510(k) · Cleared
Recalled · Class II · 2024TrackX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Track X Technology, LLC · OWB Interventional Fluoroscopic X-Ray System
Cleared on Mar 5, 2020 as substantially equivalent to K173736 (Track X Technology, LLC, 2018) after a 21-day review. Its family tree reaches back 6 generations to 2002. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 5, 2020
- Review
- 21 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 6 generations to K013841 (2002). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK013841 3DFIS, Model Ies-FL-1013Dsharp, Inc. · 2002
- 5 generations backK123226 LessraySaferay Spine, LLC · 2012
- 4 generations backK132970 LessraySaferay Spine, LLC · 2013
- 3 generations backK142243 LessRay with TrackingSaferay Spine, LLC · 2014
- 2 generations backK170800 NuVasive LessRay with Enhanced TrackingNu Vasive, Incorporated · 2017
- 1 generation backK173736 TrackXTrack X Technology, LLC · 2018 · Recalled
- This deviceK200360 TrackXTrack X Technology, LLC · 2020
- Descendant · cites it directly · 0 of its ownK251992 ArmSure Fluoroscopic Positioning SystemSavfe Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK213768 Bolt Navigation SystemCircinus Medical Technology, LLC · 2022
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 |
|---|---|---|---|---|---|
| −6 | K013841 | 3DFIS, Model Ies-FL-101 | 3Dsharp, Inc. | 2002 | — |
| −5 | K123226 | Lessray | Saferay Spine, LLC | 2012 | — |
| −4 | K132970 | Lessray | Saferay Spine, LLC | 2013 | — |
| −3 | K142243 | LessRay with Tracking | Saferay Spine, LLC | 2014 | — |
| −2 | K170800 | NuVasive LessRay with Enhanced Tracking | Nu Vasive, Incorporated | 2017 | — |
| −1 | K173736 | TrackX | Track X Technology, LLC | 2018 | 2 |
| 0 (this device) | K200360 | TrackX | Track X Technology, LLC | 2020 | — |
| +1 | K251992 | ArmSure Fluoroscopic Positioning System | Savfe Co., Ltd. | 2026 | — |
| +1 | K213768 | Bolt Navigation System | Circinus Medical Technology, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 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.
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 |
|---|---|---|---|
| * | K173736 | TrackXSummary page 5…Track X Technology, LLC Page 1 510(k) Number: K173736 Regulation Name: Image-intensified fluoroscopic x-ray system 21 CFR… | 2018 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 3, 2024 | Class III | Z-0260-2025 | Error in labeling | The patient label stickers may have the wrong expiration date recorded. The contract manufacturer entered the manufacturing date (2024-04-01) as the expiration date. The actual expiration date of the product is 2027-04-01. This is… |
| Oct 24, 2022 | Class II | Z-1107-2023 | Device Design | The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K251992 (Savfe Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K173736.
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. 2020, 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?
TrackX v.2.0 is intended for use in any application where a fluoroscope is incorporated to aid in the diagnosis and
treatment of disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200360 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200360: TrackX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200360
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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