# K041589: Arthrex Fiberwire with Silk

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Aug 5, 2004 after 55 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: 3 generations back to K990088 (1999). 11 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021434: Arthrex Fiberwire in Usp Sizes, Arthrex, Inc. (2002) Summary page 1.
- K012124: Mersilk Black Silk Braided Non-Absorbable Suture, Usp, Johnson & Johnson Medical (China), Ltd. (2001) Summary page 1.
- K024091: Silk Sutures, Aurolab (2003) Summary page 1.

## Most influential descendants
- K071622: Arthrex Fiberwire (2007), 3 descendants of its own
- K252225: PowerKnot High Strength Sutures (2025), 0 descendants of its own
- K123668: Orthocord (2013), 0 descendants of its own
- K080918: Double Armed Meniscal Needles with Size #2-0 Orthocord, Meniscal Needle with Wire Eyelet & 3 Free Strands of Size #2-0 (2008), 0 descendants of its own

## Indications for use
The Arthrex FiberwireTM and FiberTape MT Families are intended for use in soft tissue approximation and/or ligation including allograft tissue.

Source page: https://510kreport.com/device/K041589
Methodology: https://510kreport.com/methodology