510(k) Report

510(k) · Cleared

Recalled · 2011

Opus Minimagnum Anchor with Inserter

K042584510(k) TraditionalCleared Dec 14, 200483-day reviewClass II21 CFR 888.3040Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Opus Medical, Inc. · HWC Screw, Fixation, Bone

Cleared on Dec 14, 2004 as substantially equivalent to K012125 (Opus Medical, Inc., 2001) after an 83-day review. Its family tree reaches back 1 generation to 2001. 52 later devices descend from it. It has been recalled 3 times.

Decided
Dec 14, 2004
Review
83 days
Class
Class II
Product code
HWC
Recalls
3
Predicates
1

Its longest line of descent runs back 1 generation to K012125 (2001). 52 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2009: 4 descendants cleared2006: 1 descendant cleared2007: 2 descendants cleared2012: 3 descendants cleared2011: 8 descendants cleared2008: 2 descendants cleared2010: 4 descendants cleared2015: 7 descendants cleared2013: 6 descendants cleared2019: 1 descendant cleared2017: 2 descendants cleared2014: 3 descendants cleared2020: 3 descendants cleared2025: 2 descendants cleared2022: 1 descendant cleared2026: 2 descendants cleared2016: 1 descendant clearedK012125 · Opus Magnum Anchor & Inserter · Opus Medical, Inc. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 7 descendants4 generations forward: 10 descendants5 generations forward: 19 descendants6 generations forward: 7 descendants7 generations forward: 2 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 deviceK042584 Opus Minimagnum Anchor with InserterOpus Medical, Inc. · 2004
  3. Descendant · cites it directly · 50 of its ownK061349 Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006
  4. Descendant · 2 generations on · 27 of its ownK070227 Opus Magnum PI Knotless Fixation DeviceArthrocare Corp. · 2007
  5. Descendant · 2 generations on · 18 of its ownK090615 Opus Speedlock Knotless Fixation DeviceArthrocare Corp. · 2009 · Recalled
  6. Descendant · 3 generations on · 16 of its ownK081893 Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500Arthrocare Corp. · 2008
  7. Descendant · 4 generations on · 15 of its ownK100457 Opus Speedscrew SystemArthrocare Corp. · 2010

Showing 5 of 52 descendants. See all descendants

Descendants cleared per year

2006: 12007: 22008: 22009: 42010: 42011: 82012: 32013: 62014: 32015: 72016: 12017: 22019: 12020: 32022: 12025: 22026: 2
2006high 8 (2011) · low 0 (2018)2026

Most influential descendants

Showing 5 of 52 · See all
  • K061349Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006 · cites it directly50descendants
  • K070227Opus Magnum PI Knotless Fixation DeviceArthrocare Corp. · 2007 · 2 generations on27descendants
  • K090615Opus Speedlock Knotless Fixation DeviceArthrocare Corp. · 2009 · 2 generations on18descendants
  • K081893Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500Arthrocare Corp. · 2008 · 3 generations on16descendants
  • K100457Opus Speedscrew SystemArthrocare Corp. · 2010 · 4 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K012125Opus Magnum Anchor & InserterOpus Medical, Inc.2001—
0 (this device)K042584Opus Minimagnum Anchor with InserterOpus Medical, Inc.2004—
+1K061349Opus Labralock P Knotless Fixation DeviceArthrocare Corp.2006—
+2K070227Opus Magnum PI Knotless Fixation DeviceArthrocare Corp.2007—
+2K090615Opus Speedlock Knotless Fixation DeviceArthrocare Corp.20091
+3K081893Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500Arthrocare Corp.2008—
+4K100457Opus Speedscrew SystemArthrocare Corp.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200720
200820
200940
201040
201180
201230
201360
201430
201570
201610
201720
201910
202030
202210
202520
202620
FIG. 1 — Lineage of K042584, 2001–2026Source: 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), 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 HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 14 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? (2)

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 & Inserter
Summary page 2
…mplant System. The MiniMagnum" The intended use and Magnum TM originally cleared under 510(k) 012125, but is smaller in size. Bone Anchor. indicatio…
Opus Medical, Inc.2001—
*—Mitek BioKnotless Anchor
Named without a submission number
—

Also cleared against K012125: 3 other devices →

What descends from it? (52)

See all 52

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

NumberDeviceApplicantDecidedDescendants
K061349Opus Labralock P Knotless Fixation DeviceArthrocare Corp.200650
K083240Opus MAGNUM2 and Opus Magnum X Knotless Fixation DevicesArthrocare Corp.20090
K071374Opus Twinlock Knotless Fixation DeviceArthrocare Corp.20070

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 8, 2011Not classifiedZ-0627-2012Reprocessing ControlsProduct is being removed from the field due to an over-label issue.
Aug 8, 2011Not classifiedZ-0628-2012Reprocessing ControlsProduct is being removed from the field due to an over-label issue.
May 11, 2011Not classifiedZ-0049-2012Packaging process controlArthroCare initiated the recall of one lot of the MiniMagnum Knotless Implant Fixation Device where the incorrect diver block was packed with the implant.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K061349 (Arthrocare Corp., 2006) has gone furthest, with 50 descendants of its own.
  • 3 other devices also cite its predicate K012125.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The Opus MiniMagnum bone anchor with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction Foot: Hallux valgus…

Read the full statement (93 words)

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

Examples of such procedures include:

Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair

Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon reattachment

Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

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
  • K042914Opus Magnum Knotless Anchor with Inserter HandleOpus Medical, Inc. · 2004
  • K020172Opus Magnum Anchor & Instrument SetOpus Medical, Inc. · 2002

More from Opus Medical, Inc.

13 FDA decisions under this applicant name. See the company

  • K042914Opus Magnum Knotless Anchor with Inserter HandleOpus Medical, Inc. · 2004
  • 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 HWC

The HWC category page

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  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K042584 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042584: Opus Minimagnum Anchor with Inserter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042584

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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