# K043298: Blue Orthocord Suture

- Pathway: 510(k) (Special)
- Applicant: Depuy Mitek
- Decided: Dec 10, 2004 after 10 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010673 (2001). 2 ancestors in all.
33 later devices descend from it; 5 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040004: Orthocord Suture, Depuy Mitek (2004) Summary page 1.

## Cited in the summary but 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

## Most influential descendants
- K082282: Healix TI Anchor (2008), 21 descendants of its own
- K102298: Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor W/Orthocord, Healix Transtend (2011), 15 descendants of its own
- K071257: Mini Quickanchor and Quickanchor Plus with Orthocord (2007), 8 descendants of its own
- K211002: Grappler Suture Anchor System (2021), 6 descendants of its own
- K103712: Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord (2011), 6 descendants of its own

## Recalls of this device
- Mar 22, 2013 · Class II · Z-1172-2013: 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 ORT
- Mar 22, 2013 · Class II · Z-1175-2013: 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 ORT
- Mar 22, 2013 · Class II · Z-1174-2013: 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 ORT
- Mar 22, 2013 · Class II · Z-1176-2013: 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 ORT
- Mar 22, 2013 · Class II · Z-1173-2013: 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 ORT
- Feb 2, 2009 · Not classified · Z-1315-2009: 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.

## Indications for use
Blue ORTHOCORD suture is indicated for use in general soft tissue approximation and/or ligation, including use in orthopedic surgeries.

Source page: https://510kreport.com/device/K043298
Methodology: https://510kreport.com/methodology