510(k) · Cleared
ClearedSpineAR SNAP (SyncAR Spine)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Theater, Inc. · SBF Orthopedic Augmented Reality
Cleared on Sep 29, 2025 as substantially equivalent to K243623 (Surgical Theater, Inc., 2024) after a 90-day review. Its family tree reaches back 7 generations to 2005. 2 of the 9 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 29, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- SBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K050438 (2005). 8 ancestors in all, the oldest K992927 (1999). No later device cites it as a predicate yet. 2 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 6 generations backK150216 Synergy CranialMedtronic Navigation, Inc. · 2015 · Recalled (Class I)
- 5 generations backK153660 StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · Recalled (Class I)
- 4 generations backK170011 StealthStation S8 Spine Software v1.0.0Medtronic Navigation · 2017
- 3 generations backK201189 Stealthstation S8 Spine Software v1.3.0Medtronic Navigation, Inc. · 2020 · Recalled
- 2 generations backK213034 SpineAR SNAPSurgical Theater, Inc. · 2022
- 1 generation backK243623 SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc. · 2024 · Recalled
- This deviceK252054 SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc. · 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 |
|---|---|---|---|---|---|
| −7 | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | 11 |
| −6 | K150216 | Synergy Cranial | Medtronic Navigation, Inc. | 2015 | Class I |
| −5 | K153660 | StealthStation System with Cranial Software | Medtronic Navigation, Inc. | 2016 | Class I |
| −4 | K170011 | StealthStation S8 Spine Software v1.0.0 | Medtronic Navigation | 2017 | — |
| −3 | K201189 | Stealthstation S8 Spine Software v1.3.0 | Medtronic Navigation, Inc. | 2020 | 1 |
| −2 | K213034 | SpineAR SNAP | Surgical Theater, Inc. | 2022 | — |
| −1 | K243623 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | 2024 | 1 |
| 0 (this device) | K252054 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K243623 | SpineAR SNAP (SyncAR Spine)Summary page 5…• Device Panel: Orthopedic Predicate Device Device Name: SpineAR SNAP Manufacturer: Surgical Theater, Inc. 510(k) Number: K243623 K252054 - 510(k) Summary Page 1 of 9 510(k)… | 2024 |
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 20 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 8 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. 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?
SpineAR SNAP is intended for use for pre-operative surgical planning on-screen and in a virtual environment, and intra-operative surgical planning and visualization on-screen and in an augmented environment using the HoloLens2 AR headset display with validated navigation systems as identified in the device labeling. SpineAR SNAP is indicated for spinal stereotaxic surgery, and where reference to a rigid anatomical structure, such as the spine, can be…
Read the full statement (124 words)
SpineAR SNAP is intended for use for pre-operative surgical planning on-screen and in a virtual environment, and intra-operative surgical planning and visualization on-screen and in an augmented environment using the HoloLens2 AR headset display with validated navigation systems as identified in the device labeling.
SpineAR SNAP is indicated for spinal stereotaxic surgery, and where reference to a rigid anatomical structure, such as the spine, can be identified relative to images of the anatomy. SpineAR is intended for use in spinal implant procedures, such as Pedicle Screw Placement, in the lumbar and thoracic regions with the HoloLens2 AR headset.
The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed 2D 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/K252054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252054: SpineAR SNAP (SyncAR Spine).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252054
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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