510(k) Report

510(k) · Cleared

Cleared

Opus Magnum Anchor & Inserter

K012125510(k) TraditionalCleared Sep 17, 200173-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. · HTY Pin, Fixation, Smooth

Cleared on Sep 17, 2001 after a 73-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 105 later devices descend from it.

Decided
Sep 17, 2001
Review
73 days
Class
Class II
Product code
HTY
Recalls
None
Predicates
0

105 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2007: 3 descendants cleared2004: 2 descendants cleared2002: 1 descendant cleared2009: 5 descendants cleared2006: 4 descendants cleared2008: 5 descendants cleared2010: 5 descendants cleared2012: 4 descendants cleared2011: 11 descendants cleared2013: 8 descendants cleared2018: 3 descendants cleared2017: 3 descendants cleared2015: 7 descendants cleared2019: 3 descendants cleared2014: 5 descendants cleared2020: 4 descendants cleared2025: 7 descendants cleared2022: 4 descendants cleared2021: 1 descendant cleared2023: 10 descendants cleared2026: 7 descendants cleared2016: 1 descendant cleared2024: 2 descendants cleared200020052010201520202025
  1. This deviceK012125 Opus Magnum Anchor & InserterOpus Medical, Inc. · 2001
  2. Descendant · cites it directly · 55 of its ownK042914 Opus Magnum Knotless Anchor with Inserter HandleOpus Medical, Inc. · 2004
  3. Descendant · cites it directly · 52 of its ownK042584 Opus Minimagnum Anchor with InserterOpus Medical, Inc. · 2004 · Recalled
  4. Descendant · 2 generations on · 50 of its ownK061349 Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006
  5. Descendant · 2 generations on · 33 of its ownK060914 Trident AnchorJohnson & Johnson Company · 2006
  6. Descendant · 3 generations on · 32 of its ownK063478 Versalok Anchor with Free Strands of Orthocord Suture (210808)…Depuy Mitek, A Johnson & Johnson Company · 2006

Showing 5 of 105 descendants. See all descendants

Descendants cleared per year

2002: 12004: 22006: 42007: 32008: 52009: 52010: 52011: 112012: 42013: 82014: 52015: 72016: 12017: 32018: 32019: 32020: 42021: 12022: 42023: 102024: 22025: 72026: 7
2002high 11 (2011) · low 0 (2003)2026

Most influential descendants

Showing 5 of 105 · See all
  • K042914Opus Magnum Knotless Anchor with Inserter HandleOpus Medical, Inc. · 2004 · cites it directly55descendants
  • K042584Opus Minimagnum Anchor with InserterOpus Medical, Inc. · 2004 · cites it directly52descendants
  • K061349Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006 · 2 generations on50descendants
  • K060914Trident AnchorJohnson & Johnson Company · 2006 · 2 generations on33descendants
  • K063478Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond Suture…Depuy Mitek, A Johnson & Johnson Company · 2006 · 3 generations on32descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K012125Opus Magnum Anchor & InserterOpus Medical, Inc.2001—
+1K042914Opus Magnum Knotless Anchor with Inserter HandleOpus Medical, Inc.2004—
+1K042584Opus Minimagnum Anchor with InserterOpus Medical, Inc.20043
+2K061349Opus Labralock P Knotless Fixation DeviceArthrocare Corp.2006—
+2K060914Trident AnchorJohnson & Johnson Company2006—
+3K063478Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond…Depuy Mitek, A Johnson & Johnson Company2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200420
200640
200730
200850
200950
201050
2011110
201240
201380
201450
201570
201610
201730
201830
201930
202040
202110
202240
2023100
202420
202570
202670
FIG. 1 — Lineage of K012125, 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HTY? 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 HTY device

  1. #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (105)

See all 105

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

NumberDeviceApplicantDecidedDescendants
K042914Opus Magnum Knotless Anchor with Inserter HandleOpus Medical, Inc.200455
K042584Opus Minimagnum Anchor with InserterOpus Medical, Inc.200452
K070227Opus Magnum PI Knotless Fixation DeviceArthrocare Corp.200727
K020172Opus Magnum Anchor & Instrument SetOpus Medical, Inc.20020

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, K042914 (Opus Medical, Inc., 2004) has gone furthest, with 55 descendants of its own.

How does its category compare?

All HTY devices

HTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HTY

5in 2025

2007: 62008: 62009: 22010: 92011: 62012: 42013: 42014: 82015: 82016: 62017: 52018: 42019: 42020: 52021: 52022: 42023: 52024: 12025: 52026 (partial year): 2
2007high 9 (2010) · low 1 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HTY

90in 2025

2007: 112 days median2008: 86 days median2010: 180 days median2011: 82 days median2012: 76 days median2013: 128 days median2014: 73 days median2015: 101 days median2016: 114 days median2017: 127 days median2018: 162 days median2019: 93 days median2020: 108 days median2021: 137 days median2022: 121 days median2023: 146 days median2025: 90 days median
2007high 180 (2010) · low 73 (2014)2026

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

Recalls per year · HTY

2in 2022

2009: 12010: 12016: 22019: 12022: 22026 (partial year): 1
2007high 2 (2016) · low 0 (2007)2026

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

Adverse event reports per year · HTY

39in 2025

2007: 462008: 382009: 362010: 332011: 1642012: 1292013: 1872014: 1492015: 1212016: 1282017: 822018: 1382019: 2222020: 2102021: 1482022: 962023: 1532024: 2972025: 39
2007high 297 (2024) · low 33 (2010)2025

MAUDE reports naming product code HTY, 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
20076112046
2008686038
20092—136
20109180133
20116820164
20124760129
201341280187
20148730149
201581010121
201661142128
20175127082
201841620138
20194931222
202051080210
202151370148
20224121296
202351460153
20241—0297
2025590039
20262—1—

What is it indicated for?

The Opus Magnum Anchor and Inserter is intended for the fixation of soft tissue to bone for the following indications:

Q) SHOULDER

1.) Rotator Cuff Repair

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Opus Medical, Inc.

13 FDA decisions under this applicant name. See the company

  • K042584Opus Minimagnum Anchor with InserterOpus Medical, Inc. · 20043 recalls
  • 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

Recent decisions in HTY

The HTY category page

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https://510kreport.com/device/K012125 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012125: Opus Magnum Anchor & Inserter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012125

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026