleared every 1.8 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K130887 (Aesculap Implant System, Inc., 2013) has gone furthest, with 13 descendants of its own.
- 2 other devices also cite its predicate K062358.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 trauma is intended to be a pre- and 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 pre- or intraoperative image data being processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a…
Read the full statement (188 words)
Brainlab trauma is intended to be a pre- and 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 pre- or intraoperative image data being processed by a VectorVision 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, a bone structure like tubular bones, pelvic, calcaneus and talus, scapula, or vertebra, can be identified relative to a CT, fluoroscopic, X-ray or MR based model of the anatomy. In addition to the image guided navigation, Brainlab trauma also enables image-free navigation of trajectories for trauma procedures.
Example procedures include but are not limited to:
* Spinal procedures and spinal implant procedures such as pedicle screw placement.
* Pelvis and acetabular fracture treatment such as screw placement or hlo-sacral screw fixation.
* Fracture treatment procedures such as intramnedullary nailing or plating or screwing, or external fixation procedures in the tubular bones.
* Retrograde drilling of osteochondral lesions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110204: Brainlab Trauma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110204
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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