510(k) Report

510(k) · Cleared

Cleared

Mitek Gii Anchor

K953877510(k) TraditionalCleared Dec 29, 1995165-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 Surgical Products, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Dec 29, 1995 after a 165-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 572 later devices descend from it.

Decided
Dec 29, 1995
Review
165 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
0

572 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1997: 4 descendants cleared1998: 3 descendants cleared2003: 3 descendants cleared2001: 2 descendants cleared2004: 9 descendants cleared2008: 11 descendants cleared2007: 10 descendants cleared2006: 9 descendants cleared2002: 4 descendants cleared2005: 6 descendants cleared2010: 8 descendants cleared2011: 19 descendants cleared2016: 14 descendants cleared2020: 35 descendants cleared2009: 12 descendants cleared1999: 4 descendants cleared2014: 26 descendants cleared2013: 19 descendants cleared2017: 26 descendants cleared2012: 10 descendants cleared2025: 55 descendants cleared2024: 50 descendants cleared2022: 34 descendants cleared2015: 15 descendants cleared2019: 34 descendants cleared2018: 20 descendants cleared2023: 46 descendants cleared2026: 52 descendants cleared2021: 31 descendants cleared1995200020052010201520202025
  1. This deviceK953877 Mitek Gii AnchorMitek Surgical Products, Inc. · 1995
  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 572 descendants. See all descendants

Descendants cleared per year

1996: 11997: 41998: 31999: 42001: 22002: 42003: 32004: 92005: 62006: 92007: 102008: 112009: 122010: 82011: 192012: 102013: 192014: 262015: 152016: 142017: 262018: 202019: 342020: 352021: 312022: 342023: 462024: 502025: 552026: 52
1996high 55 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 572 · 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)K953877Mitek Gii AnchorMitek Surgical Products, Inc.1995—
+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
199610
199740
199830
199940
200120
200240
200330
200490
200560
200690
2007100
2008110
2009120
201080
2011190
2012100
2013190
2014260
2015150
2016140
2017260
2018200
2019340
2020350
2021310
2022340
2023460
2024500
2025550
2026520
FIG. 1 — Lineage of K953877, 1995–2026Source: 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 MBI? 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 MBI device

  1. #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (572)

See all 572

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

NumberDeviceApplicantDecidedDescendants
K962397Statak Soft Tissue Attachment DeviceZimmer, Inc.1996531
K972783Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc.1998166
K012572Soft Tissue Screw and WasherBiomet, Inc.200147
K023963Adhoc ClawFuture Medical Systems, Inc.20031
K980103Acumed Suture AnchorAcu Med, Inc.19980
K973281The Surgical Dynamics* S.D. Sorb* E-Z Tac*United States Surgical, A Division of Tyco Healthc19970
K971144Multitak SS Suture SystemBonutti Research19970
K964324Multitak SS Suture SystemBonutti Research19970

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 MBI devices

MBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MBI

27in 2025

2007: 162008: 102009: 192010: 172011: 302012: 242013: 312014: 232015: 232016: 172017: 172018: 162019: 312020: 352021: 182022: 192023: 522024: 222025: 272026 (partial year): 30
2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007: 80 days median2008: 69 days median2009: 82 days median2010: 76 days median2011: 75 days median2012: 94 days median2013: 100 days median2014: 101 days median2015: 85 days median2016: 94 days median2017: 70 days median2018: 91 days median2019: 90 days median2020: 83 days median2021: 107 days median2022: 64 days median2023: 57 days median2024: 30 days median2025: 58 days median2026 (partial year): 63 days median
2007high 107 (2021) · low 30 (2024)2026

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

Recalls per year · MBI

1in 2025

2007: 242008: 62009: 22010: 32011: 232012: 62013: 22017: 42018: 22020: 12023: 12024: 12025: 1
2007high 24 (2007) · low 0 (2014)2026

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

Adverse event reports per year · MBI

3,826in 2025

2007: 2402008: 3382009: 3552010: 2912011: 3282012: 3712013: 4422014: 5042015: 5072016: 7952017: 6752018: 1,0722019: 1,3032020: 1,4542021: 1,8902022: 1,5912023: 2,5032024: 3,7792025: 3,826
2007high 3,826 (2025) · low 240 (2007)2025

MAUDE reports naming product code MBI, 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
2007168024240
200810696338
200919822355
201017763291
2011307523328
201224946371
2013311002442
2014231010504
201523850507
201617940795
201717704675
2018169121,072
2019319001,303
2020358311,454
20211810701,890
2022196401,591
2023525712,503
2024223013,779
2025275813,826
202630630—

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
  • K936311Mitek Mini AnchorMitek Surgical Products, Inc. · 1995
  • K941599Mitek Absorbable AnchorMitek Surgical Products, Inc. · 1995
  • K944051Absorbalbe AnchorMitek Surgical Products, Inc. · 1995
  • K950070Mitek Toggle Anchor (TM)Mitek Surgical Products, Inc. · 1995

Recent decisions in MBI

The MBI category page

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K263352TeKBrace Knotless AnchorTheraMicro · 2026
  • K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc. · 2026
  • K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc. · 2026
  • K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026

https://510kreport.com/device/K953877 · printed Nov 6, 2026

Cite this page

510(k) Report. “K953877: Mitek Gii Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953877

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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