# K033718: Maxbraid Polyester Plus and Polyethylene Plus Suture

- Pathway: 510(k) (Traditional)
- Applicant: Arthrotek, Inc.
- Decided: Feb 12, 2004 after 78 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 K001172 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.
- K001172: Polyester Nonabsorbable Surgical Sutures Urp, Cp Medical (2000) Summary page 1.

## Indications for use
MaxBraid TM Polyethylene Plus and Polyester Plus suture is indicated for general soft tissue approximation and/or ligation

Source page: https://510kreport.com/device/K033718
Methodology: https://510kreport.com/methodology