510(k) · Cleared
Recalled · Class II · 2017Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular, Inc. · OTD Endovascular Suturing System
Cleared on Jun 13, 2017 as substantially equivalent to DEN100026 (Aptus Endosystems, Inc., 2011) and 5 other predicates after a 29-day review. Its family tree reaches back 5 generations to 2011. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 13, 2017
- Review
- 29 days
- Class
- Class II
- Product code
- OTD
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 5 generations to DEN100026 (2011). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backDEN100026 Aptus Steerable Endoguide with Obturator, Aptus Endostaple Applier…Aptus Endosystems, Inc. · 2011
- 4 generations backK121168 Aptus 18FR Helifx Guide-22 Deflectable LengthAptus Endosystems, Inc. · 2012
- 3 generations backK130677 Aptus Heli-FX Aortic Securement SystemAptus Endosystems, Inc. · 2013
- 2 generations backK140036 Aptus Heli-FX Guide - 22CM Deflectable Length; Aptus Heli-FX Guide -…Aptus Endosystems, Inc. · 2014
- 1 generation backK141041 Aptus Heli-FX Ancillary Endoanchor CassetteAptus Endosystems · 2014
- This deviceK171427 Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteMedtronic Vascular, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK182957 Heli-FX EndoAnchor SystemMedtronic Vascular, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K182957Heli-FX EndoAnchor SystemMedtronic Vascular, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN100026 | Aptus Steerable Endoguide with Obturator, Aptus Endostaple Applier with… | Aptus Endosystems, Inc. | 2011 | — |
| −4 | K121168 | Aptus 18FR Helifx Guide-22 Deflectable Length | Aptus Endosystems, Inc. | 2012 | — |
| −3 | K130677 | Aptus Heli-FX Aortic Securement System | Aptus Endosystems, Inc. | 2013 | — |
| −2 | K140036 | Aptus Heli-FX Guide - 22CM Deflectable Length; Aptus Heli-FX Guide - 28CM… | Aptus Endosystems, Inc. | 2014 | — |
| −1 | K141041 | Aptus Heli-FX Ancillary Endoanchor Cassette | Aptus Endosystems | 2014 | — |
| 0 (this device) | K171427 | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette | Medtronic Vascular, Inc. | 2017 | — |
| +1 | K182957 | Heli-FX EndoAnchor System | Medtronic Vascular, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 OTD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | DEN100026 | Aptus Steerable Endoguide with Obturator, Aptus Endostaple Applier with Endostaple…Summary page 5…• Heli-FX Guide • Ancillary EndoAnchor Cassette containing five EndoAnchor implants Predicate Devices • Aptus Heli-FX EndoAnchor System per DEN100026 (K102333) • Aptus Heli-FX Thoracic EndoAnchor System per K121168 • Aptus Heli-FX EndoAnchor System and Heli-FX Thoracic… | 2011 |
| * | DEN100026 | Aptus Steerable Endoguide with Obturator, Aptus Endostaple Applier with Endostaple… Our reading of the summary gave K102333, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN100026, Aptus Steerable Endoguide with Obturator, Aptus Endostaple… (Aptus Endosystems, Inc.), granted Nov 21, 2011; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2011 |
| * | K121168 | Aptus 18FR Helifx Guide-22 Deflectable LengthSummary page 5…EndoAnchor implants Predicate Devices • Aptus Heli-FX EndoAnchor System per DEN100026 (K102333) • Aptus Heli-FX Thoracic EndoAnchor System per K121168 • Aptus Heli-FX EndoAnchor System and Heli-FX Thoracic EndoAnchor System per K130677 • Aptus Heli-FX EndoAnchor… | 2012 |
| * | K130677 | Aptus Heli-FX Aortic Securement SystemSummary page 5…DEN100026 (K102333) • Aptus Heli-FX Thoracic EndoAnchor System per K121168 • Aptus Heli-FX EndoAnchor System and Heli-FX Thoracic EndoAnchor System per K130677 • Aptus Heli-FX EndoAnchor System per K140036 • Aptus Heli-FX EndoAnchor Ancillary Cassette per K141041 Intended Use T… | 2013 |
| * | K140036 | Aptus Heli-FX Guide - 22CM Deflectable Length; Aptus Heli-FX Guide - 28CM Deflectable…Summary page 5…EndoAnchor System per K121168 • Aptus Heli-FX EndoAnchor System and Heli-FX Thoracic EndoAnchor System per K130677 • Aptus Heli-FX EndoAnchor System per K140036 • Aptus Heli-FX EndoAnchor Ancillary Cassette per K141041 Intended Use The Heli-FX EndoAnchor System is intended to provide… | 2014 |
| * | K141041 | Aptus Heli-FX Ancillary Endoanchor CassetteSummary page 5…ystem and Heli-FX Thoracic EndoAnchor System per K130677 • Aptus Heli-FX EndoAnchor System per K140036 • Aptus Heli-FX EndoAnchor Ancillary Cassette per K141041 Intended Use The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and th… | 2014 |
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 |
|---|---|---|---|
| K182957 | Heli-FX EndoAnchor System | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 13, 2017 | Class II | Z-3227-2017 | Labeling Change Control | It was determined that the deflection length indicated on the Guide catheter handle does not match the label on the box and sterile packaging for two lots. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K182957 (Medtronic Vascular, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate DEN100026.
How does its category compare?
All OTD devicesOTD Endovascular Suturing System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OTD
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · OTD
Too few OTD 510(k)s in any year since 2007 to give a median.
Recalls per year · OTD
No recall names OTD since 2007.
Adverse event reports per year · OTD
53in 2025
MAUDE reports naming product code OTD, 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 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 5 |
| 2014 | 2 | — | 0 | 16 |
| 2015 | 0 | — | 0 | 72 |
| 2016 | 0 | — | 0 | 166 |
| 2017 | 1 | — | 0 | 161 |
| 2018 | 1 | — | 0 | 215 |
| 2019 | 0 | — | 0 | 141 |
| 2020 | 0 | — | 0 | 101 |
| 2021 | 0 | — | 0 | 59 |
| 2022 | 0 | — | 0 | 52 |
| 2023 | 0 | — | 0 | 52 |
| 2024 | 0 | — | 0 | 62 |
| 2025 | 0 | — | 0 | 53 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX System is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion.
The EndoAnchor may be implanted at the time of the initial endograft placement, or during a secondary (i.e., repair) procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171427: Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171427
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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