510(k) · Cleared

Cleared

Heli-FX EndoAnchor System

K182957510(k) SpecialCleared Nov 21, 201828-day reviewClass II21 CFR 870.3460

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Vascular, Inc. · OTD Endovascular Suturing System

Cleared on Nov 21, 2018 as substantially equivalent to K171427 (Medtronic Vascular, Inc., 2017) after a 28-day review. Its family tree reaches back 6 generations to 2011.

Decided: Nov 21, 2018
Review: 28 days
Class: Class II
Product code: OTD
Recalls: None
Predicates: 1

Its longest line of descent runs back 6 generations to DEN100026 (2011). No later device cites it as a predicate yet.

By dateBy generation

Root · 6 generations backDEN100026 Aptus Steerable Endoguide with Obturator, Aptus Endostaple Applier…Aptus Endosystems, Inc. · 2011
5 generations backK121168 Aptus 18FR Helifx Guide-22 Deflectable LengthAptus Endosystems, Inc. · 2012
4 generations backK130677 Aptus Heli-FX Aortic Securement SystemAptus Endosystems, Inc. · 2013
3 generations backK140036 Aptus Heli-FX Guide - 22CM Deflectable Length; Aptus Heli-FX Guide -…Aptus Endosystems, Inc. · 2014
2 generations backK141041 Aptus Heli-FX Ancillary Endoanchor CassetteAptus Endosystems · 2014
1 generation backK171427 Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteMedtronic Vascular, Inc. · 2017 · Recalled
This deviceK182957 Heli-FX EndoAnchor SystemMedtronic Vascular, Inc. · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	DEN100026	Aptus Steerable Endoguide with Obturator, Aptus Endostaple Applier with…	Aptus Endosystems, Inc.	2011	—
−5	K121168	Aptus 18FR Helifx Guide-22 Deflectable Length	Aptus Endosystems, Inc.	2012	—
−4	K130677	Aptus Heli-FX Aortic Securement System	Aptus Endosystems, Inc.	2013	—
−3	K140036	Aptus Heli-FX Guide - 22CM Deflectable Length; Aptus Heli-FX Guide - 28CM…	Aptus Endosystems, Inc.	2014	—
−2	K141041	Aptus Heli-FX Ancillary Endoanchor Cassette	Aptus Endosystems	2014	—
−1	K171427	Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette	Medtronic Vascular, Inc.	2017	1
0 (this device)	K182957	Heli-FX EndoAnchor System	Medtronic Vascular, Inc.	2018	—

FIG. 1 — Lineage of K182957, 2011–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K171427	Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette Summary page 5 …• Heli-FX Guide • Ancillary EndoAnchor Cassette containing five (5) EndoAnchor implants Predicate Devices • Heli-FX EndoAnchor System per K171427 Intended Use The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and th…	Medtronic Vascular, Inc.	2017	1

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 7 years and passes through 3 companies; a new generation was cleared every 10 months on median.
1 of the 6 ancestors has a recall of any class.

How does its category compare?

All OTD devices

OTD Endovascular Suturing System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · OTD

1in 2018

2007high 2 (2014) · low 0 (2007)2026

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

2007high 215 (2018) · low 0 (2007)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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	1	—	0
2012	1	—	1
2013	1	—	5
2014	2	—	16
2015	0	—	72
2016	0	—	166
2017	1	—	161
2018	1	—	215
2019	0	—	141
2020	0	—	101
2021	0	—	59
2022	0	—	52
2023	0	—	52
2024	0	—	62
2025	0	—	53
2026	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 EndoAnchor 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/K182957 · printed Nov 6, 2026

Cite this page

510(k) Report. “K182957: Heli-FX EndoAnchor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182957

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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