# K001434: 'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Surgical Product (Genzyme Biosurgery)
- Decided: Jun 12, 2000 after 35 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
274 later devices descend from it; 7 cite it directly.
0 of 275 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012923: Arthrex Fiberwire, Usp Size 5, Model AR-7201 (2001), 260 descendants of its own
- K021434: Arthrex Fiberwire in Usp Sizes (2002), 259 descendants of its own
- K031666: Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS (2003), 161 descendants of its own
- K062747: Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM (2006), 143 descendants of its own
- K063778: Force Fiber Polyethylene Nonabsorbable Suture (2007), 69 descendants of its own

## Recalls of this device
- Jun 6, 2007 · Not classified · Z-1017-2007: Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

Source page: https://510kreport.com/device/K001434
Methodology: https://510kreport.com/methodology