510(k) · Cleared
ClearedMixed Reality Spine Navigation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · SBF Orthopedic Augmented Reality
Cleared on May 16, 2025 as substantially equivalent to K221618 (Brainlab AG, 2022) after a 261-day review. Its family tree reaches back 9 generations to 1999. 3 of the 34 devices in its family, counting itself, have a Class I recall.
- Decided
- May 16, 2025
- Review
- 261 days
- Class
- Class II
- Product code
- SBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K983831 (1999). 33 ancestors in all, the oldest K981508 (1998). No later device cites it as a predicate yet. 3 of the 34 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 deviceK242569 Mixed Reality Spine NavigationBrainlab AG · 2025
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 deviceK242569 Mixed Reality Spine NavigationBrainlab AG · 2025
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) | K242569 | Mixed Reality Spine Navigation | Brainlab AG | 2025 | — |
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 |
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 SBF device
- #1 K193559 NextAR TKA Platformscore 20.3 · 10 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 |
|---|---|---|---|
| * | K221618 | Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Summary page 5…SBF Regulation Number 882.4560 Regulatory Class II Panel Orthopedic Predicate Device K221618 - Spine & Trauma Navigation Reference Device K223290, CommandEP Data Manager PC (DPC02),… | 2022 |
| † | K223290 | CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) | 2023 |
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 26 years and passes through 1 company; a new generation was cleared every 1.9 years on median.
- 9 of the 33 ancestors have a recall of any class; 3 have a Class I recall.
- 4 other devices also cite its predicate K221618.
How does its category compare?
All SBF devicesSBF Orthopedic Augmented Reality: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SBF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SBF
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · SBF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · SBF
1in 2025
MAUDE reports naming product code SBF, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 4 | 162 | 0 | 0 |
| 2022 | 7 | 234 | 0 | 0 |
| 2023 | 7 | 104 | 0 | 0 |
| 2024 | 6 | 89 | 0 | 0 |
| 2025 | 13 | 90 | 1 | 1 |
| 2026 | 3 | 123 | 1 | — |
What is it indicated for?
Mixed Reality Spine Navigation is an accessory to the Spine & Trauma Navigation Medical Device. The software is intended to display 2D navigation screens as well as a floating 3D virtual representation and stereotaxic information of tracked instruments on a virtual display using a Mixed Reality headset. The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242569 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242569: Mixed Reality Spine Navigation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242569
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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