# K012923: Arthrex Fiberwire, Usp Size 5, Model AR-7201

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Oct 4, 2001 after 34 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: 1 generation back to K990088 (1999). 6 ancestors in all.
260 later devices descend from it; 4 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) Summary page 1.
- K003590: Grams Polyester Nonabsorbable Suture, Gramsmed, LLC (2001) Summary page 1.
- K990088: Synthofil Nonabsorbable Pet Surgical Suture, Aesculap, Inc. (1999) Summary page 1.
- 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) Summary page 1.
- K001172: Polyester Nonabsorbable Surgical Sutures Urp, Cp Medical (2000)

## Most influential descendants
- 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
- K100652: Acl Tightrope (2010), 65 descendants of its own

## Indications for use
The Arthrex Fiberwire™ USP size 5 suture is intended for use in soft tissue approximation and or ligation.

Source page: https://510kreport.com/device/K012923
Methodology: https://510kreport.com/methodology