510(k) · Cleared

Cleared

Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor, Rotator Cuff Anchor / Rotator Cuff Quick an..

K111631510(k) TraditionalCleared Jul 22, 201139-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

Depuy Mitek, A Johnson & Johnson Company · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Jul 22, 2011 as substantially equivalent to K915889 (Mitek Surgical Products, Inc., 1992) and 6 other predicates after a 39-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.

Decided: Jul 22, 2011
Review: 39 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 7

Its longest line of descent runs back 4 generations to K010673 (2001). 22 ancestors in all, the oldest K915889 (1992). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK010673 Arthrex Fiberwire, Model Spu-02NB-3800Arthrex, Inc. · 2001
3 generations backK040004 Orthocord SutureDepuy Mitek · 2004 · Recalled
2 generations backK043298 Blue Orthocord SutureDepuy Mitek · 2004 · Recalled
1 generation backK082282 Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co. · 2008
This deviceK111631 Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture…Depuy Mitek, A Johnson & Johnson Company · 2011
Descendant · cites it directly · 0 of its ownK112417 VariousDepuy Mitek, A Johnson & Johnson Company · 2012

Most influential descendants

Showing 1 of 1 · See all

K112417VariousDepuy Mitek, A Johnson & Johnson Company · 2012 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K010673	Arthrex Fiberwire, Model Spu-02NB-3800	Arthrex, Inc.	2001	—
−3	K040004	Orthocord Suture	Depuy Mitek	2004	1
−2	K043298	Blue Orthocord Suture	Depuy Mitek	2004	6
−1	K082282	Healix TI Anchor	Depuy Mitek, A Johnson & Johnson Co.	2008	—
0 (this device)	K111631	Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor…	Depuy Mitek, A Johnson & Johnson Company	2011	—
+1	K112417	Various	Depuy Mitek, A Johnson & Johnson Company	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1993	1	0
1995	1	0
1998	1	0
1999	1	0
2001	2	0
2002	1	0
2004	4	0
2005	3	0
2006	2	0
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0

FIG. 1 — Lineage of K111631, 2001–2012Source: 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 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? (7)

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 …cturing processes. The only proposition of this 510(k) submission is to add a generic "MR- Conditional" statement and symbol to the product package inserts and labels. * K915889, KOS1989 - Gil Anchor/Gil Quick Anchor Plus * K082282 - H-ealix Ti Dual Threaded Suture Anchor * K992611, K052630 -…	Mitek Surgical Products, Inc.	1992	—
*	K051989	Gii Quickanchor Plus with Orthocord Suture	Depuy Mitek, A Johnson & Johnson Company	2005	—
*	K082282	Healix TI Anchor Summary page 1 …submission is to add a generic "MR- Conditional" statement and symbol to the product package inserts and labels. * K915889, KOS1989 - Gil Anchor/Gil Quick Anchor Plus * K082282 - H-ealix Ti Dual Threaded Suture Anchor * K992611, K052630 - Rotator Cuff Anchor/Rotator Cuff Quick Anchor Plus * K…	Depuy Mitek, A Johnson & Johnson Co.	2008	—
*	K992611	Mitek Rotator Cuff Quickanchor Plus Summary page 1 …symbol to the product package inserts and labels. * K915889, KOS1989 - Gil Anchor/Gil Quick Anchor Plus * K082282 - H-ealix Ti Dual Threaded Suture Anchor * K992611, K052630 - Rotator Cuff Anchor/Rotator Cuff Quick Anchor Plus * K930893, K052631 - Super Anchors/Super Quick Anchor Pius === Pag…	Mitek Products	1999	—
*	K052630	Rotator Cuff Quickanchor Plus (with Orthocord Suture) Summary page 1 …the product package inserts and labels. * K915889, KOS1989 - Gil Anchor/Gil Quick Anchor Plus * K082282 - H-ealix Ti Dual Threaded Suture Anchor * K992611, K052630 - Rotator Cuff Anchor/Rotator Cuff Quick Anchor Plus * K930893, K052631 - Super Anchors/Super Quick Anchor Pius…	Depuy Mitek, A Johnson & Johnson Company	2005	—
*	K930893	Mitek Super Quickanchor, Modification Summary page 1 …il Anchor/Gil Quick Anchor Plus * K082282 - H-ealix Ti Dual Threaded Suture Anchor * K992611, K052630 - Rotator Cuff Anchor/Rotator Cuff Quick Anchor Plus * K930893, K052631 - Super Anchors/Super Quick Anchor Pius R e yPRODUCT:…	Mitek Surgical Products, Inc.	1993	—
*	K052631	Super Quickanchor Plus (with Orthocord Suture) Summary page 1 …/Gil Quick Anchor Plus * K082282 - H-ealix Ti Dual Threaded Suture Anchor * K992611, K052630 - Rotator Cuff Anchor/Rotator Cuff Quick Anchor Plus * K930893, K052631 - Super Anchors/Super Quick Anchor Pius R e yPRODUCT: MRI S…	Depuy Mitek, A Johnson & Johnson Company	2005	—

Also cleared against K915889: 5 other devices →

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
K112417	Various	Depuy Mitek, A Johnson & Johnson Company	2012	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?

The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
6 of the 22 ancestors have a recall of any class.
Of its descendants, K112417 (Depuy Mitek, A Johnson & Johnson Company, 2012) has gone furthest, with 0 descendants of its own.
5 other devices also cite its predicate K915889.

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. 2011, this device’s year, is highlighted.

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 DePuy Mitek Super QUICKANCHOR Plus is intended for fixation of USP size #2 through #5 suture to bone for the indications listed below.

Shoulder: Rotator cuff repair; capsular repair; biceps repair; deltoid repair.

Ankle: Achilles tendon repair/reconstruction.

Knee: Extra capsular repairs; reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111631 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111631: Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor, Rotator Cuff Anchor / Rotator Cuff Quick an...” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111631

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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