510(k) · Cleared

Cleared

Modification to Brennen Biosynthetic Surgical Mesh Matrix

K993459510(k) SpecialCleared Nov 5, 199923-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

Advanced Uroscience, Inc. · PAG Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Cleared on Nov 5, 1999 as substantially equivalent to K982403 (Brennen Medical, Inc., 1998) after a 23-day review. Its family tree reaches back 1 generation to 1998. 40 later devices descend from it.

Decided: Nov 5, 1999
Review: 23 days
Class: Class II
Product code: PAG
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K982403 (1998). 40 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK982403 Brennen Biosynthetic Surgical Mesh MatrixBrennen Medical, Inc. · 1998
This deviceK993459 Modification to Brennen Biosynthetic Surgical Mesh MatrixAdvanced Uroscience, Inc. · 1999
Descendant · cites it directly · 38 of its ownK021160 Dermmatrix Surgical MeshCarbon Medical Technologies, Inc. · 2002
Descendant · 2 generations on · 30 of its ownK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
Descendant · 3 generations on · 17 of its ownK051485 Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005
Descendant · 3 generations on · 12 of its ownK073219 WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT…American Medical Systems, Inc. · 2008
Descendant · 4 generations on · 11 of its ownK120019 Collagen RibbonWrightmedicaltechnologyinc · 2012

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2002high 7 (2008) · low 0 (2004)2026

Most influential descendants

Showing 5 of 40 · See all

K021160Dermmatrix Surgical MeshCarbon Medical Technologies, Inc. · 2002 · cites it directly38descendants
K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · 2 generations on30descendants
K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005 · 3 generations on17descendants
K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc. · 2008 · 3 generations on12descendants
K120019Collagen RibbonWrightmedicaltechnologyinc · 2012 · 4 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K982403	Brennen Biosynthetic Surgical Mesh Matrix	Brennen Medical, Inc.	1998	—
0 (this device)	K993459	Modification to Brennen Biosynthetic Surgical Mesh Matrix	Advanced Uroscience, Inc.	1999	—
+1	K021160	Dermmatrix Surgical Mesh	Carbon Medical Technologies, Inc.	2002	—
+2	K050445	Ams Collagen Dermal Matrix	American Medical Systems, Inc.	2005	1
+3	K051485	Ams Pelvic Floor Repair System	American Medical Systems, Inc.	2005	—
+3	K073219	WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal…	American Medical Systems, Inc.	2008	—
+4	K120019	Collagen Ribbon	Wrightmedicaltechnologyinc	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2005	2	0
2006	1	0
2007	1	0
2008	7	0
2009	2	0
2011	3	0
2012	4	0
2013	1	0
2014	2	0
2015	1	0
2016	3	0
2022	2	0
2023	2	0
2024	1	0
2025	3	0
2026	3	0

FIG. 1 — Lineage of K993459, 1998–2026Source: 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 PAG? 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

Get a 510(k) Report

What was it cleared against? (1)

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
*	K982403	Brennen Biosynthetic Surgical Mesh Matrix Summary page 1 …de Name: [trade name] Classification Name: Surgical Mesh, 21 CFR 878.3300 Common/Usual Name: Surgical Mesh Predicate Device Brennen Biosynthetic Surgical Mesh Matrix (K982403) Indication for Use For use in the treatment of hernias where the connective tissue has ruptured or as a sling material to supp…	Brennen Medical, Inc.	1998	—

Also cleared against K982403: 1 other device →

What descends from it? (40)

See all 40

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K021160	Dermmatrix Surgical Mesh	Carbon Medical Technologies, Inc.	2002	38
K030460	Modification to Brennen Biosynthetic Surgical Mesh Matrix	Brennen Medical, Inc.	2003	7
K081272	Porcine Surgical Mesh; Dermal Matrix	Brennen Medical, LLC	2008	6

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?

Its one ancestor has no recall.
Of its descendants, K021160 (Carbon Medical Technologies, Inc., 2002) has gone furthest, with 38 descendants of its own.
1 other device also cites its predicate K982403.

How does its category compare?

All PAG devices

PAG Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · PAG

1in 2009

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PAG

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

Recalls per year · PAG

No recall names PAG since 2007.

Adverse event reports per year · PAG

1in 2023

2007high 299 (2016) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	1
2009	1	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	84
2014	0	—	256
2015	0	—	73
2016	0	—	299
2017	0	—	11
2018	0	—	4
2019	0	—	17
2020	0	—	4
2021	0	—	5
2022	0	—	1
2023	0	—	1
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

For use in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female urinary incontinence resulting from urethral hypermobility or sphincter deficiency.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K993459 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993459: Modification to Brennen Biosynthetic Surgical Mesh Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993459

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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