510(k) · Cleared
Clearedxvision Spine system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Augmedics, Ltd. · SBF Orthopedic Augmented Reality
Cleared on Jul 31, 2026 as substantially equivalent to K251639 (Augmedics, Ltd., 2025) after a 58-day review. Its family tree reaches back 10 generations to 2005. 2 of the 12 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 31, 2026
- Review
- 58 days
- Class
- Class II
- Product code
- SBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K050438 (2005). 11 ancestors in all, the oldest K992927 (1999). No later device cites it as a predicate yet. 2 of the 12 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 6 generations between
- 3 generations backK241481 xvision Spine SystemAugmedics, Ltd. · 2024
- 2 generations backK250255 xvision Spine systemAugmedics, Ltd. · 2025
- 1 generation backK251639 xvision Spine systemAugmedics, Ltd. · 2025
- This deviceK261854 xvision Spine systemAugmedics, Ltd. · 2026
Show all 10 generations
- Root · 10 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 9 generations backK150216 Synergy CranialMedtronic Navigation, Inc. · 2015 · Recalled (Class I)
- 8 generations backK153660 StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · Recalled (Class I)
- 7 generations backK170011 StealthStation S8 Spine Software v1.0.0Medtronic Navigation · 2017
- 6 generations backK190929 xvision Spine system (XVS)Augmedics, Ltd. · 2019
- 5 generations backK211188 xvision Spine system (XVS)Augmedics, Ltd. · 2021 · Recalled
- 4 generations backK220905 xvision Spine SystemAugmedics, Ltd. · 2022
- 3 generations backK241481 xvision Spine SystemAugmedics, Ltd. · 2024
- 2 generations backK250255 xvision Spine systemAugmedics, Ltd. · 2025
- 1 generation backK251639 xvision Spine systemAugmedics, Ltd. · 2025
- This deviceK261854 xvision Spine systemAugmedics, Ltd. · 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 |
|---|---|---|---|---|---|
| −10 | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | 11 |
| −9 | K150216 | Synergy Cranial | Medtronic Navigation, Inc. | 2015 | Class I |
| −8 | K153660 | StealthStation System with Cranial Software | Medtronic Navigation, Inc. | 2016 | Class I |
| −7 | K170011 | StealthStation S8 Spine Software v1.0.0 | Medtronic Navigation | 2017 | — |
| −6 | K190929 | xvision Spine system (XVS) | Augmedics, Ltd. | 2019 | — |
| −5 | K211188 | xvision Spine system (XVS) | Augmedics, Ltd. | 2021 | 1 |
| −4 | K220905 | xvision Spine System | Augmedics, Ltd. | 2022 | — |
| −3 | K241481 | xvision Spine System | Augmedics, Ltd. | 2024 | — |
| −2 | K250255 | xvision Spine system | Augmedics, Ltd. | 2025 | — |
| −1 | K251639 | xvision Spine system | Augmedics, Ltd. | 2025 | — |
| 0 (this device) | K261854 | xvision Spine system | Augmedics, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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.
2 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 |
|---|---|---|---|
| * | K251639 | xvision Spine systemSummary page 5…ass II Product Code: SBF Predicate Device: xvision Spine System, manufactured by Augmedics Ltd. (K251639) INTENDED USE / INDICATIONS FOR USE The xvision Spine system, with xvision Spine system software, is intended as an aid for pre… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 11 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All SBF devicesSBF Orthopedic Augmented Reality: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
The xvision Spine System, with xvision Spine System Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to a patient’s fluoroscopic or CT imagery of the anatomy.…
Read the full statement (196 words)
The xvision Spine System, with xvision Spine System Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures.
Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to a patient’s fluoroscopic or CT imagery of the anatomy. This can include the following spinal procedures:
Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
Posterior Screw Placement in C3-C7 vertebrae
Iliosacral Screw Placement
Angular procedures requiring access to the disc space
Lateral trajectories required to access the Sacro-Iliac joint
The Headset of the xvision Spine System displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261854: xvision Spine system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261854
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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