510(k) · Cleared

Cleared

Mitek Threaded Anchor (Modification)

K961094510(k) TraditionalCleared Oct 3, 1996203-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 Oct 3, 1996 as substantially equivalent to K945203 (Mitek Surgical Products, Inc., 1995) after a 203-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: Oct 3, 1996
Review: 203 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K945203 (1995). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK945203 Mitek Thraded Anchor (Mta)Mitek Surgical Products, Inc. · 1995
This deviceK961094 Mitek Threaded Anchor (Modification)Mitek Products · 1996
Descendant · cites it directly · 0 of its ownK963502 Csco Forehead Fixation SystemHowmedica Corp. · 1997

Most influential descendants

Showing 1 of 1 · See all

K963502Csco Forehead Fixation SystemHowmedica Corp. · 1997 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K945203	Mitek Thraded Anchor (Mta)	Mitek Surgical Products, Inc.	1995	—
0 (this device)	K961094	Mitek Threaded Anchor (Modification)	Mitek Products	1996	—
+1	K963502	Csco Forehead Fixation System	Howmedica Corp.	1997	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K961094, 1995–1997Source: 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

Get a 510(k) Report

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
*	K945203	Mitek Thraded Anchor (Mta) Summary page 1 …length. It is manufactured from Titanium 6Al 4V. It is similar in design to the 3.0mm, 4.0mm and the 5.2mm Mitek Threaded Anchor. These designs were cleared to market in K945203. MATERIALS USED The Mitek Threaded Anchor delivery system consists of a Mitek Threaded Anchor Tab, a drill bit ,and an Inserter.…	Mitek Surgical Products, Inc.	1995	—

Also cleared against K945203: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K963502	Csco Forehead Fixation System	Howmedica Corp.	1997	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?

Its one ancestor has no recall.
Of its descendants, K963502 (Howmedica Corp., 1997) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K945203.

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 intoc 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 expand the indications to include the browlift procedure. 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/K961094 · printed Nov 5, 2026

Cite this page

510(k) Report. “K961094: Mitek Threaded Anchor (Modification).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961094

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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