510(k) Report

510(k) · Cleared

Cleared

Mitek Super Quickanchor, Modification

K930893510(k) TraditionalCleared Dec 8, 1993313-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

Mitek Surgical Products, Inc. · JDR Staple, Fixation, Bone

Cleared on Dec 8, 1993 after a 313-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 24 later devices descend from it.

Decided
Dec 8, 1993
Review
313 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
0

24 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2011: 4 descendants cleared2004: 1 descendant cleared2005: 1 descendant cleared2012: 1 descendant cleared2008: 1 descendant cleared2014: 3 descendants cleared2019: 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 cleared1990200020102020
  1. This deviceK930893 Mitek Super Quickanchor, ModificationMitek Surgical Products, Inc. · 1993
  2. Descendant · cites it directly · 23 of its ownK041116 Super Quickanchor PlusDepuy Mitek · 2004
  3. Descendant · 2 generations on · 22 of its ownK052631 Super Quickanchor Plus (with Orthocord Suture)Depuy Mitek, A Johnson & Johnson Company · 2005
  4. Descendant · 3 generations on · 21 of its ownK082282 Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co. · 2008
  5. Descendant · 4 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 · 5 generations on · 6 of its ownK211002 Grappler Suture Anchor SystemParagon 28, Inc. · 2021 · Recalled

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12008: 12011: 42012: 12013: 22014: 32018: 12019: 12021: 22022: 12023: 22024: 12025: 12026: 2
2004high 4 (2011) · low 0 (2006)2026

Most influential descendants

Showing 5 of 24 · See all
  • K041116Super Quickanchor PlusDepuy Mitek · 2004 · cites it directly23descendants
  • K052631Super Quickanchor Plus (with Orthocord Suture)Depuy Mitek, A Johnson & Johnson Company · 2005 · 2 generations on22descendants
  • K082282Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co. · 2008 · 3 generations on21descendants
  • K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company · 2011 · 4 generations on15descendants
  • K211002Grappler Suture Anchor SystemParagon 28, Inc. · 2021 · 5 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K930893Mitek Super Quickanchor, ModificationMitek Surgical Products, Inc.1993—
+1K041116Super Quickanchor PlusDepuy Mitek2004—
+2K052631Super Quickanchor Plus (with Orthocord Suture)Depuy Mitek, A Johnson & Johnson Company2005—
+3K082282Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co.2008—
+4K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend…Depuy Mitek, A Johnson & Johnson Company2011—
+5K211002Grappler Suture Anchor SystemParagon 28, Inc.20211

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200810
201140
201210
201320
201430
201810
201910
202120
202210
202320
202410
202510
202620
FIG. 1 — Lineage of K930893, 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (24)

See all 24

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

NumberDeviceApplicantDecidedDescendants
K041116Super Quickanchor PlusDepuy Mitek200423
K111631Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor, Rotator Cuff…Depuy Mitek, A Johnson & Johnson Company20111

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?

  • Of its descendants, K041116 (Depuy Mitek, 2004) has gone furthest, with 23 descendants of its own.

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—
Cite this page

510(k) Report. “K930893: Mitek Super Quickanchor, Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K930893

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026