510(k) · Cleared
ClearedArmSure Fluoroscopic Positioning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Savfe Co., Ltd. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Feb 11, 2026 as substantially equivalent to K173736 (Track X Technology, LLC, 2018) and 1 other predicate after a 229-day review. Its family tree reaches back 7 generations to 2002.
- Decided
- Feb 11, 2026
- Review
- 229 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 2
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 deviceK251992 ArmSure Fluoroscopic Positioning SystemSavfe Co., Ltd. · 2026
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) | K251992 | ArmSure Fluoroscopic Positioning System | Savfe Co., Ltd. | 2026 | — |
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 18.2 · 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? (2)
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…TrackX v.2.0 Manufacturer Track X Technology, LLC Track X Technology, LLC 510(k) Number K173736 K200360 Regulation Number 892.1650 892.165… | 2018 |
| * | K200360 | TrackXSummary page 5…Track X Technology, LLC Track X Technology, LLC 510(k) Number K173736 K200360 Regulation Number 892.1650 892.1650 Product Code… | 2020 |
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 24 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 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. 2026, 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 ArmSure Fluoroscopic Positioning System is a software-enabled manual Assist Arm intended for use with fluoroscopic systems to assist in the visualization of the spatial relationship of attached compatible surgical instruments and interventional accessories on X-ray images, and to maintain the corresponding spatial position to hold the attached instrument or accessory.
The ArmSure system is intended to be used by trained healthcare professionals in a clinical environment, and is indicated for use during fluoroscopically-guided procedures involving the spine and long bones in patients whose anatomical size is suitable for the compatible instruments and the host fluoroscopic system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251992: ArmSure Fluoroscopic Positioning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251992
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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