# K041553: Arthrex Suture Grafting Kit

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Dec 10, 2004 after 184 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: 4 generations back to K990088 (1999). 11 ancestors in all.
31 later devices descend from it; 10 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032245: Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape (TM), 4MM, Models AR-7237, AR-7238, AR-7239, Arthrex, Inc. (2004) Summary page 1.
- K021434: Arthrex Fiberwire in Usp Sizes, Arthrex, Inc. (2002) Summary page 1.
- K010673: Arthrex Fiberwire, Model Spu-02NB-3800, Arthrex, Inc. (2001) Summary page 1.
- K012923: Arthrex Fiberwire, Usp Size 5, Model AR-7201, Arthrex, Inc. (2001) Summary page 1.
- K003590: Grams Polyester Nonabsorbable Suture, Gramsmed, LLC (2001) 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.

## Most influential descendants
- K122374: Arthrex Suture (Uhmwpe) (2012), 13 descendants of its own
- K170957: ReConnex Pre-Sutured Tendon (2018), 3 descendants of its own
- K171296: SutureTape (2017), 3 descendants of its own
- K112899: Arthrex Bio-Suture (2012), 3 descendants of its own
- K071622: Arthrex Fiberwire (2007), 3 descendants of its own

## Indications for use
The Arthrex Fiberwire TM and FiberTape TM Families 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/K041553
Methodology: https://510kreport.com/methodology