510(k) · Cleared
Recalled · Class II · 2013Blue Orthocord Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek · NEW Suture, Surgical, Absorbable, Polydioxanone
Cleared on Dec 10, 2004 as substantially equivalent to K040004 (Depuy Mitek, 2004) after a 10-day review. Its family tree reaches back 2 generations to 2001. 33 later devices descend from it. It has been recalled 6 times.
- Decided
- Dec 10, 2004
- Review
- 10 days
- Class
- Class II
- Product code
- NEW
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010673 (2001). 33 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK010673 Arthrex Fiberwire, Model Spu-02NB-3800Arthrex, Inc. · 2001
- 1 generation backK040004 Orthocord SutureDepuy Mitek · 2004 · Recalled
- This deviceK043298 Blue Orthocord SutureDepuy Mitek · 2004
- Descendant · cites it directly · 21 of its ownK082282 Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co. · 2008
- Descendant · 2 generations on · 15 of its ownK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011
- Descendant · cites it directly · 8 of its ownK071257 Mini Quickanchor and Quickanchor Plus with OrthocordDepuy Mitek, A Johnson & Johnson Company · 2007
- Descendant · 3 generations on · 6 of its ownK211002 Grappler Suture Anchor SystemParagon 28, Inc. · 2021 · Recalled
- Descendant · 3 generations on · 6 of its ownK103712 Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K082282Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co. · 2008 · cites it directly21descendants
- K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company · 2011 · 2 generations on15descendants
- K071257Mini Quickanchor and Quickanchor Plus with OrthocordDepuy Mitek, A Johnson & Johnson Company · 2007 · cites it directly8descendants
- K211002Grappler Suture Anchor SystemParagon 28, Inc. · 2021 · 3 generations on6descendants
- K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010673 | Arthrex Fiberwire, Model Spu-02NB-3800 | Arthrex, Inc. | 2001 | — |
| −1 | K040004 | Orthocord Suture | Depuy Mitek | 2004 | 1 |
| 0 (this device) | K043298 | Blue Orthocord Suture | Depuy Mitek | 2004 | — |
| +1 | K082282 | Healix TI Anchor | Depuy Mitek, A Johnson & Johnson Co. | 2008 | — |
| +2 | K102298 | Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend… | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| +1 | K071257 | Mini Quickanchor and Quickanchor Plus with Orthocord | Depuy Mitek, A Johnson & Johnson Company | 2007 | — |
| +3 | K211002 | Grappler Suture Anchor System | Paragon 28, Inc. | 2021 | 1 |
| +3 | K103712 | Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 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 NEW? 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 NEW device
- #1 K252047 STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue…score 15.3 · 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040004 | Orthocord SutureSummary page 1…Blue ORTHOCORD suture Substantial Equivalence Blue ORTHOCORD suture is substantially equivalent to: Violet ORTHOCORD suture (K040004) manufactured by Mitek; and PDS II suture (N18331) manufactured by Ethicon, Inc. Device Classi… | 2004 |
| Kept off the family tree | K018331 | PDS II suture Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (33)
See all 335 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 22, 2013 | Class II | Z-1172-2013 | Labeling Change Control | The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate… |
| Mar 22, 2013 | Class II | Z-1175-2013 | Labeling Change Control | The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate… |
| Mar 22, 2013 | Class II | Z-1174-2013 | Labeling Change Control | The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate… |
| Mar 22, 2013 | Class II | Z-1176-2013 | Labeling Change Control | The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate… |
| Mar 22, 2013 | Class II | Z-1173-2013 | Labeling Change Control | The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate… |
| Feb 2, 2009 | Not classified | Z-1315-2009 | Process control | Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K082282 (Depuy Mitek, A Johnson & Johnson Co., 2008) has gone furthest, with 21 descendants of its own.
- 9 other devices also cite its predicate K040004.
How does its category compare?
All NEW devicesNEW Suture, Surgical, Absorbable, Polydioxanone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NEW
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEW
146in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEW
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NEW
2,504in 2025
MAUDE reports naming product code NEW, 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 | 2 | — | 0 | 7 |
| 2008 | 5 | 22 | 1 | 29 |
| 2009 | 0 | — | 4 | 42 |
| 2010 | 3 | 270 | 0 | 115 |
| 2011 | 1 | — | 0 | 59 |
| 2012 | 3 | 113 | 1 | 82 |
| 2013 | 5 | 32 | 1 | 185 |
| 2014 | 1 | — | 1 | 274 |
| 2015 | 2 | — | 0 | 280 |
| 2016 | 3 | 254 | 0 | 321 |
| 2017 | 1 | — | 0 | 461 |
| 2018 | 3 | 441 | 0 | 900 |
| 2019 | 4 | 144 | 2 | 1,122 |
| 2020 | 3 | 230 | 0 | 1,010 |
| 2021 | 1 | — | 0 | 1,466 |
| 2022 | 1 | — | 1 | 1,537 |
| 2023 | 1 | — | 0 | 1,975 |
| 2024 | 3 | 48 | 0 | 2,114 |
| 2025 | 6 | 146 | 0 | 2,504 |
| 2026 | 5 | 264 | 0 | — |
What is it indicated for?
Blue ORTHOCORD suture is indicated for use in general soft tissue approximation and/or ligation, including use in orthopedic surgeries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043298 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043298: Blue Orthocord Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043298
Report an extraction error
Are you the manufacturer?
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