510(k) · Cleared
ClearedBolt Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Circinus Medical Technology, LLC · OWB Interventional Fluoroscopic X-Ray System
Cleared on Dec 1, 2022 as substantially equivalent to K200360 (Track X Technology, LLC, 2020) after a 365-day review. Its family tree reaches back 7 generations to 2002.
- Decided
- Dec 1, 2022
- Review
- 365 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K013841 (2002). No later device cites it as a predicate yet.
- Root · 7 generations backK013841 3DFIS, Model Ies-FL-1013Dsharp, Inc. · 2002
- 6 generations backK123226 LessraySaferay Spine, LLC · 2012
- 5 generations backK132970 LessraySaferay Spine, LLC · 2013
- 4 generations backK142243 LessRay with TrackingSaferay Spine, LLC · 2014
- 3 generations backK170800 NuVasive LessRay with Enhanced TrackingNu Vasive, Incorporated · 2017
- 2 generations backK173736 TrackXTrack X Technology, LLC · 2018 · Recalled
- 1 generation backK200360 TrackXTrack X Technology, LLC · 2020 · Recalled
- This deviceK213768 Bolt Navigation SystemCircinus Medical Technology, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K013841 | 3DFIS, Model Ies-FL-101 | 3Dsharp, Inc. | 2002 | — |
| −6 | K123226 | Lessray | Saferay Spine, LLC | 2012 | — |
| −5 | K132970 | Lessray | Saferay Spine, LLC | 2013 | — |
| −4 | K142243 | LessRay with Tracking | Saferay Spine, LLC | 2014 | — |
| −3 | K170800 | NuVasive LessRay with Enhanced Tracking | Nu Vasive, Incorporated | 2017 | — |
| −2 | K173736 | TrackX | Track X Technology, LLC | 2018 | 2 |
| −1 | K200360 | TrackX | Track X Technology, LLC | 2020 | 2 |
| 0 (this device) | K213768 | Bolt Navigation System | Circinus Medical Technology, LLC | 2022 | — |
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.
Planning a device in OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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 |
|---|---|---|---|
| * | K200360 | TrackXSummary page 5…gid structures can be identified relative to a perioperative image data of the anatomy and the gravity vector. Predicate Device: The Track X Technology, TrackX Device (K200360) serves as the primary predicate device. The Augmedics xvision Spine System (K190929) and the Medtronic StealthStation (K133444,… | 2020 |
| † | K190929 | xvision Spine system (XVS) | 2019 |
| † | K133444 | Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System | 2014 |
| † | K170011 | StealthStation S8 Spine Software v1.0.0 | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K200360.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The Bolt Navigation System assists in the accurate placement of pedicle screws when used in conjunction with an intraoperative fluoroscope. It utilizes intraoperative fluoroscopic and pre- operative MRI or CT axial images to provide surgical planning and navigational telemetry relative to gravity, based on a fixed entry point ascertained by the user and validated by intraoperative fluoroscopic imaging. It is not intended to track patient position. The…
Read the full statement (105 words)
The Bolt Navigation System assists in the accurate placement of pedicle screws when used in conjunction with an intraoperative fluoroscope. It utilizes intraoperative fluoroscopic and pre- operative MRI or CT axial images to provide surgical planning and navigational telemetry relative to gravity, based on a fixed entry point ascertained by the user and validated by intraoperative fluoroscopic imaging. It is not intended to track patient position. The System is indicated for open and minimally invasive pedicle screw placement using a posterior approach in the thoracolumbar and sacral spine (T-9 to S1) where the patients’ relevant rigid anatomical structures can be clearly identified on the imaging.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213768 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213768: Bolt 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/K213768
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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