510(k) Report

510(k) · Cleared

Cleared

Quickanchor (TM)

K904436510(k) TraditionalCleared Dec 11, 199074-day reviewClass II21 CFR 878.5000

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. · GAS Suture, Nonabsorbable, Synthetic, Polyester

Cleared on Dec 11, 1990 after a 74-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 536 later devices descend from it.

Decided
Dec 11, 1990
Review
74 days
Class
Class II
Product code
GAS
Recalls
None
Predicates
0

536 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 1996: 3 descendants cleared1997: 3 descendants cleared2007: 6 descendants cleared1998: 2 descendants cleared2009: 11 descendants cleared2001: 2 descendants cleared2020: 33 descendants cleared2010: 7 descendants cleared2017: 26 descendants cleared2018: 19 descendants cleared2011: 14 descendants cleared2023: 45 descendants cleared2002: 4 descendants cleared2003: 2 descendants cleared2008: 9 descendants cleared1999: 4 descendants cleared2004: 4 descendants cleared2006: 7 descendants cleared2013: 18 descendants cleared2012: 8 descendants cleared2014: 24 descendants cleared2019: 34 descendants cleared2026: 52 descendants cleared2022: 33 descendants cleared2005: 4 descendants cleared2015: 14 descendants cleared2016: 12 descendants cleared2025: 55 descendants cleared2024: 50 descendants cleared2021: 31 descendants cleared1990200020102020
  1. This deviceK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
  2. Descendant · cites it directly · 531 of its ownK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
  3. Descendant · 2 generations on · 393 of its ownK973015 Multitak SS Suture SystemBonutti Research · 1997
  4. Descendant · 3 generations on · 336 of its ownK990156 Multitak SS ButtonsBonutti Research · 1999
  5. Descendant · 4 generations on · 309 of its ownK033717 Transet Fracture Fixation SystemBonutti Research, Inc. · 2004
  6. Descendant · 5 generations on · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005

Showing 5 of 536 descendants. See all descendants

Descendants cleared per year

1996: 31997: 31998: 21999: 42001: 22002: 42003: 22004: 42005: 42006: 72007: 62008: 92009: 112010: 72011: 142012: 82013: 182014: 242015: 142016: 122017: 262018: 192019: 342020: 332021: 312022: 332023: 452024: 502025: 552026: 52
1996high 55 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 536 · See all
  • K962397Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996 · cites it directly531descendants
  • K973015Multitak SS Suture SystemBonutti Research · 1997 · 2 generations on393descendants
  • K990156Multitak SS ButtonsBonutti Research · 1999 · 3 generations on336descendants
  • K033717Transet Fracture Fixation SystemBonutti Research, Inc. · 2004 · 4 generations on309descendants
  • K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · 5 generations on306descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K904436Quickanchor (TM)Mitek Surgical Products, Inc.1990—
+1K962397Statak Soft Tissue Attachment DeviceZimmer, Inc.1996—
+2K973015Multitak SS Suture SystemBonutti Research1997—
+3K990156Multitak SS ButtonsBonutti Research1999—
+4K033717Transet Fracture Fixation SystemBonutti Research, Inc.2004—
+5K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.…Arthrex, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199630
199730
199820
199940
200120
200240
200320
200440
200540
200670
200760
200890
2009110
201070
2011140
201280
2013180
2014240
2015140
2016120
2017260
2018190
2019340
2020330
2021310
2022330
2023450
2024500
2025550
2026520
FIG. 1 — Lineage of K904436, 1990–2026Source: 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 GAS? 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 GAS device

  1. #1 K203081 RAM COR-SUTURE QUCIK LOAD Surgical Suture…score 1.9 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (536)

See all 536

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

NumberDeviceApplicantDecidedDescendants
K962397Statak Soft Tissue Attachment DeviceZimmer, Inc.1996531
K963812LM Bone Anchor (Orthopedics)Li Medical Technologies, Inc.199658
K971144Multitak SS Suture SystemBonutti Research19970
K964324Multitak SS Suture SystemBonutti Research19970
K963288LM Bone AnchorLi Medical Technologies, Inc.19960

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, K962397 (Zimmer, Inc., 1996) has gone furthest, with 531 descendants of its own.

How does its category compare?

All GAS devices

GAS Suture, Nonabsorbable, Synthetic, Polyester: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAS

2in 2020

2010: 12020: 2
2007high 2 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAS

Too few GAS 510(k)s in any year since 2007 to give a median.

Recalls per year · GAS

No recall names GAS since 2007.

Adverse event reports per year · GAS

3in 2025

2007: 352008: 472009: 562010: 242011: 252012: 732013: 212014: 122015: 12016: 22018: 32020: 12024: 12025: 3
2007high 73 (2012) · low 0 (2017)2025

MAUDE reports naming product code GAS, 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
20070—035
20080—047
20090—056
20101—024
20110—025
20120—073
20130—021
20140—012
20150—01
20160—02
20170—00
20180—03
20190—00
20202—01
20210—00
20220—00
20230—00
20240—01
20250—03
20260—0—

More from Mitek Surgical Products, Inc.

31 FDA decisions under this applicant name. See the company

  • K953560Mitek Threaded Anchor (Fastin)Mitek Surgical Products, Inc. · 1996
  • K953877Mitek Gii AnchorMitek Surgical Products, Inc. · 1995
  • K936311Mitek Mini AnchorMitek Surgical Products, Inc. · 1995
  • K941599Mitek Absorbable AnchorMitek Surgical Products, Inc. · 1995
  • K944051Absorbalbe AnchorMitek Surgical Products, Inc. · 1995

Recent decisions in GAS

The GAS category page

  • K203120RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0…Lsi Solutions, Inc. · 2020
  • K203081RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureLsi Solutions · 2020
  • K091018Arthrex BiowireArthrex, Inc. · 2010
  • K002261MR-IIISmith & Nephew, Inc. · 2000
  • K953128Suture CordPhoenix Biomedical Corp. · 1996

https://510kreport.com/device/K904436 · printed Nov 4, 2026

Cite this page

510(k) Report. “K904436: Quickanchor (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K904436

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