510(k) · Cleared
ClearedSpine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning
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 13, 2022 as substantially equivalent to K183605 (Brainlab AG, 2019) and 1 other predicate after a 268-day review. Its family tree reaches back 7 generations to 1999. 3 of the 33 devices in its family, counting itself, have a Class I recall. 15 later devices descend from it.
- Decided
- Apr 13, 2022
- Review
- 268 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K983831 (1999). 17 ancestors in all, the oldest K981508 (1998). 15 later devices descend from it, 5 citing it directly. 3 of the 33 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 6 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 5 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 4 generations backK053159 Vectorvision SpineBrainlab AG · 2006 · Recalled
- 3 generations backK070106 VV Fluoro 3DBrainlab AG · 2007 · Recalled (Class I)
- 2 generations backK083310 Spine & Trauma IctBrainlab AG · 2009
- 1 generation backK183605 Spine & Trauma NavigationBrainlab AG · 2019 · Recalled
- This deviceK212245 Spine and Trauma Navigation System, Spine & Trauma 3D Navigation…Brainlab AG · 2022
- Descendant · cites it directly · 6 of its ownK221618 Spine & Trauma Navigation, Spine Navigation, Navigation Software…Brainlab AG · 2022
- Descendant · cites it directly · 5 of its ownK212756 Discectomy Navigation Ready Instruments and Universal Navigation…Medos International SARL · 2022
- Descendant · 2 generations on · 4 of its ownK223108 TELIGEN System Navigation Ready Indications (TELIGEN Access Probe…Medos International SARL · 2023
- Descendant · cites it directly · 2 of its ownK242933 SPINEART Navigation Instrument SystemSpineart SA · 2025
- Descendant · 2 generations on · 2 of its ownK233254 TELIGEN System Navigation Ready InstrumentsDePuy Synthes · 2024
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 15 · See all- K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG · 2022 · cites it directly6descendants
- K212756Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL · 2022 · cites it directly5descendants
- K223108TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)Medos International SARL · 2023 · 2 generations on4descendants
- K242933SPINEART Navigation Instrument SystemSpineart SA · 2025 · cites it directly2descendants
- K233254TELIGEN System Navigation Ready InstrumentsDePuy Synthes · 2024 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −6 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −5 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −4 | K053159 | Vectorvision Spine | Brainlab AG | 2006 | 1 |
| −3 | K070106 | VV Fluoro 3D | Brainlab AG | 2007 | Class I |
| −2 | K083310 | Spine & Trauma Ict | Brainlab AG | 2009 | — |
| −1 | K183605 | Spine & Trauma Navigation | Brainlab AG | 2019 | 3 |
| 0 (this device) | K212245 | Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument… | Brainlab AG | 2022 | — |
| +1 | K221618 | Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine &… | Brainlab AG | 2022 | — |
| +1 | K212756 | Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set | Medos International SARL | 2022 | — |
| +2 | K223108 | TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN… | Medos International SARL | 2023 | — |
| +1 | K242933 | SPINEART Navigation Instrument System | Spineart SA | 2025 | — |
| +2 | K233254 | TELIGEN System Navigation Ready Instruments | DePuy Synthes | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 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? (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 |
|---|---|---|---|
| * | K183605 | Spine & Trauma NavigationSummary page 4…er 882.4560 Regulatory Class II Panel Orthopedic Predicate Devices Primary: Spine & Trauma Navigation K183605 Secondary: : Medtronic StealthStation S8 Spine Software v1.0.0; K1… | 2019 |
| * | K170011 | StealthStation S8 Spine Software v1.0.0Summary page 4…Primary: Spine & Trauma Navigation K183605 Secondary: : Medtronic StealthStation S8 Spine Software v1.0.0; K170011 Contact Information Primary Contact Alt… | 2017 |
What descends from it? (15)
See all 155 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221618 | Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma… | 2022 | 6 |
| K212756 | Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set | 2022 | 5 |
| K242933 | SPINEART Navigation Instrument System | 2025 | 2 |
| K254158 | SPINEART Navigation Instrument System | 2026 | 1 |
| K223553 | Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine | 2023 | 1 |
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.
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 2 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 3 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K070106VV Fluoro 3DBrainlab AG · 2007 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 1 company; a new generation was cleared every 2.6 years on median.
- 8 of the 17 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K221618 (Brainlab AG, 2022) has gone furthest, with 6 descendants of its own.
- 5 other devices also cite its predicate K183605.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable open and 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 2D or 3D image data. Spine & Trauma Navigation System enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or…
Read the full statement (185 words)
Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable open and 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 2D or 3D image data.
Spine & Trauma Navigation System 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 and interbody device planning and navigation with surgical instruments.
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 image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
Spine Planning is intended for pre- and intraoperative planning of open- and minimal invasive spinal procedures. It displays digital bio imaging and allows measurement and planning of spinal implants like screws and rods.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212245: Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212245
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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