510(k) · Cleared

Cleared

Maxbraid Polyester Plus and Polyethylene Plus Suture

K033718510(k) TraditionalCleared Feb 12, 200478-day reviewClass II21 CFR 878.5000

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Arthrotek, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Feb 12, 2004 as substantially equivalent to K010673 (Arthrex, Inc., 2001) and 1 other predicate after a 78-day review. Its family tree reaches back 1 generation to 2000.

Decided: Feb 12, 2004
Review: 78 days
Class: Class II
Product code: GAT
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K001172 (2000). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK001172 Polyester Nonabsorbable Surgical Sutures UrpCp Medical · 2000 · Recalled
This deviceK033718 Maxbraid Polyester Plus and Polyethylene Plus SutureArthrotek, Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001172	Polyester Nonabsorbable Surgical Sutures Urp	Cp Medical	2000	1
0 (this device)	K033718	Maxbraid Polyester Plus and Polyethylene Plus Suture	Arthrotek, Inc.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

FIG. 1 — Lineage of K033718, 2000–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GAT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GAT device

#1 K230311 HyperSuturescore 20.2 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K010673	Arthrex Fiberwire, Model Spu-02NB-3800 Summary page 1 …ble, synthetic, polyethylene (21 CFR 878.500) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Arthrex FiberWIRE T M - K010673 (Arthrex, Inc.) and Polyester Nonabsorbable Surgical Suture - K001 172 (CP Medical) Device Description: Two configurations of Max…	Arthrex, Inc.	2001	—
*	K001172	Polyester Nonabsorbable Surgical Sutures Urp Summary page 1 …s To Which Substantial Equivalence Is Claimed: Arthrex FiberWIRE T M - K010673 (Arthrex, Inc.) and Polyester Nonabsorbable Surgical Suture - K001 172 (CP Medical) Device Description: Two configurations of MaxBraid TM suture are included in this submission. The first consists of…	Cp Medical	2000	1

Also cleared against K010673: 7 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
7 other devices also cite its predicate K010673.

How does its category compare?

All GAT devices

GAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAT

5in 2025

2007high 11 (2010) · low 1 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAT

30in 2025

2007high 220 (2023) · low 27 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GAT

1in 2011

2007high 3 (2010) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GAT

2,956in 2025

2007high 2,956 (2025) · low 15 (2007)2025

MAUDE reports naming product code GAT, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	40	1	15
2008	4	93	0	15
2009	9	57	0	55
2010	11	27	3	79
2011	1	—	1	97
2012	6	61	0	253
2013	4	123	0	210
2014	4	45	0	165
2015	7	125	0	626
2016	10	139	0	688
2017	6	57	0	1,104
2018	6	95	0	1,453
2019	4	79	0	1,251
2020	5	201	0	1,220
2021	4	92	0	1,643
2022	5	109	0	1,419
2023	8	220	0	2,038
2024	3	140	0	2,597
2025	5	30	0	2,956
2026	5	83	0	—

What is it indicated for?

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033718 · printed Nov 4, 2026

Cite this page

510(k) Report. “K033718: Maxbraid Polyester Plus and Polyethylene Plus Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033718

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026