510(k) · Cleared

Cleared

Mitek Micro Quickanchor

K032078510(k) TraditionalCleared Aug 25, 200349-day reviewClass II21 CFR 888.3030

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

Mitek Worldwide · NOV Anchor, Suture, Bone Fixation, Metallic

Cleared on Aug 25, 2003 as substantially equivalent to K962793 (Mitek Products, 1996) and 2 other predicates after a 49-day review. Its family tree reaches back 1 generation to 1996. 5 later devices descend from it.

Decided: Aug 25, 2003
Review: 49 days
Class: Class II
Product code: NOV
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K962793 (1996). 3 ancestors in all. 5 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK962793 Mitek Micro AnchorMitek Products · 1996
This deviceK032078 Mitek Micro QuickanchorMitek Worldwide · 2003
Descendant · cites it directly · 4 of its ownK080352 Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix…Depuy Mitek, A Johnson & Johnson Company · 2008
Descendant · 2 generations on · 2 of its ownK110879 Biomet Sports Medicine Juggerknot (TM) Mini Soft AnchorBiomet Sports Medicine · 2011 · Recalled
Descendant · 3 generations on · 0 of its ownK254229 Arthrex Nano FiberTak Suture AnchorArthrex, Inc. · 2026
Descendant · 2 generations on · 0 of its ownK140908 Juggerknot Mini Soft AnchorBiomet Sports Medicine · 2014
Descendant · 2 generations on · 0 of its ownK123668 OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company · 2013

Most influential descendants

Showing 5 of 5 · See all

K080352Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix AQ+ Anchor with…Depuy Mitek, A Johnson & Johnson Company · 2008 · cites it directly4descendants
K110879Biomet Sports Medicine Juggerknot (TM) Mini Soft AnchorBiomet Sports Medicine · 2011 · 2 generations on2descendants
K254229Arthrex Nano FiberTak Suture AnchorArthrex, Inc. · 2026 · 3 generations on0descendants
K140908Juggerknot Mini Soft AnchorBiomet Sports Medicine · 2014 · 2 generations on0descendants
K123668OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company · 2013 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K962793	Mitek Micro Anchor	Mitek Products	1996	—
0 (this device)	K032078	Mitek Micro Quickanchor	Mitek Worldwide	2003	—
+1	K080352	Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix AQ+…	Depuy Mitek, A Johnson & Johnson Company	2008	—
+2	K110879	Biomet Sports Medicine Juggerknot (TM) Mini Soft Anchor	Biomet Sports Medicine	2011	2
+3	K254229	Arthrex Nano FiberTak Suture Anchor	Arthrex, Inc.	2026	—
+2	K140908	Juggerknot Mini Soft Anchor	Biomet Sports Medicine	2014	—
+2	K123668	Orthocord	Depuy Mitek, Inc., A Johnson and Johnson Company	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2011	1	0
2013	1	0
2014	1	0
2026	1	0

FIG. 1 — Lineage of K032078, 1996–2026Source: 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 NOV? 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

Get a 510(k) Report

What was it cleared against? (3)

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
*	K962793	Mitek Micro Anchor Summary page 1 …Proprietary Name: Micro QuickAnchor Substantial Equivalence M c r o Quick Anchor has been cleared by FDA: K962793, K962511, K982420 Device Classification Suture Anchors are Class I1 devices. Device Description MITEK anchor…	Mitek Products	1996	—
*	K962511	Mitek Micro Anchor Summary page 1 …Proprietary Name: Micro QuickAnchor Substantial Equivalence M c r o Quick Anchor has been cleared by FDA: K962793, K962511, K982420 Device Classification Suture Anchors are Class I1 devices. Device Description MITEK anchors are tit…	Mitek Products	1996	—
*	K982420	Mitek Micro Anchor Summary page 1 …Proprietary Name: Micro QuickAnchor Substantial Equivalence M c r o Quick Anchor has been cleared by FDA: K962793, K962511, K982420 Device Classification Suture Anchors are Class I1 devices. Device Description MITEK anchors are titanium all…	Mitek Products	1998	—

Also cleared against K962793: 2 other devices →

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K080352	Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix AQ+ Anchor with…	Depuy Mitek, A Johnson & Johnson Company	2008	4

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?

None of the 3 ancestors has a recall.
Of its descendants, K080352 (Depuy Mitek, A Johnson & Johnson Company, 2008) has gone furthest, with 4 descendants of its own.
2 other devices also cite its predicate K962793.

How does its category compare?

All NOV devices

NOV Anchor, Suture, Bone Fixation, Metallic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NOV

FDA has decided no NOV device since 2007.

Median 510(k) review, days · NOV

Too few NOV 510(k)s in any year since 2007 to give a median.

Recalls per year · NOV

No recall names NOV since 2007.

Adverse event reports per year · NOV

1in 2022

2007high 5 (2010) · low 0 (2013)2025

MAUDE reports naming product code NOV, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	4
2008	—	4
2009	—	3
2010	—	5
2011	—	1
2012	—	4
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	3
2018	—	1
2019	—	0
2020	—	0
2021	—	0
2022	—	1
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

MITEK Micro QuickAnchor is intended to attach suture into bone for the suspension of the nasal valve.

MITEK Micro QuickAnchor is intended to attach suture into bone at the lower orbital rim.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032078 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032078: Mitek Micro Quickanchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032078

Report an extraction error

Are you the manufacturer?

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