510(k) Report

510(k) · Cleared

Cleared

Mitek Bone Anchor, Modification

K915889510(k) TraditionalCleared Oct 22, 1992307-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 Oct 22, 1992 after a 307-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 80 later devices descend from it.

Decided
Oct 22, 1992
Review
307 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
0

80 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2011: 5 descendants cleared1996: 3 descendants cleared2012: 4 descendants cleared1999: 2 descendants cleared1998: 1 descendant cleared2005: 2 descendants cleared2014: 3 descendants cleared2007: 1 descendant cleared2009: 1 descendant cleared2001: 1 descendant cleared2017: 7 descendants cleared2018: 4 descendants cleared2010: 1 descendant cleared2023: 9 descendants cleared2019: 8 descendants cleared2015: 2 descendants cleared2021: 3 descendants cleared2013: 2 descendants cleared2026: 3 descendants cleared2022: 2 descendants cleared2016: 1 descendant cleared2020: 4 descendants cleared2025: 8 descendants cleared2024: 2 descendants cleared1990200020102020
  1. This deviceK915889 Mitek Bone Anchor, ModificationMitek Surgical Products, Inc. · 1992
  2. Descendant · cites it directly · 60 of its ownK960439 LM Bone AnchorLi Medical Technologies, Inc. · 1996
  3. Descendant · 2 generations on · 58 of its ownK963812 LM Bone Anchor (Orthopedics)Li Medical Technologies, Inc. · 1996
  4. Descendant · 3 generations on · 56 of its ownK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
  5. Descendant · 4 generations on · 29 of its ownK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
  6. Descendant · 5 generations on · 17 of its ownK131035 Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures…Linvatec Corporation D/B/A Conmed Linvatec · 2013

Showing 5 of 80 descendants. See all descendants

Descendants cleared per year

1996: 31998: 11999: 22001: 12004: 12005: 22007: 12009: 12010: 12011: 52012: 42013: 22014: 32015: 22016: 12017: 72018: 42019: 82020: 42021: 32022: 22023: 92024: 22025: 82026: 3
1996high 9 (2023) · low 0 (1997)2026

Most influential descendants

Showing 5 of 80 · See all
  • 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
  • K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011 · 4 generations on29descendants
  • K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec · 2013 · 5 generations on17descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K915889Mitek Bone Anchor, ModificationMitek Surgical Products, Inc.1992—
+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
+4K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec2011—
+5K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199630
199810
199920
200110
200410
200520
200710
200910
201010
201150
201240
201320
201430
201520
201610
201770
201840
201980
202040
202130
202220
202390
202420
202580
202630
FIG. 1 — Lineage of K915889, 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (80)

See all 80

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

NumberDeviceApplicantDecidedDescendants
K960439LM Bone AnchorLi Medical Technologies, Inc.199660
K041115Gii Quickanchor PlusDepuy Mitek, A Johnson & Johnson Company200414
K992611Mitek Rotator Cuff Quickanchor PlusMitek Products19994
K111631Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor, Rotator Cuff…Depuy Mitek, A Johnson & Johnson Company20111
K112417VariousDepuy Mitek, A Johnson & Johnson Company20120
K981755LM AnchorLi Medical Technologies, 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, K960439 (Li Medical Technologies, Inc., 1996) has gone furthest, with 60 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/K915889 · printed Nov 6, 2026

Cite this page

510(k) Report. “K915889: Mitek Bone Anchor, Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915889

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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