510(k) · Cleared
ClearedARAI Surgical Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgalign Spine Technologies · SBF Orthopedic Augmented Reality
Cleared on Jan 14, 2022 as substantially equivalent to K170011 (Medtronic Navigation, 2017) after a 263-day review. Its family tree reaches back 4 generations to 2005. 2 of the 7 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jan 14, 2022
- Review
- 263 days
- Class
- Class II
- Product code
- SBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K050438 (2005). 5 ancestors in all, the oldest K992927 (1999). 1 later device descends from it, 1 citing it directly. 2 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 3 generations backK150216 Synergy CranialMedtronic Navigation, Inc. · 2015 · Recalled (Class I)
- 2 generations backK153660 StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · Recalled (Class I)
- 1 generation backK170011 StealthStation S8 Spine Software v1.0.0Medtronic Navigation · 2017
- This deviceK211254 ARAI Surgical Navigation SystemSurgalign Spine Technologies · 2022
- Descendant · cites it directly · 0 of its ownK231611 HOLO Portal™ Surgical Guidance SystemSurgalign Spine Technologies · 2023
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K231611HOLO Portal™ Surgical Guidance SystemSurgalign Spine Technologies · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | 11 |
| −3 | K150216 | Synergy Cranial | Medtronic Navigation, Inc. | 2015 | Class I |
| −2 | K153660 | StealthStation System with Cranial Software | Medtronic Navigation, Inc. | 2016 | Class I |
| −1 | K170011 | StealthStation S8 Spine Software v1.0.0 | Medtronic Navigation | 2017 | — |
| 0 (this device) | K211254 | ARAI Surgical Navigation System | Surgalign Spine Technologies | 2022 | — |
| +1 | K231611 | HOLO Portal™ Surgical Guidance System | Surgalign Spine Technologies | 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 |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K170011 | StealthStation S8 Spine Software v1.0.0Summary page 4…82.4560, 892.2050 Product Code(s): OLO, LLZ Class II Primary Predicate: StealthStation S8 Spine Software V1.0.0 (K170011) Reference Devices(s): OpenSight (K172418) xvision Spine (K190929) Streamline Na… | 2017 |
| † | K172418 | OpenSight | 2018 |
| † | K190929 | xvision Spine system (XVS) | 2019 |
| † | K200095 | Streamline Navigated Instruments | 2020 |
| † | K192800 | Streamline TL Spinal Fixation System | 2020 |
| † | K192396 | Streamline MIS Spinal Fixation System | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231611 | HOLO Portal™ Surgical Guidance System | 2023 | 0 |
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 4.7 years on median.
- 4 of the 5 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K231611 (Surgalign Spine Technologies, 2023) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K170011.
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?
The ARAI™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures in the lumbosacral spine region. Their use is indicated for any medical condition of the lumbosacral spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the iliac crest, can be identified relative to intraoperative CT images of the anatomy. The…
Read the full statement (155 words)
The ARAI™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures in the lumbosacral spine region. Their use is indicated for any medical condition of the lumbosacral spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the iliac crest, can be identified relative to intraoperative CT images of the anatomy.
The ARAI System simultaneously displays 2D stereotaxic data along with a 3D virtual anatomy model over the patient during surgery. The stereotaxic display is indicated for continuously tracking instrument position and orientation to the registered patient anatomy while the 3D display is indicated for localizing the virtual instrument to the virtual anatomy model over the patient during surgery. The 3D 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/K211254 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211254: ARAI Surgical Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211254
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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