510(k) · Cleared

Recalled · Class II · 2013

Gii Quickanchor Plus

K041115510(k) SpecialCleared May 28, 200429-day reviewClass II21 CFR 888.3030Recalls 1

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 · JDR Staple, Fixation, Bone

Cleared on May 28, 2004 as substantially equivalent to K915889 (Mitek Surgical Products, Inc., 1992) after a 29-day review. Its family tree reaches back 1 generation to 1992. 14 later devices descend from it. It has been recalled once.

Decided: May 28, 2004
Review: 29 days
Class: Class II
Product code: JDR
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K915889 (1992). 14 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK915889 Mitek Bone Anchor, ModificationMitek Surgical Products, Inc. · 1992
This deviceK041115 Gii Quickanchor PlusDepuy Mitek, A Johnson & Johnson Company · 2004
Descendant · cites it directly · 7 of its ownK112876 Cufflink (TM) Knotless Anchor with Inserter, 4.5MM/5.5MM - Peek…Cayenne Medical, Inc. · 2011
Descendant · 2 generations on · 6 of its ownK122314 Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek OnlyCayenne Medical, Inc. · 2012
Descendant · cites it directly · 3 of its ownK051989 Gii Quickanchor Plus with Orthocord SutureDepuy Mitek, A Johnson & Johnson Company · 2005
Descendant · 3 generations on · 2 of its ownK182507 Tigon Medical Tissue AnchorsTigon Medical · 2019
Descendant · 4 generations on · 1 of its ownK220464 Tigon Medical Gryphon Anchor LineTigon Medical · 2023

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2005high 3 (2011) · low 0 (2006)2026

Most influential descendants

Showing 5 of 14 · See all

K112876Cufflink (TM) Knotless Anchor with Inserter, 4.5MM/5.5MM - Peek Only, Cufflink SP (TM)…Cayenne Medical, Inc. · 2011 · cites it directly7descendants
K122314Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek OnlyCayenne Medical, Inc. · 2012 · 2 generations on6descendants
K051989Gii Quickanchor Plus with Orthocord SutureDepuy Mitek, A Johnson & Johnson Company · 2005 · cites it directly3descendants
K182507Tigon Medical Tissue AnchorsTigon Medical · 2019 · 3 generations on2descendants
K220464Tigon Medical Gryphon Anchor LineTigon Medical · 2023 · 4 generations on1descendant

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)	K041115	Gii Quickanchor Plus	Depuy Mitek, A Johnson & Johnson Company	2004	—
+1	K112876	Cufflink (TM) Knotless Anchor with Inserter, 4.5MM/5.5MM - Peek Only, Cufflink…	Cayenne Medical, Inc.	2011	—
+2	K122314	Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek Only	Cayenne Medical, Inc.	2012	—
+1	K051989	Gii Quickanchor Plus with Orthocord Suture	Depuy Mitek, A Johnson & Johnson Company	2005	—
+3	K182507	Tigon Medical Tissue Anchors	Tigon Medical	2019	—
+4	K220464	Tigon Medical Gryphon Anchor Line	Tigon Medical	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2007	1	0
2011	3	0
2012	2	0
2014	1	0
2015	1	0
2019	2	0
2021	1	0
2023	1	0
2026	1	0

FIG. 1 — Lineage of K041115, 1992–2026Source: 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 JDR? 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 JDR device

#1 K243658 TMC Compression Implant Systemscore 16.7 · 18 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
*	K915889	Mitek Bone Anchor, Modification Summary page 2 …reattachment of soft tissue to bone. The anchor is identical to the currently marketed Mitek GII Anchor (K915889). Substantial Equivalence Based on the type of changes being made and the fact that the GII…	Mitek Surgical Products, Inc.	1992	—

Also cleared against K915889: 5 other devices →

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K112876	Cufflink (TM) Knotless Anchor with Inserter, 4.5MM/5.5MM - Peek Only, Cufflink SP (TM)…	Cayenne Medical, Inc.	2011	7
K051989	Gii Quickanchor Plus with Orthocord Suture	Depuy Mitek, A Johnson & Johnson Company	2005	3
K133579	Multifilament Stainless Steel Sutures with Crimps	Pontis Orthopaedics, LLC	2014	0
K070773	Axya, Model 3000 Axyzloop Titanium Bone Anchor	Axya Medical, Inc.	2007	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 3, 2013	Class II	Z-1626-2013	Packaging process control	The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K112876 (Cayenne Medical, Inc., 2011) has gone furthest, with 7 descendants of its own.
5 other devices also cite its predicate K915889.

How does its category compare?

All JDR devices

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

FDA decisions per year · JDR

3in 2025

2007high 11 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDR

65in 2025

2007high 172 (2017) · low 29 (2024)2026

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

Recalls per year · JDR

11in 2022

2007high 11 (2022) · low 0 (2007)2026

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

Adverse event reports per year · JDR

314in 2025

2007high 314 (2025) · low 3 (2007)2025

MAUDE reports naming product code JDR, 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	8	70	0	3
2008	5	89	1	14
2009	0	—	0	10
2010	2	—	0	35
2011	1	—	0	62
2012	1	—	0	34
2013	9	137	0	27
2014	11	97	0	49
2015	7	111	1	48
2016	6	101	0	76
2017	9	172	0	116
2018	8	107	1	239
2019	5	149	0	242
2020	4	161	1	234
2021	3	62	0	210
2022	5	107	11	202
2023	9	72	0	175
2024	4	29	0	206
2025	3	65	0	314
2026	2	—	2	—

What is it indicated for?

The Mitek GII Anchor (QUICKANCHOR) is intended for fixation of USP size #2 suture to bone for the indications listed below. Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis, deltoid repair. Ankle: Lateral instability, medial instability, achilles tendon repair/reconstruction, midfoot reconstruction. Foot: Hallux valgus reconstruction. Wrist…

Read the full statement (108 words)

The Mitek GII Anchor (QUICKANCHOR) is intended for fixation of USP size #2 suture to bone for the indications listed below.

Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis, deltoid repair.

Ankle: Lateral instability, medial instability, achilles tendon repair/reconstruction, midfoot reconstruction.

Foot: Hallux valgus reconstruction.

Wrist: Scapholunate ligament.

Hand: Ulnar or lateral collateral ligament reconstruction.

Elbow: Tennis elbow repair, biceps tendon reattachment.

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/K041115 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041115: Gii Quickanchor Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041115

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