510(k) · Cleared

Cleared

Nuvasive Mesh

K020853510(k) TraditionalCleared Jun 13, 200290-day reviewClass II21 CFR 878.3300

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

Nuvasive, Inc. · EZX Mesh, Surgical, Metal

Cleared on Jun 13, 2002 as substantially equivalent to K983766 (Synthes (Usa), 1998) and 3 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1990.

Decided: Jun 13, 2002
Review: 90 days
Class: Class II
Product code: EZX
Recalls: None
Predicates: 4

Its longest line of descent runs back 2 generations to K900138 (1990). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK900138 Motech Titanium Surgical MeshBiedermann Motech GmbH · 1990
1 generation backK983766 Synthes SynmeshSynthes (Usa) · 1998 · Recalled
This deviceK020853 Nuvasive MeshNuvasive, Inc. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K900138	Motech Titanium Surgical Mesh	Biedermann Motech GmbH	1990	—
−1	K983766	Synthes Synmesh	Synthes (Usa)	1998	14
0 (this device)	K020853	Nuvasive Mesh	Nuvasive, Inc.	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0

FIG. 1 — Lineage of K020853, 1990–2002Source: 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 EZX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (4)

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
*	K983766	Synthes Synmesh Summary page 1 …Surgical Mesh C. Predicate Devices The subject device is substantially equivalent to the Spnthes@SynmeshTMSystem ( 5 1O([k] submission No. K983766), Depuy-MotechTMTitanium Surgical Mesh ( 5 1O([k] submission No. K900138), and Sofamor Danek's TimeshTM/PyrameshTMSyste…	Synthes (Usa)	1998	14
*	K900138	Motech Titanium Surgical Mesh Summary page 1 …antially equivalent to the Spnthes@SynmeshTMSystem ( 5 1O([k] submission No. K983766), Depuy-MotechTMTitanium Surgical Mesh ( 5 1O([k] submission No. K900138), and Sofamor Danek's TimeshTM/PyrameshTMSystem ( 5 lO([k] submission No. K974017K973 145). D. Device Descriptio…	Biedermann Motech GmbH	1990	—
*	K974017	Timesh System Summary page 1 …66), Depuy-MotechTMTitanium Surgical Mesh ( 5 1O([k] submission No. K900138), and Sofamor Danek's TimeshTM/PyrameshTMSystem ( 5 lO([k] submission No. K974017K973 145). D. Device Description The NuVasive' Mesh is a rhombic pattern surgical mesh device intended for the r…	Sofamor Danek USA,Inc.	1998	1
*	K973145	Timesh Titanium Mini-Softplate and Micro-Soft Plate/Screw System Summary page 1 …puy-MotechTMTitanium Surgical Mesh ( 5 1O([k] submission No. K900138), and Sofamor Danek's TimeshTM/PyrameshTMSystem ( 5 lO([k] submission No. K974017K973 145). D. Device Description The NuVasive' Mesh is a rhombic pattern surgical mesh device intended for the reinforce…	Sofamor Danek USA,Inc.	1997	—

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?

The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
2 of the 4 ancestors have a recall of any class.

How does its category compare?

All EZX devices

EZX Mesh, Surgical, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EZX

1in 2009

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EZX

Too few EZX 510(k)s in any year since 2007 to give a median.

Recalls per year · EZX

1in 2015

2007high 1 (2015) · low 0 (2007)2026

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

Adverse event reports per year · EZX

1in 2025

2007high 35 (2021) · low 1 (2025)2025

MAUDE reports naming product code EZX, 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	0	—	0	4
2008	0	—	0	8
2009	1	—	0	5
2010	0	—	0	8
2011	0	—	0	6
2012	0	—	0	11
2013	0	—	0	8
2014	0	—	0	7
2015	0	—	1	9
2016	0	—	0	4
2017	0	—	0	7
2018	0	—	0	11
2019	0	—	0	29
2020	0	—	0	25
2021	0	—	0	35
2022	0	—	0	4
2023	0	—	0	5
2024	0	—	0	5
2025	0	—	0	1
2026	0	—	0	—

What is it indicated for?

The Nu Vasive® Mesh is indicated for use in the reinforcement of weak bony tissue in orthopedic procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K020853 · printed Nov 5, 2026

Cite this page

510(k) Report. “K020853: Nuvasive Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020853

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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