# K003590: Grams Polyester Nonabsorbable Suture

- Pathway: 510(k) (Traditional)
- Applicant: Gramsmed, LLC
- Decided: Mar 5, 2001 after 104 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
281 later devices descend from it; 4 cite it directly.
0 of 282 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

Source page: https://510kreport.com/device/K003590
Methodology: https://510kreport.com/methodology