510(k) · Cleared

Cleared

Mitek Rotator Cuff Quickanchor Plus

K992611510(k) TraditionalCleared Sep 22, 199949-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 · HWC Screw, Fixation, Bone

Cleared on Sep 22, 1999 as substantially equivalent to K915889 (Mitek Surgical Products, Inc., 1992) after a 49-day review. Its family tree reaches back 1 generation to 1992. 4 later devices descend from it.

Decided: Sep 22, 1999
Review: 49 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K915889 (1992). 4 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK915889 Mitek Bone Anchor, ModificationMitek Surgical Products, Inc. · 1992
This deviceK992611 Mitek Rotator Cuff Quickanchor PlusMitek Products · 1999
Descendant · cites it directly · 2 of its ownK052630 Rotator Cuff Quickanchor Plus (with Orthocord Suture)Depuy Mitek, A Johnson & Johnson Company · 2005
Descendant · cites it directly · 1 of its ownK111631 Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture…Depuy Mitek, A Johnson & Johnson Company · 2011
Descendant · 2 generations on · 0 of its ownK112417 VariousDepuy Mitek, A Johnson & Johnson Company · 2012
Descendant · cites it directly · 0 of its ownK993575 Resolve QuickanchorMitek Products · 1999

Most influential descendants

Showing 4 of 4 · See all

K052630Rotator Cuff Quickanchor Plus (with Orthocord Suture)Depuy Mitek, A Johnson & Johnson Company · 2005 · cites it directly2descendants
K111631Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor, Rotator Cuff…Depuy Mitek, A Johnson & Johnson Company · 2011 · cites it directly1descendant
K112417VariousDepuy Mitek, A Johnson & Johnson Company · 2012 · 2 generations on0descendants
K993575Resolve QuickanchorMitek Products · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K915889	Mitek Bone Anchor, Modification	Mitek Surgical Products, Inc.	1992	—
0 (this device)	K992611	Mitek Rotator Cuff Quickanchor Plus	Mitek Products	1999	—
+1	K052630	Rotator Cuff Quickanchor Plus (with Orthocord Suture)	Depuy Mitek, A Johnson & Johnson Company	2005	—
+1	K111631	Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor…	Depuy Mitek, A Johnson & Johnson Company	2011	—
+2	K112417	Various	Depuy Mitek, A Johnson & Johnson Company	2012	—
+1	K993575	Resolve Quickanchor	Mitek Products	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2005	1	0
2011	1	0
2012	1	0

FIG. 1 — Lineage of K992611, 1992–2012Source: 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 HWC? 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 HWC device

#1 K203011 Monster Screw Systemscore 22.2 · 14 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
*	K915889	Mitek Bone Anchor, Modification Summary page 1 …ion: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. Product Code: HWC (21 CFR 888.3040) Predicate Devices: K915889 - Mitek Anchor Product Description: The device described in this 510(k) is a sterile, disposable bone anchor consisting of a tit…	Mitek Surgical Products, Inc.	1992	—

Also cleared against K915889: 5 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K052630	Rotator Cuff Quickanchor Plus (with Orthocord Suture)	Depuy Mitek, A Johnson & Johnson Company	2005	2
K111631	Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor, Rotator Cuff…	Depuy Mitek, A Johnson & Johnson Company	2011	1
K993575	Resolve Quickanchor	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?

Its one ancestor has no recall.
Of its descendants, K052630 (Depuy Mitek, A Johnson & Johnson Company, 2005) has gone furthest, with 2 descendants of its own.
5 other devices also cite its predicate K915889.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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	35	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

What is it indicated for?

The Mitek Rotator Cuff QuickAnchor® Plus is indicated for Rotator cuff repair.

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/K992611 · printed Nov 5, 2026

Cite this page

510(k) Report. “K992611: Mitek Rotator Cuff Quickanchor Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992611

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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