510(k) · Cleared

Cleared

Mitek Micro Anchor

K962511510(k) TraditionalCleared Nov 6, 1996132-day reviewClass II21 CFR 888.3040

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

Mitek Products · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Nov 6, 1996 after a 132-day review. The FDA summary names its predicate without a number. 17 later devices descend from it.

Decided: Nov 6, 1996
Review: 132 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 0

17 later devices descend from it, 7 citing it directly.

This deviceK962511 Mitek Micro AnchorMitek Products · 1996
Descendant · cites it directly · 7 of its ownK071520 Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC · 2007
Descendant · cites it directly · 5 of its ownK032078 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 · cites it directly · 3 of its ownK101126 Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010
Descendant · 2 generations on · 2 of its ownK110879 Biomet Sports Medicine Juggerknot (TM) Mini Soft AnchorBiomet Sports Medicine · 2011 · Recalled

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

1999high 3 (1999) · low 0 (2000)2026

Most influential descendants

Showing 5 of 17 · See all

K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC · 2007 · cites it directly7descendants
K032078Mitek Micro QuickanchorMitek Worldwide · 2003 · cites it directly5descendants
K080352Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix AQ+ Anchor with…Depuy Mitek, A Johnson & Johnson Company · 2008 · cites it directly4descendants
K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010 · cites it directly3descendants
K110879Biomet Sports Medicine Juggerknot (TM) Mini Soft AnchorBiomet Sports Medicine · 2011 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K962511	Mitek Micro Anchor	Mitek Products	1996	—
+1	K071520	Renovo Suture Anchors, Models 100-2001 Thru 100-5502X	Core Essence Orthopaedics, LLC	2007	—
+1	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	—
+1	K101126	Pontis Sutures and Suture Anchors with Optional Crimps	Core Essence Orthopaedics, Inc.	2010	—
+2	K110879	Biomet Sports Medicine Juggerknot (TM) Mini Soft Anchor	Biomet Sports Medicine	2011	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	3	0
2003	1	0
2007	1	0
2008	1	0
2009	1	0
2010	1	0
2011	2	0
2013	1	0
2014	3	0
2015	1	0
2020	1	0
2026	1	0

FIG. 1 — Lineage of K962511, 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 MBI? 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 MBI device

#1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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
*	—	Suture Named without a submission number			—
†	K915089	Mitek Quickanchor (TM), Modification	Mitek Surgical Products, Inc.	1992	—
†	K930892	Mitek Mini Anchor, Modification	Mitek Surgical Products, Inc.	1994	—

What descends from it? (17)

See all 17

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K071520	Renovo Suture Anchors, Models 100-2001 Thru 100-5502X	Core Essence Orthopaedics, LLC	2007	7
K032078	Mitek Micro Quickanchor	Mitek Worldwide	2003	5
K080352	Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix AQ+ Anchor with…	Depuy Mitek, A Johnson & Johnson Company	2008	4
K101126	Pontis Sutures and Suture Anchors with Optional Crimps	Core Essence Orthopaedics, Inc.	2010	3
K993575	Resolve Quickanchor	Mitek Products	1999	0
K993327	Talon Anchor Snap-Pak	Mitek Products	1999	0
K993261	Talon Anchor Snap-Pak	Mitek Products	1999	0

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?

Of its descendants, K071520 (Core Essence Orthopaedics, LLC, 2007) has gone furthest, with 7 descendants of its own.

How does its category compare?

All MBI devices

MBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MBI

27in 2025

2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007high 107 (2021) · low 30 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MBI

1in 2025

2007high 24 (2007) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MBI

3,826in 2025

2007high 3,826 (2025) · low 240 (2007)2025

MAUDE reports naming product code MBI, 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	16	80	24	240
2008	10	69	6	338
2009	19	82	2	355
2010	17	76	3	291
2011	30	75	23	328
2012	24	94	6	371
2013	31	100	2	442
2014	23	101	0	504
2015	23	85	0	507
2016	17	94	0	795
2017	17	70	4	675
2018	16	91	2	1,072
2019	31	90	0	1,303
2020	35	83	1	1,454
2021	18	107	0	1,890
2022	19	64	0	1,591
2023	52	57	1	2,503
2024	22	30	1	3,779
2025	27	58	1	3,826
2026	30	63	0	—

What is it indicated for?

The device is used to anchor suture into bone. The suture is subsequently used by the surgeon to reattach the repositioned/injured soft tissue to bone. The purpose of this 510(k) submission is to obtain clearance for the Mitek Micro Anchor for the collateral ligament(s) around the (PIP) joint. The intended use is the same as the predicate device, i.e., suture, when used to approximate soft tissue to bone during a period of rehabilitation.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K962511 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962511: Mitek Micro Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962511

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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