510(k) Report

510(k) · Cleared

Cleared

Quickanchor, Modification

K921873510(k) TraditionalCleared Jun 9, 199262-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 Jun 9, 1992 after a 62-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 125 later devices descend from it.

Decided
Jun 9, 1992
Review
62 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
0

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

Descendants, by year cleared 1999: 2 descendants cleared1996: 3 descendants cleared2007: 3 descendants cleared2003: 1 descendant cleared2006: 1 descendant cleared2014: 6 descendants cleared2011: 11 descendants cleared2019: 7 descendants cleared2020: 6 descendants cleared2016: 3 descendants cleared2013: 10 descendants cleared2009: 5 descendants cleared2012: 7 descendants cleared2021: 3 descendants cleared2015: 9 descendants cleared2026: 5 descendants cleared2001: 1 descendant cleared2008: 2 descendants cleared2010: 5 descendants cleared2017: 9 descendants cleared2018: 4 descendants cleared2023: 8 descendants cleared2022: 3 descendants cleared2024: 3 descendants cleared2025: 8 descendants cleared1990200020102020
  1. This deviceK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
  2. Descendant · cites it directly · 67 of its ownK992487 Mitek Mini Quickanchor PlusMitek Products · 1999
  3. Descendant · cites it directly · 60 of its ownK960448 LM 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 · 2 generations on · 50 of its ownK061349 Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006

Showing 5 of 125 descendants. See all descendants

Descendants cleared per year

1996: 31999: 22001: 12003: 12006: 12007: 32008: 22009: 52010: 52011: 112012: 72013: 102014: 62015: 92016: 32017: 92018: 42019: 72020: 62021: 32022: 32023: 82024: 32025: 82026: 5
1996high 11 (2011) · low 0 (1997)2026

Most influential descendants

Showing 5 of 125 · See all
  • K992487Mitek Mini Quickanchor PlusMitek Products · 1999 · cites it directly67descendants
  • K960448LM 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
  • K061349Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006 · 2 generations on50descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K921873Quickanchor, ModificationMitek Surgical Products, Inc.1992—
+1K992487Mitek Mini Quickanchor PlusMitek Products1999—
+1K960448LM AnchorLi Medical Technologies, Inc.1996—
+2K963812LM Bone Anchor (Orthopedics)Li Medical Technologies, Inc.1996—
+3K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp.20091
+2K061349Opus Labralock P Knotless Fixation DeviceArthrocare Corp.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199630
199920
200110
200310
200610
200730
200820
200950
201050
2011110
201270
2013100
201460
201590
201630
201790
201840
201970
202060
202130
202230
202380
202430
202580
202650
FIG. 1 — Lineage of K921873, 1992–2026Source: 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), 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
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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? (125)

See all 125

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

NumberDeviceApplicantDecidedDescendants
K992487Mitek Mini Quickanchor PlusMitek Products199967
K960448LM AnchorLi Medical Technologies, Inc.199660
K992623Mitek Mini AnchorMitek Products199914

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, K992487 (Mitek Products, 1999) has gone furthest, with 67 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—
Cite this page

510(k) Report. “K921873: Quickanchor, Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921873

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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