510(k) · Cleared
Recalled · Class II · 2020Spine & Trauma Navigation
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 29, 2019 as substantially equivalent to K083310 (Brainlab AG, 2009) after a 246-day review. Its family tree reaches back 6 generations to 1999. 1 of the 37 devices in its family, counting itself, has a Class I recall. 25 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 29, 2019
- Review
- 246 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 6 generations to K983831 (1999). 11 ancestors in all, the oldest K981508 (1998). 25 later devices descend from it, 6 citing it directly. 1 of the 37 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 5 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 4 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 3 generations backK053159 Vectorvision SpineBrainlab AG · 2006 · Recalled
- 2 generations backK070106 VV Fluoro 3DBrainlab AG · 2007 · Recalled (Class I)
- 1 generation backK083310 Spine & Trauma IctBrainlab AG · 2009
- This deviceK183605 Spine & Trauma NavigationBrainlab AG · 2019
- Descendant · cites it directly · 15 of its ownK212245 Spine and Trauma Navigation System, Spine & Trauma 3D Navigation…Brainlab AG · 2022
- Descendant · cites it directly · 9 of its ownK202320 CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module…Brainlab AG · 2020
- Descendant · cites it directly · 7 of its ownK201661 Symphony Navigation Ready Instruments and Universal Navigation…Medos International SARL · 2020
- Descendant · 2 generations on · 6 of its ownK221618 Spine & Trauma Navigation, Spine Navigation, Navigation Software…Brainlab AG · 2022
- Descendant · 2 generations on · 5 of its ownK212756 Discectomy Navigation Ready Instruments and Universal Navigation…Medos International SARL · 2022
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K070106 VV Fluoro 3D2 generations back · 2007
Most influential descendants
Showing 5 of 25 · See all- K212245Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection…Brainlab AG · 2022 · cites it directly15descendants
- K202320CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic…Brainlab AG · 2020 · cites it directly9descendants
- K201661Symphony Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL · 2020 · cites it directly7descendants
- K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG · 2022 · 2 generations on6descendants
- K212756Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL · 2022 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −5 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −4 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −3 | K053159 | Vectorvision Spine | Brainlab AG | 2006 | 1 |
| −2 | K070106 | VV Fluoro 3D | Brainlab AG | 2007 | Class I |
| −1 | K083310 | Spine & Trauma Ict | Brainlab AG | 2009 | — |
| 0 (this device) | K183605 | Spine & Trauma Navigation | Brainlab AG | 2019 | — |
| +1 | K212245 | Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument… | Brainlab AG | 2022 | — |
| +1 | K202320 | CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal… | Brainlab AG | 2020 | — |
| +1 | K201661 | Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set | Medos International SARL | 2020 | — |
| +2 | K221618 | Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine &… | Brainlab AG | 2022 | — |
| +2 | K212756 | Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set | Medos International SARL | 2022 | — |
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 |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K083310 | Spine & Trauma IctSummary page 4….4560 Review Panel Orthopedic Product Code: OLO Device Class: Class II Predicate Device: K083310, Spine and Trauma iCT Date of preparation December 20, 2018 Contact Infor… | 2009 |
What descends from it? (25)
See all 256 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212245 | Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection… | 2022 | 15 |
| K202320 | CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic… | 2020 | 9 |
| K201661 | Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set | 2020 | 7 |
| K203679 | Automatic Registration | 2021 | 1 |
| K242271 | Caduceus S | 2024 | 0 |
| K220554 | Caduceus S | 2022 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 20, 2020 | Class II | Z-2925-2020 | Component design/selection | Holding force of the Positioning Arm can be reduced by prolonged non-use. |
| Jul 16, 2020 | Class II | Z-2793-2020 | Process control | Incorrect manufacturer calibration |
| Jul 16, 2020 | Class II | Z-2792-2020 | Process control | Incorrect manufacturer calibration |
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 back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 1 company; a new generation was cleared every 2.8 years on median.
- 3 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K212245 (Brainlab AG, 2022) has gone furthest, with 15 descendants of its own.
- 2 other devices also cite its predicate K083310.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 3D 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 2D or 3D image data. Spine & Trauma 3D enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image…
Read the full statement (155 words)
Spine & Trauma 3D 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 2D or 3D image data.
Spine & Trauma 3D 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 image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183605 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183605: Spine & Trauma Navigation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183605
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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