510(k) · Cleared
ClearedSpineAR SNAP
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, 2022 as substantially equivalent to K201189 (Medtronic Navigation, Inc., 2020) after a 373-day review. Its family tree reaches back 5 generations to 2005. 2 of the 9 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Sep 29, 2022
- Review
- 373 days
- Class
- Class II
- Product code
- SBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K050438 (2005). 6 ancestors in all, the oldest K992927 (1999). 2 later devices descend from it, 1 citing it directly. 2 of the 9 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 backK201189 Stealthstation S8 Spine Software v1.3.0Medtronic Navigation, Inc. · 2020 · Recalled
- This deviceK213034 SpineAR SNAPSurgical Theater, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK243623 SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc. · 2024 · Recalled
- Descendant · 2 generations on · 0 of its ownK252054 SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc. · 2025
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView 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 | K201189 | Stealthstation S8 Spine Software v1.3.0 | Medtronic Navigation, Inc. | 2020 | 1 |
| 0 (this device) | K213034 | SpineAR SNAP | Surgical Theater, Inc. | 2022 | — |
| +1 | K243623 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | 2024 | 1 |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K201189 | Stealthstation S8 Spine Software v1.3.0Summary page 4…Orthopedic Predicate Device Device Name: StealthStation™ S8 Spine Software v1.3.0 Manufacturer: Medtronic Navigation, Inc. 510(k) Number: K201189 K213034 - Page 1 of 7 510(k) Premarket Notification K213034… | 2020 |
| † | K160584 | Surgical Navigation Advanced Platform (SNAP) | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243623 | SpineAR SNAP (SyncAR Spine) | 2024 | 1 |
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 17 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 5 of the 6 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K243623 (Surgical Theater, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K201189.
How does its category compare?
All SBF devicesSBF Orthopedic Augmented Reality: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 and Magic Leap 1 AR headset displays 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…
Read the full statement (140 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 and Magic Leap 1 AR headset displays 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 Magic Leap 1 AR headset, and in the lumbar region 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 as stated in the FDA summary.
https://510kreport.com/device/K213034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213034: SpineAR SNAP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213034
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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