# K021434: Arthrex Fiberwire in Usp Sizes

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Nov 7, 2002 after 185 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
Longest line of descent: 2 generations back to K990088 (1999). 7 ancestors in all.
259 later devices descend from it; 11 cite it directly.
0 of 267 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010673: Arthrex Fiberwire, Model Spu-02NB-3800, Arthrex, Inc. (2001)
- K012923: Arthrex Fiberwire, Usp Size 5, Model AR-7201, Arthrex, Inc. (2001) Summary page 1.
- K003590: Grams Polyester Nonabsorbable Suture, Gramsmed, LLC (2001)
- K000540: Polyester Nonabsorbable Surgical Sutures, Usp, Arc Medical Supplies (Beijing) Co, Ltd. (2000) Summary page 1.
- K001434: 'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical Suture, Genzyme Surgical Product (Genzyme Biosurgery) (2000)

## Most influential descendants
- 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
- K100652: Acl Tightrope (2010), 65 descendants of its own
- K123341: Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex Proximal Biceps Button (2012), 52 descendants of its own

## Indications for use
FiberwireTMUSP sizes are intended for use in approximation or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.

Source page: https://510kreport.com/device/K021434
Methodology: https://510kreport.com/methodology