510(k) Report

510(k) · Cleared

Cleared

Mitek Mini Quickanchor Plus

K992487510(k) TraditionalCleared Sep 21, 199957-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

Mitek Products · HWC Screw, Fixation, Bone

Cleared on Sep 21, 1999 as substantially equivalent to K921873 (Mitek Surgical Products, Inc., 1992) and 2 other predicates after a 57-day review. Its family tree reaches back 1 generation to 1992. 67 later devices descend from it.

Decided
Sep 21, 1999
Review
57 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K921873 (1992). 3 ancestors in all. 67 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1994: 1 other ancestor2007: 3 descendants cleared2003: 1 descendant cleared2006: 1 descendant cleared2014: 4 descendants cleared2011: 9 descendants cleared2019: 2 descendants cleared2020: 3 descendants cleared2016: 2 descendants cleared2013: 8 descendants cleared2009: 4 descendants cleared2012: 5 descendants cleared2021: 1 descendant cleared2015: 8 descendants cleared2026: 3 descendants cleared2008: 2 descendants cleared2010: 4 descendants cleared2022: 2 descendants cleared2024: 1 descendant cleared2017: 2 descendants cleared2025: 2 descendants clearedK921873 · Quickanchor, Modification · Mitek Surgical Products, Inc. · 19921990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 8 descendants2 generations forward: 13 descendants3 generations forward: 10 descendants4 generations forward: 10 descendants5 generations forward: 19 descendants6 generations forward: 6 descendants7 generations forward: 1 descendant K921873 · Quickanchor, Modification · Mitek Surgical Products, Inc. · 19920+5
  1. Root · 1 generation backK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
  2. This deviceK992487 Mitek Mini Quickanchor PlusMitek Products · 1999
  3. Descendant · cites it directly · 50 of its ownK061349 Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006
  4. Descendant · 2 generations on · 27 of its ownK070227 Opus Magnum PI Knotless Fixation DeviceArthrocare Corp. · 2007
  5. Descendant · 2 generations on · 18 of its ownK090615 Opus Speedlock Knotless Fixation DeviceArthrocare Corp. · 2009 · Recalled
  6. Descendant · 3 generations on · 16 of its ownK081893 Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500Arthrocare Corp. · 2008
  7. Descendant · 4 generations on · 15 of its ownK100457 Opus Speedscrew SystemArthrocare Corp. · 2010

Showing 5 of 67 descendants. See all descendants

Descendants cleared per year

2003: 12006: 12007: 32008: 22009: 42010: 42011: 92012: 52013: 82014: 42015: 82016: 22017: 22019: 22020: 32021: 12022: 22024: 12025: 22026: 3
2003high 9 (2011) · low 0 (2004)2026

Most influential descendants

Showing 5 of 67 · See all
  • K061349Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006 · cites it directly50descendants
  • K070227Opus Magnum PI Knotless Fixation DeviceArthrocare Corp. · 2007 · 2 generations on27descendants
  • K090615Opus Speedlock Knotless Fixation DeviceArthrocare Corp. · 2009 · 2 generations on18descendants
  • K081893Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500Arthrocare Corp. · 2008 · 3 generations on16descendants
  • K100457Opus Speedscrew SystemArthrocare Corp. · 2010 · 4 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K921873Quickanchor, ModificationMitek Surgical Products, Inc.1992—
0 (this device)K992487Mitek Mini Quickanchor PlusMitek Products1999—
+1K061349Opus Labralock P Knotless Fixation DeviceArthrocare Corp.2006—
+2K070227Opus Magnum PI Knotless Fixation DeviceArthrocare Corp.2007—
+2K090615Opus Speedlock Knotless Fixation DeviceArthrocare Corp.20091
+3K081893Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500Arthrocare Corp.2008—
+4K100457Opus Speedscrew SystemArthrocare Corp.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200610
200730
200820
200940
201040
201190
201250
201380
201440
201580
201620
201720
201920
202030
202110
202220
202410
202520
202630
FIG. 1 — Lineage of K992487, 1992–2026Source: 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 HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 14 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? (3)

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
*K921873Quickanchor, Modification
Summary page 1
…on: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. Product Code: HWC (21 CFR 888.3040) Predicate Devices: K921873 - Mitek GII Mini QuickAnchor K930892 - Mitek Mini Anchor K936311 - Mitek Mini Anchor Product Description: The device described i…
Mitek Surgical Products, Inc.1992—
*K930892Mitek Mini Anchor, Modification
Summary page 1
…ederal Food, Drug, and Cosmetic Act, the device classification is Class II. Product Code: HWC (21 CFR 888.3040) Predicate Devices: K921873 - Mitek GII Mini QuickAnchor K930892 - Mitek Mini Anchor K936311 - Mitek Mini Anchor Product Description: The device described in this 510(k) is a sterile, disposabl…
Mitek Surgical Products, Inc.1994—
*K936311Mitek Mini Anchor
Summary page 1
…tic Act, the device classification is Class II. Product Code: HWC (21 CFR 888.3040) Predicate Devices: K921873 - Mitek GII Mini QuickAnchor K930892 - Mitek Mini Anchor K936311 - Mitek Mini Anchor Product Description: The device described in this 510(k) is a sterile, disposable bone anchor consisting of…
Mitek Surgical Products, Inc.1995—

Also cleared against K921873: 2 other devices →

What descends from it? (67)

See all 67

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

NumberDeviceApplicantDecidedDescendants
K061349Opus Labralock P Knotless Fixation DeviceArthrocare Corp.200650
K030995Minilok Quickanchor PlusMitek Worldwide200312
K071257Mini Quickanchor and Quickanchor Plus with OrthocordDepuy Mitek, A Johnson & Johnson Company20078
K110879Biomet Sports Medicine Juggerknot (TM) Mini Soft AnchorBiomet Sports Medicine20112
K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201
K182439TruShot with Y-Knot Shallow All-Suture AnchorConmed Corporation20190
K140908Juggerknot Mini Soft AnchorBiomet Sports Medicine20140
K071941Memometal Bone AnchorsMemometal Technologies20070

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K061349 (Arthrocare Corp., 2006) has gone furthest, with 50 descendants of its own.
  • 2 other devices also cite its predicate K921873.

How does its category compare?

All HWC devices

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

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The Mitek Mini QuickAnchor® Plus is indicated for:

shoulder (Bankart repair)

ankle (Mid-foot reconstruction)

foot (Hallux valgus reconstruction)

hand (Ulnar or lateral collateral ligament reconstruction)

wrist (Scapholunate ligament reconstruction)

pubis (For relief from Stress Urinary Incontinence due to urethral or bladder neck hypermobility with minimal or no cystocele).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K921873

2 other devices cite the same predicate.

  • K992623Mitek Mini AnchorMitek Products · 1999
  • K960448LM AnchorLi Medical Technologies, Inc. · 1996

More from Mitek Products

30 FDA decisions under this applicant name. See the company

  • K013572Mitek Biocryl Interference ScrewsMitek Products · 2002
  • K013781Rididfix 2.7MM BTB Cross Pin KitMitek Products · 2002
  • K002639Bioknotless AnchorMitek Products · 20012 recalls
  • K010633Rigidfix Soft Tissue Acl Crosspin SystemMitek Products · 2001
  • K002406Mitek 2GII Meniscal Repair SystemMitek Products · 2001

Recent decisions in HWC

The HWC category page

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  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K992487 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992487: Mitek Mini 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/K992487

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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