510(k) Report

510(k) · Cleared

Cleared

Mitek Anchor, Mitek Anchor II

K920213510(k) TraditionalCleared May 1, 1992106-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 Surgical Products, Inc. · JDR Staple, Fixation, Bone

Cleared on May 1, 1992 after a 106-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 109 later devices descend from it.

Decided
May 1, 1992
Review
106 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
0

109 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 1997: 4 descendants cleared1996: 5 descendants cleared1998: 2 descendants cleared1999: 4 descendants cleared2010: 5 descendants cleared2001: 2 descendants cleared2004: 1 descendant cleared2013: 4 descendants cleared2012: 8 descendants cleared2002: 2 descendants cleared2014: 4 descendants cleared2019: 7 descendants cleared2009: 2 descendants cleared2017: 7 descendants cleared2018: 6 descendants cleared2011: 5 descendants cleared2023: 10 descendants cleared2020: 6 descendants cleared2006: 2 descendants cleared2008: 1 descendant cleared2026: 2 descendants cleared2022: 3 descendants cleared2021: 4 descendants cleared2016: 1 descendant cleared2015: 1 descendant cleared2025: 8 descendants cleared2024: 3 descendants cleared1990200020102020
  1. This deviceK920213 Mitek Anchor, Mitek Anchor IIMitek Surgical Products, Inc. · 1992
  2. Descendant · cites it directly · 61 of its ownK960825 LM Anchor or Other Proprietary NameLi Medical Technologies, Inc. · 1996
  3. Descendant · cites it directly · 60 of its ownK960439 LM Bone AnchorLi Medical Technologies, Inc. · 1996
  4. Descendant · 2 generations on · 58 of its ownK963812 LM Bone Anchor (Orthopedics)Li Medical Technologies, Inc. · 1996
  5. Descendant · 3 generations on · 56 of its ownK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
  6. Descendant · cites it directly · 44 of its ownK962372 Urotac Bone Anchor InserterInfluence, Inc. · 1996

Showing 5 of 109 descendants. See all descendants

Descendants cleared per year

1996: 51997: 41998: 21999: 42001: 22002: 22004: 12006: 22008: 12009: 22010: 52011: 52012: 82013: 42014: 42015: 12016: 12017: 72018: 62019: 72020: 62021: 42022: 32023: 102024: 32025: 82026: 2
1996high 10 (2023) · low 0 (2000)2026

Most influential descendants

Showing 5 of 109 · See all
  • K960825LM Anchor or Other Proprietary NameLi Medical Technologies, Inc. · 1996 · cites it directly61descendants
  • K960439LM Bone AnchorLi Medical Technologies, Inc. · 1996 · cites it directly60descendants
  • K963812LM Bone Anchor (Orthopedics)Li Medical Technologies, Inc. · 1996 · 2 generations on58descendants
  • K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · 3 generations on56descendants
  • K962372Urotac Bone Anchor InserterInfluence, Inc. · 1996 · cites it directly44descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K920213Mitek Anchor, Mitek Anchor IIMitek Surgical Products, Inc.1992—
+1K960825LM Anchor or Other Proprietary NameLi Medical Technologies, Inc.1996—
+1K960439LM Bone AnchorLi Medical Technologies, Inc.1996—
+2K963812LM Bone Anchor (Orthopedics)Li Medical Technologies, Inc.1996—
+3K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp.20091
+1K962372Urotac Bone Anchor InserterInfluence, Inc.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199650
199740
199820
199940
200120
200220
200410
200620
200810
200920
201050
201150
201280
201340
201440
201510
201610
201770
201860
201970
202060
202140
202230
2023100
202430
202580
202620
FIG. 1 — Lineage of K920213, 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (109)

See all 109

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

NumberDeviceApplicantDecidedDescendants
K960825LM Anchor or Other Proprietary NameLi Medical Technologies, Inc.199661
K960439LM Bone AnchorLi Medical Technologies, Inc.199660
K962372Urotac Bone Anchor InserterInfluence, Inc.199644
K970292IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone ScrewInfluence, Inc.199740
K972023Sleep-in Bone Screw SystemInfluence, Inc.199723
K981677Repose Bone Screw SystemInfluence, Inc.199916
K980595Depuy Orthotech Catera Suture AnchorDePuy Orthopaedics, Inc.19980

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, K960825 (Li Medical Technologies, Inc., 1996) has gone furthest, with 61 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—

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 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/K920213 · printed Nov 6, 2026

Cite this page

510(k) Report. “K920213: Mitek Anchor, Mitek Anchor II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920213

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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