510(k) · Cleared
ClearedTrident Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Company · HWC Screw, Fixation, Bone
Cleared on Jun 9, 2006 as substantially equivalent to K971922 (Innovasive Devices, Inc., 1997) and 2 other predicates after a 66-day review. Its family tree reaches back 2 generations to 2001. 33 later devices descend from it.
- Decided
- Jun 9, 2006
- Review
- 66 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K012125 (2001). 6 ancestors in all, the oldest K971723 (1997). 33 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK012125 Opus Magnum Anchor & InserterOpus Medical, Inc. · 2001
- 1 generation backK042914 Opus Magnum Knotless Anchor with Inserter HandleOpus Medical, Inc. · 2004
- This deviceK060914 Trident AnchorJohnson & Johnson Company · 2006
- Descendant · cites it directly · 32 of its ownK063478 Versalok Anchor with Free Strands of Orthocord Suture (210808)…Depuy Mitek, A Johnson & Johnson Company · 2006
- Descendant · 2 generations on · 27 of its ownK171020 Arthrex Knotless SutureTak AnchorArthrex, Inc. · 2017
- Descendant · 3 generations on · 16 of its ownK203268 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020
- Descendant · 4 generations on · 6 of its ownK230568 FiberTak Suture AnchorArthrex, Inc. · 2023
- Descendant · 5 generations on · 5 of its ownK231330 FiberTak® Suture AnchorArthrex, Inc. · 2023
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K063478Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond Suture…Depuy Mitek, A Johnson & Johnson Company · 2006 · cites it directly32descendants
- K171020Arthrex Knotless SutureTak AnchorArthrex, Inc. · 2017 · 2 generations on27descendants
- K203268Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020 · 3 generations on16descendants
- K230568FiberTak Suture AnchorArthrex, Inc. · 2023 · 4 generations on6descendants
- K231330FiberTak® Suture AnchorArthrex, Inc. · 2023 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K012125 | Opus Magnum Anchor & Inserter | Opus Medical, Inc. | 2001 | — |
| −1 | K042914 | Opus Magnum Knotless Anchor with Inserter Handle | Opus Medical, Inc. | 2004 | — |
| 0 (this device) | K060914 | Trident Anchor | Johnson & Johnson Company | 2006 | — |
| +1 | K063478 | Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond… | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| +2 | K171020 | Arthrex Knotless SutureTak Anchor | Arthrex, Inc. | 2017 | — |
| +3 | K203268 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2020 | — |
| +4 | K230568 | FiberTak Suture Anchor | Arthrex, Inc. | 2023 | — |
| +5 | K231330 | FiberTak® Suture Anchor | Arthrex, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 8 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 0 |
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 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K970089 | FDA’s K970089 is Innovasive 2.8MM and 3.5MM Roc LF Suture Bone Fastener Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1997 |
| * | K971922 | Innovasive 2.8MM and 3.5MM Roc EZ Suture Bone FastenerSummary page 1…: Trident Anchor Substantial Equivalence Trident Anchor is substanitially equivalent to: ROC EZ Fastener (K97C'1089 & 1K971922); the Artbrex Pushlock Anchor (KO051219) and I.he ArthroCare Opus Magnum Implant… | 1997 |
| * | K051219 | PushlockSummary page 1…is substanitially equivalent to: ROC EZ Fastener (K97C'1089 & 1K971922); the Artbrex Pushlock Anchor (KO051219) and I.he ArthroCare Opus Magnum Implant (K042914). Device Classification This devic… | 2005 |
| * | K042914 | Opus Magnum Knotless Anchor with Inserter HandleSummary page 1…r (K97C'1089 & 1K971922); the Artbrex Pushlock Anchor (KO051219) and I.he ArthroCare Opus Magnum Implant (K042914). Device Classification This device carries an JFDA product code MBI and HWC, and is… | 2004 |
What descends from it? (33)
See all 332 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K063478 (Depuy Mitek, A Johnson & Johnson Company, 2006) has gone furthest, with 32 descendants of its own.
- 2 other devices also cite its predicate K971922.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
Trident Anchor is indicated for use in the following:
Shoulder: Rotor Cuff Repair, Biceps Tenodesis
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Joint Capsule Closure
Elbow: Biceps Tendon Reattachment
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060914 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060914: Trident Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060914
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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