510(k) Report

510(k) · Cleared

Cleared

Mitek Micro Anchor

K962793510(k) TraditionalCleared Oct 1, 199676-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 Products · JDR Staple, Fixation, Bone

Cleared on Oct 1, 1996 after a 76-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.

Decided
Oct 1, 1996
Review
76 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
0

14 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2003: 1 descendant cleared2008: 1 descendant cleared2020: 1 descendant cleared2009: 1 descendant cleared2010: 1 descendant cleared2014: 3 descendants cleared2011: 2 descendants cleared2013: 1 descendant cleared2026: 1 descendant cleared2015: 1 descendant clearedReference device: K915089 · Mitek Quickanchor (TM), Modification · Mitek Surgical Products, Inc. · 1992Reference device: K930892 · Mitek Mini Anchor, Modification · Mitek Surgical Products, Inc. · 19941995200020052010201520202025
  1. This deviceK962793 Mitek Micro AnchorMitek Products · 1996
  2. Descendant · cites it directly · 7 of its ownK071520 Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC · 2007
  3. Descendant · cites it directly · 5 of its ownK032078 Mitek Micro QuickanchorMitek Worldwide · 2003
  4. 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
  5. Descendant · 2 generations on · 3 of its ownK101126 Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010
  6. Descendant · 2 generations on · 2 of its ownK110879 Biomet Sports Medicine Juggerknot (TM) Mini Soft AnchorBiomet Sports Medicine · 2011 · Recalled

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2003: 12007: 12008: 12009: 12010: 12011: 22013: 12014: 32015: 12020: 12026: 1
2003high 3 (2014) · low 0 (2004)2026

Most influential descendants

Showing 5 of 14 · See all
  • K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC · 2007 · cites it directly7descendants
  • K032078Mitek Micro QuickanchorMitek Worldwide · 2003 · cites it directly5descendants
  • K080352Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix AQ+ Anchor with…Depuy Mitek, A Johnson & Johnson Company · 2008 · cites it directly4descendants
  • K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010 · 2 generations on3descendants
  • K110879Biomet Sports Medicine Juggerknot (TM) Mini Soft AnchorBiomet Sports Medicine · 2011 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K962793Mitek Micro AnchorMitek Products1996—
+1K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC2007—
+1K032078Mitek Micro QuickanchorMitek Worldwide2003—
+1K080352Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix AQ+…Depuy Mitek, A Johnson & Johnson Company2008—
+2K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc.2010—
+2K110879Biomet Sports Medicine Juggerknot (TM) Mini Soft AnchorBiomet Sports Medicine20112

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200710
200810
200910
201010
201120
201310
201430
201510
202010
202610
FIG. 1 — Lineage of K962793, 1996–2026Source: 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
*—Suture
Named without a submission number
—
†K915089Mitek Quickanchor (TM), ModificationMitek Surgical Products, Inc.1992—
†K930892Mitek Mini Anchor, ModificationMitek Surgical Products, Inc.1994—

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC20077
K032078Mitek Micro QuickanchorMitek Worldwide20035
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, K071520 (Core Essence Orthopaedics, LLC, 2007) has gone furthest, with 7 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—

What is it indicated for?

The device is used to anchor suture into bone. The suture is subsequently used by the surgeon to reattach the repositioned/injured soft tissue to bone. The purpose of this 510(k) submission is to obtain clearance for the Mitek Micro Anchor for the lateral canthoplasty and collateral ligament(s) around the (PIP) joint. The intended use is the same as the predicate device, i.e., suture, when used to approximate soft tissue to bone during a period of rehabilitation.

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

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 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/K962793 · printed Nov 5, 2026

Cite this page

510(k) Report. “K962793: Mitek Micro Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962793

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
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026