510(k) · Cleared
ClearedSpine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab SE · OLO Orthopedic Stereotaxic Instrument
Cleared on Sep 30, 2026 as substantially equivalent to K223553 (Brainlab AG, 2023) and 1 other predicate after a 90-day review. Its family tree reaches back 9 generations to 1999. 3 of the 35 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 30, 2026
- Review
- 90 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K983831 (1999). 34 ancestors in all, the oldest K981508 (1998). No later device cites it as a predicate yet. 3 of the 35 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 5 generations between
- 3 generations backK183605 Spine & Trauma NavigationBrainlab AG · 2019 · Recalled
- 2 generations backK202320 CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module…Brainlab AG · 2020
- 1 generation backK221618 Spine & Trauma Navigation, Spine Navigation, Navigation Software…Brainlab AG · 2022
- This deviceK262257 Spine Planning (3.0); Spine & Trauma Navigation; Alignment System…Brainlab SE · 2026
Show all 9 generations
- Root · 9 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 8 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 7 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 6 generations backK053159 Vectorvision SpineBrainlab AG · 2006 · Recalled
- 5 generations backK070106 VV Fluoro 3DBrainlab AG · 2007 · Recalled (Class I)
- 4 generations backK083310 Spine & Trauma IctBrainlab AG · 2009
- 3 generations backK183605 Spine & Trauma NavigationBrainlab AG · 2019 · Recalled
- 2 generations backK202320 CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module…Brainlab AG · 2020
- 1 generation backK221618 Spine & Trauma Navigation, Spine Navigation, Navigation Software…Brainlab AG · 2022
- This deviceK262257 Spine Planning (3.0); Spine & Trauma Navigation; Alignment System…Brainlab SE · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −8 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −7 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −6 | K053159 | Vectorvision Spine | Brainlab AG | 2006 | 1 |
| −5 | K070106 | VV Fluoro 3D | Brainlab AG | 2007 | Class I |
| −4 | K083310 | Spine & Trauma Ict | Brainlab AG | 2009 | — |
| −3 | K183605 | Spine & Trauma Navigation | Brainlab AG | 2019 | 3 |
| −2 | K202320 | CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal… | Brainlab AG | 2020 | — |
| −1 | K221618 | Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine &… | Brainlab AG | 2022 | — |
| 0 (this device) | K262257 | Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine | Brainlab SE | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K223553 | Spine Planning (2.0), Elements Spine Planning, Elements Planning SpineSummary page 5…OLO Regulation Number 882.4560 Regulatory Class II Panel Orthopedic Predicate Device(s) K223553 – Spine Planning K221618 - Spine & Trauma Navigation, Spine Navigation,… | 2023 |
| * | K221618 | Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Summary page 5…Regulatory Class II Panel Orthopedic Predicate Device(s) K223553 – Spine Planning K221618 - Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment Sys… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 4 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 5 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K070106VV Fluoro 3DBrainlab AG · 2007 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 9 of the 34 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Planning: Spine Planning is intended for pre- and intraoperative planning of open and minimally invasive spinal procedures. It displays digital patient images (CT, Cone Beam CT, MR, X-ray) and allows measurement and planning of spinal implants like screws and rods. The device is indicated for adult patients. Spine & Trauma Navigation: Spine & Trauma Navigation is intended as an intraoperative image-guided localization system to enable open and…
Read the full statement (243 words)
Spine Planning:
Spine Planning is intended for pre- and intraoperative planning of open and minimally invasive spinal procedures. It displays digital patient images (CT, Cone Beam CT, MR, X-ray) and allows measurement and planning of spinal implants like screws and rods. The device is indicated for adult patients.
Spine & Trauma Navigation:
Spine & Trauma Navigation 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 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, 3D fluoroscopic image reconstruction or 2D fluoroscopic image) and/or an image databased model of the anatomy.
Alignment System Spine:
As an accessory to the Spine & Trauma Navigation, the Alignment System Spine is intended to support the surgeon to achieve a pre-defined screw with surgical instruments during the surgical procedure. It is used for spinal screw placement procedures.
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/K262257 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262257: Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262257
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026