# K071622: Arthrex Fiberwire

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Jul 3, 2007 after 19 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: 5 generations back to K990088 (1999). 14 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041589: Arthrex Fiberwire with Silk, Arthrex, Inc. (2004) Summary page 1.
- K041553: Arthrex Suture Grafting Kit, Arthrex, Inc. (2004) Summary page 1.

## Most influential descendants
- 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 FiberWire® suture configurations are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.

Source page: https://510kreport.com/device/K071622
Methodology: https://510kreport.com/methodology