510(k) · Cleared
Recalled · Class II · 2025xvision Spine system (XVS)
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 19, 2021 as substantially equivalent to K190929 (Augmedics, Ltd., 2019) after a 90-day review. Its family tree reaches back 5 generations to 2005. 2 of the 15 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled once.
- Decided
- Jul 19, 2021
- Review
- 90 days
- Class
- Class II
- Product code
- SBF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K050438 (2005). 6 ancestors in all, the oldest K992927 (1999). 8 later devices descend from it, 1 citing it directly. 2 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 4 generations backK150216 Synergy CranialMedtronic Navigation, Inc. · 2015 · Recalled (Class I)
- 3 generations backK153660 StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · Recalled (Class I)
- 2 generations backK170011 StealthStation S8 Spine Software v1.0.0Medtronic Navigation · 2017
- 1 generation backK190929 xvision Spine system (XVS)Augmedics, Ltd. · 2019
- This deviceK211188 xvision Spine system (XVS)Augmedics, Ltd. · 2021
- Descendant · cites it directly · 7 of its ownK220905 xvision Spine SystemAugmedics, Ltd. · 2022
- Descendant · 2 generations on · 3 of its ownK241481 xvision Spine SystemAugmedics, Ltd. · 2024
- Descendant · 3 generations on · 2 of its ownK250255 xvision Spine systemAugmedics, Ltd. · 2025
- Descendant · 4 generations on · 1 of its ownK251639 xvision Spine systemAugmedics, Ltd. · 2025
- Descendant · 2 generations on · 1 of its ownK231284 OnPoint Augmented Reality Spine SystemOnpoint Surgical, Inc. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K220905xvision Spine SystemAugmedics, Ltd. · 2022 · cites it directly7descendants
- K241481xvision Spine SystemAugmedics, Ltd. · 2024 · 2 generations on3descendants
- K250255xvision Spine systemAugmedics, Ltd. · 2025 · 3 generations on2descendants
- K251639xvision Spine systemAugmedics, Ltd. · 2025 · 4 generations on1descendant
- K231284OnPoint Augmented Reality Spine SystemOnpoint Surgical, Inc. · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | 11 |
| −4 | K150216 | Synergy Cranial | Medtronic Navigation, Inc. | 2015 | Class I |
| −3 | K153660 | StealthStation System with Cranial Software | Medtronic Navigation, Inc. | 2016 | Class I |
| −2 | K170011 | StealthStation S8 Spine Software v1.0.0 | Medtronic Navigation | 2017 | — |
| −1 | K190929 | xvision Spine system (XVS) | Augmedics, Ltd. | 2019 | — |
| 0 (this device) | K211188 | xvision Spine system (XVS) | Augmedics, Ltd. | 2021 | — |
| +1 | K220905 | xvision Spine System | Augmedics, Ltd. | 2022 | — |
| +2 | K241481 | xvision Spine System | Augmedics, Ltd. | 2024 | — |
| +3 | K250255 | xvision Spine system | Augmedics, Ltd. | 2025 | — |
| +4 | K251639 | xvision Spine system | Augmedics, Ltd. | 2025 | — |
| +2 | K231284 | OnPoint Augmented Reality Spine System | Onpoint Surgical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K190929 | xvision Spine system (XVS)Summary page 4…Orthopedic Stereotaxic Instrument (21 CFR 882.4560) Regulatory Class: Class II Product Code: OLO Predicate Devices: xvision Spine, manufactured by Augmedics Ltd. Israel (K190929) Reference Device: VV FLUORO 3D, manufactured by Brainlab AG, Germany (K070106) Intended Use / Indications for Use The xvisio… | 2019 |
| † | K070106 | VV Fluoro 3D | 2007 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220905 | xvision Spine System | 2022 | 7 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 14, 2025 | Class II | Z-1761-2025 | Device Design | The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed. |
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 16 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 4 of the 6 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K220905 (Augmedics, Ltd., 2022) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K190929.
How does its category compare?
All SBF devicesSBF Orthopedic Augmented Reality: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 CT imagery of the anatomy. This can include the spinal…
Read the full statement (169 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 CT imagery of the anatomy. This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
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 as stated in the FDA summary.
https://510kreport.com/device/K211188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211188: xvision Spine system (XVS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211188
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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