510(k) Report

510(k) · Cleared

Cleared

Opus Magnum Knotless Anchor with Inserter Handle

K042914510(k) SpecialCleared Nov 12, 200422-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

Opus Medical, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Nov 12, 2004 as substantially equivalent to K012125 (Opus Medical, Inc., 2001) after a 22-day review. Its family tree reaches back 1 generation to 2001. 55 later devices descend from it.

Decided
Nov 12, 2004
Review
22 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K012125 (2001). 55 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2008: 3 descendants cleared2006: 3 descendants cleared2010: 1 descendant cleared2007: 1 descendant cleared2009: 1 descendant cleared2018: 3 descendants cleared2017: 1 descendant cleared2011: 3 descendants cleared2012: 1 descendant cleared2019: 3 descendants cleared2020: 2 descendants cleared2025: 7 descendants cleared2021: 1 descendant cleared2022: 4 descendants cleared2023: 10 descendants cleared2026: 5 descendants cleared2014: 2 descendants cleared2013: 2 descendants cleared2024: 2 descendants clearedK012125 · Opus Magnum Anchor & Inserter · Opus Medical, Inc. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 5 descendants4 generations forward: 6 descendants5 generations forward: 15 descendants6 generations forward: 18 descendants7 generations forward: 5 descendants K012125 · Opus Magnum Anchor & Inserter · Opus Medical, Inc. · 20010+5
  1. Root · 1 generation backK012125 Opus Magnum Anchor & InserterOpus Medical, Inc. · 2001
  2. This deviceK042914 Opus Magnum Knotless Anchor with Inserter HandleOpus Medical, Inc. · 2004
  3. Descendant · cites it directly · 33 of its ownK060914 Trident AnchorJohnson & Johnson Company · 2006
  4. Descendant · 2 generations on · 32 of its ownK063478 Versalok Anchor with Free Strands of Orthocord Suture (210808)…Depuy Mitek, A Johnson & Johnson Company · 2006
  5. Descendant · 3 generations on · 27 of its ownK171020 Arthrex Knotless SutureTak AnchorArthrex, Inc. · 2017
  6. Descendant · cites it directly · 19 of its ownK061294 KFX Knotless Fixation SystemKfx Medical · 2006
  7. Descendant · 2 generations on · 18 of its ownK072063 KFX Tissue Fixation System and AccessoriesKfx Medical · 2007

Showing 5 of 55 descendants. See all descendants

Descendants cleared per year

2006: 32007: 12008: 32009: 12010: 12011: 32012: 12013: 22014: 22017: 12018: 32019: 32020: 22021: 12022: 42023: 102024: 22025: 72026: 5
2006high 10 (2023) · low 0 (2015)2026

Most influential descendants

Showing 5 of 55 · See all
  • K060914Trident AnchorJohnson & Johnson Company · 2006 · cites it directly33descendants
  • K063478Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond Suture…Depuy Mitek, A Johnson & Johnson Company · 2006 · 2 generations on32descendants
  • K171020Arthrex Knotless SutureTak AnchorArthrex, Inc. · 2017 · 3 generations on27descendants
  • K061294KFX Knotless Fixation SystemKfx Medical · 2006 · cites it directly19descendants
  • K072063KFX Tissue Fixation System and AccessoriesKfx Medical · 2007 · 2 generations on18descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K012125Opus Magnum Anchor & InserterOpus Medical, Inc.2001—
0 (this device)K042914Opus Magnum Knotless Anchor with Inserter HandleOpus Medical, Inc.2004—
+1K060914Trident AnchorJohnson & Johnson Company2006—
+2K063478Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond…Depuy Mitek, A Johnson & Johnson Company2006—
+3K171020Arthrex Knotless SutureTak AnchorArthrex, Inc.2017—
+1K061294KFX Knotless Fixation SystemKfx Medical2006—
+2K072063KFX Tissue Fixation System and AccessoriesKfx Medical2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200630
200710
200830
200910
201010
201130
201210
201320
201420
201710
201830
201930
202020
202110
202240
2023100
202420
202570
202650
FIG. 1 — Lineage of K042914, 2001–2026Source: 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 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? (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
*K012125Opus Magnum Anchor & InserterOpus Medical, Inc.2001—

Also cleared against K012125: 3 other devices →

What descends from it? (55)

See all 55

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

NumberDeviceApplicantDecidedDescendants
K060914Trident AnchorJohnson & Johnson Company200633
K061294KFX Knotless Fixation SystemKfx Medical200619
K081497Opus MAGNUM2 Knotless Fixation Device (Model OM-1502), Opus Magnum X Knotless Fixation…Arthrocare Corp.20080

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?

  • Its one ancestor has no recall.
  • Of its descendants, K060914 (Johnson & Johnson Company, 2006) has gone furthest, with 33 descendants of its own.
  • 3 other devices also cite its predicate K012125.

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—

What is it indicated for?

The Opus MagnumTM bone anchor with inserter is indicated for use in fixation of soft tissue to

bone for rotator cuff repair.

Indications for use as stated in the FDA summary.

Also cleared against K012125

3 other devices cite the same predicate.

  • K070227Opus Magnum PI Knotless Fixation DeviceArthrocare Corp. · 2007
  • K042584Opus Minimagnum Anchor with InserterOpus Medical, Inc. · 20043 recalls
  • K020172Opus Magnum Anchor & Instrument SetOpus Medical, Inc. · 2002

More from Opus Medical, Inc.

13 FDA decisions under this applicant name. See the company

  • K042584Opus Minimagnum Anchor with InserterOpus Medical, Inc. · 20043 recalls
  • K042031Opus Speedstitch Suture DeviceOpus Medical, Inc. · 20041 recall
  • K041440Opus Magnum Anchor with InserterOpus Medical, Inc. · 2004
  • K033317Smartstitch M-Connector, Model OM-8700; Needle Cassette, OM-8750; Autocuff System Instrument Set, OM-9070Opus Medical, Inc. · 2003
  • K030170Reusable Smartstitch Suture Device, Models OM-8007, OM-8500Opus Medical, Inc. · 2003

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/K042914 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042914: Opus Magnum Knotless Anchor with Inserter Handle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042914

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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