510(k) Report

510(k) · Cleared

Cleared

Microfix Quickanchor Plus

K024115510(k) TraditionalCleared Mar 13, 200390-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 Worldwide · HWC Screw, Fixation, Bone

Cleared on Mar 13, 2003 after a 90-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.

Decided
Mar 13, 2003
Review
90 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

5 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2014: 1 descendant cleared2011: 1 descendant cleared2013: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK024115 Microfix Quickanchor PlusMitek Worldwide · 2003
  2. Descendant · cites it directly · 4 of its ownK080352 Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix…Depuy Mitek, A Johnson & Johnson Company · 2008
  3. Descendant · 2 generations on · 2 of its ownK110879 Biomet Sports Medicine Juggerknot (TM) Mini Soft AnchorBiomet Sports Medicine · 2011 · Recalled
  4. Descendant · 3 generations on · 0 of its ownK254229 Arthrex Nano FiberTak Suture AnchorArthrex, Inc. · 2026
  5. Descendant · 2 generations on · 0 of its ownK140908 Juggerknot Mini Soft AnchorBiomet Sports Medicine · 2014
  6. Descendant · 2 generations on · 0 of its ownK123668 OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company · 2013

Most influential descendants

Showing 5 of 5 · See all
  • K080352Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix AQ+ Anchor with…Depuy Mitek, A Johnson & Johnson Company · 2008 · cites it directly4descendants
  • K110879Biomet Sports Medicine Juggerknot (TM) Mini Soft AnchorBiomet Sports Medicine · 2011 · 2 generations on2descendants
  • K254229Arthrex Nano FiberTak Suture AnchorArthrex, Inc. · 2026 · 3 generations on0descendants
  • K140908Juggerknot Mini Soft AnchorBiomet Sports Medicine · 2014 · 2 generations on0descendants
  • K123668OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K024115Microfix Quickanchor PlusMitek Worldwide2003—
+1K080352Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix AQ+…Depuy Mitek, A Johnson & Johnson Company2008—
+2K110879Biomet Sports Medicine Juggerknot (TM) Mini Soft AnchorBiomet Sports Medicine20112
+3K254229Arthrex Nano FiberTak Suture AnchorArthrex, Inc.2026—
+2K140908Juggerknot Mini Soft AnchorBiomet Sports Medicine2014—
+2K123668OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201110
201310
201410
202610
FIG. 1 — Lineage of K024115, 2003–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 22.3 · 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
*—MICRO Anchor
Named without a submission number
—
*—Resolve QuickAnchor
Named without a submission number
—
*—BIOFASTIN RC suture anchors
Named without a submission number
—

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K080352Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix AQ+ Anchor with…Depuy Mitek, A Johnson & Johnson Company20084

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, K080352 (Depuy Mitek, A Johnson & Johnson Company, 2008) has gone furthest, with 4 descendants of its own.

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 MICROFIX QUICKANCHOR Plus is intended for fixation of soft tissue to bone, using suture, for the indications listed below:

Hand: Repair/reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalangeal), DIP (distal interphalangeal) and MCP (metacarpal interphalangeal) joints for all digits.

Skull: Soft tissue attachment to the parietal, temporal ridge, frontal, mandible, maxilla, zygoma, and periorbital bones of the skull.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K024115: Microfix Quickanchor Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024115

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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