510(k) Report

510(k) · Cleared

Cleared

Super Quickanchor Plus

K041116510(k) SpecialCleared May 28, 200429-day reviewClass II21 CFR 888.3030

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

Depuy Mitek · JDR Staple, Fixation, Bone

Cleared on May 28, 2004 as substantially equivalent to K930893 (Mitek Surgical Products, Inc., 1993) after a 29-day review. Its family tree reaches back 1 generation to 1993. 23 later devices descend from it.

Decided
May 28, 2004
Review
29 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K930893 (1993). 23 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2011: 4 descendants cleared2008: 1 descendant cleared2014: 3 descendants cleared2019: 1 descendant cleared2012: 1 descendant cleared2021: 2 descendants cleared2025: 1 descendant cleared2013: 2 descendants cleared2023: 2 descendants cleared2024: 1 descendant cleared2022: 1 descendant cleared2026: 2 descendants cleared2018: 1 descendant clearedK930893 · Mitek Super Quickanchor, Modification · Mitek Surgical Products, Inc. · 19931990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 4 descendants5 generations forward: 11 descendants6 generations forward: 1 descendant K930893 · Mitek Super Quickanchor, Modification · Mitek Surgical Products, Inc. · 19930+5
  1. Root · 1 generation backK930893 Mitek Super Quickanchor, ModificationMitek Surgical Products, Inc. · 1993
  2. This deviceK041116 Super Quickanchor PlusDepuy Mitek · 2004
  3. Descendant · cites it directly · 22 of its ownK052631 Super Quickanchor Plus (with Orthocord Suture)Depuy Mitek, A Johnson & Johnson Company · 2005
  4. Descendant · 2 generations on · 21 of its ownK082282 Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co. · 2008
  5. Descendant · 3 generations on · 15 of its ownK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011
  6. Descendant · 4 generations on · 6 of its ownK211002 Grappler Suture Anchor SystemParagon 28, Inc. · 2021 · Recalled
  7. Descendant · 4 generations on · 6 of its ownK103712 Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2005: 12008: 12011: 42012: 12013: 22014: 32018: 12019: 12021: 22022: 12023: 22024: 12025: 12026: 2
2005high 4 (2011) · low 0 (2006)2026

Most influential descendants

Showing 5 of 23 · See all
  • K052631Super Quickanchor Plus (with Orthocord Suture)Depuy Mitek, A Johnson & Johnson Company · 2005 · cites it directly22descendants
  • K082282Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co. · 2008 · 2 generations on21descendants
  • K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company · 2011 · 3 generations on15descendants
  • K211002Grappler Suture Anchor SystemParagon 28, Inc. · 2021 · 4 generations on6descendants
  • K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011 · 4 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K930893Mitek Super Quickanchor, ModificationMitek Surgical Products, Inc.1993—
0 (this device)K041116Super Quickanchor PlusDepuy Mitek2004—
+1K052631Super Quickanchor Plus (with Orthocord Suture)Depuy Mitek, A Johnson & Johnson Company2005—
+2K082282Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co.2008—
+3K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend…Depuy Mitek, A Johnson & Johnson Company2011—
+4K211002Grappler Suture Anchor SystemParagon 28, Inc.20211
+4K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200810
201140
201210
201320
201430
201810
201910
202120
202210
202320
202410
202510
202620
FIG. 1 — Lineage of K041116, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K930893Mitek Super Quickanchor, Modification
Our reading of the summary gave K980893, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SuperAnchor QuickAnchor”.
Mitek Surgical Products, Inc.1993—

Also cleared against K930893: 1 other device →

What descends from it? (23)

See all 23

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

NumberDeviceApplicantDecidedDescendants
K052631Super Quickanchor Plus (with Orthocord Suture)Depuy Mitek, A Johnson & Johnson Company200522

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, K052631 (Depuy Mitek, A Johnson & Johnson Company, 2005) has gone furthest, with 22 descendants of its own.
  • 1 other device also cites its predicate K930893.

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

2007: 82008: 52010: 22011: 12012: 12013: 92014: 112015: 72016: 62017: 92018: 82019: 52020: 42021: 32022: 52023: 92024: 42025: 32026 (partial year): 2
2007high 11 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDR

65in 2025

2007: 70 days median2008: 89 days median2013: 137 days median2014: 97 days median2015: 111 days median2016: 101 days median2017: 172 days median2018: 107 days median2019: 149 days median2020: 161 days median2021: 62 days median2022: 107 days median2023: 72 days median2024: 29 days median2025: 65 days median
2007high 172 (2017) · low 29 (2024)2026

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

Recalls per year · JDR

11in 2022

2008: 12015: 12018: 12020: 12022: 112026 (partial year): 2
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

2007: 32008: 142009: 102010: 352011: 622012: 342013: 272014: 492015: 482016: 762017: 1162018: 2392019: 2422020: 2342021: 2102022: 2022023: 1752024: 2062025: 314
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200787003
2008589114
20090—010
20102—035
20111—062
20121—034
20139137027
20141197049
20157111148
20166101076
201791720116
201881071239
201951490242
202041611234
20213620210
2022510711202
20239720175
20244290206
20253650314
20262—2—

What is it indicated for?

The Mitek Super QUICKANCHOR Anchor 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.

Also cleared against K930893

1 other device cites the same predicate.

  • K111631Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor, Rotator Cuff Anchor / Rotator…Depuy Mitek, A Johnson & Johnson Company · 2011

More from Depuy Mitek

13 FDA decisions under this applicant name. See the company

  • K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek · 2025
  • K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek · 2024
  • K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek · 2024
  • K143475VAPR Tripolar Suction ElectrodeDepuy Mitek · 20151 recall
  • K120449Healix Advance Peek AnchorDepuy Mitek · 2012

Recent decisions in JDR

The JDR category page

  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • K261121Megalodon Dynamic Compression SystemParagon 28, Inc. · 2026
  • K250712Linkt Compression Staple SystemTrax Surgical · 2025
  • K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP · 2025
  • K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc. · 2025

https://510kreport.com/device/K041116 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041116: Super 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/K041116

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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