510(k) Report

510(k) · Cleared

Cleared

Sepramesh IP Bioresorbable Barrier - Permanent Mesh

K040868510(k) TraditionalCleared Jun 4, 200463-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

Genzyme Corp. · FTM Mesh, Surgical

Cleared on Jun 4, 2004 as substantially equivalent to K994328 (Genzyme Corp., 2000) and 3 other predicates after a 63-day review. Its family tree reaches back 2 generations to 1997. 34 later devices descend from it.

Decided
Jun 4, 2004
Review
63 days
Class
Class II
Product code
FTM
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K971745 (1997). 5 ancestors in all, the oldest K810428 (1981). 34 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1983: 1 other ancestor1981: 1 other ancestor2011: 3 descendants cleared2005: 1 descendant cleared2006: 1 descendant cleared2010: 1 descendant cleared2007: 1 descendant cleared2008: 2 descendants cleared2014: 4 descendants cleared2012: 2 descendants cleared2013: 2 descendants cleared2015: 3 descendants cleared2019: 3 descendants cleared2025: 1 descendant cleared2018: 4 descendants cleared2016: 1 descendant cleared2017: 2 descendants cleared2022: 1 descendant cleared2021: 1 descendant cleared2020: 1 descendant clearedK971745 · Bard Composite Prosthesis · Davol Inc., Sub. C. R. Bard, Inc. · 1997K994328 · Sepramesh Biosurgical Composite, Model SMBC-XXX · Genzyme Corp. · 200019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 5 descendants2 generations forward: 11 descendants3 generations forward: 7 descendants4 generations forward: 8 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant7 generations forward: 1 descendant K994328 · Sepramesh Biosurgical Composite, Model SMBC-XXX · Genzyme Corp. · 2000K971745 · Bard Composite Prosthesis · Davol Inc., Sub. C. R. Bard, Inc. · 19970+5
  1. Root · 2 generations backK971745 Bard Composite ProsthesisDavol Inc., Sub. C. R. Bard, Inc. · 1997
  2. 1 generation backK994328 Sepramesh Biosurgical Composite, Model SMBC-XXXGenzyme Corp. · 2000
  3. This deviceK040868 Sepramesh IP Bioresorbable Barrier - Permanent MeshGenzyme Corp. · 2004
  4. Descendant · cites it directly · 17 of its ownK053066 Sepramesh IP Bioresorbable Coating/Permanent MeshGenzyme Corporation · 2005
  5. Descendant · 2 generations on · 16 of its ownK063739 Sepramesh, Model 5959-1214Genzyme Corporation · 2007
  6. Descendant · cites it directly · 15 of its ownK062915 Veritas Collagen MatrixSynovis Surgical Innovations · 2006 · Recalled
  7. Descendant · cites it directly · 10 of its ownK101851 Ventralight ST MeshDavol Inc., Sub. C. R. Bard, Inc. · 2010 · Recalled
  8. Descendant · 2 generations on · 8 of its ownK073391 Surgisis Biodesign Tissue GraftCook Biotech, Inc. · 2008

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12007: 12008: 22010: 12011: 32012: 22013: 22014: 42015: 32016: 12017: 22018: 42019: 32020: 12021: 12022: 12025: 1
2005high 4 (2014) · low 0 (2009)2026

Most influential descendants

Showing 5 of 34 · See all
  • K053066Sepramesh IP Bioresorbable Coating/Permanent MeshGenzyme Corporation · 2005 · cites it directly17descendants
  • K063739Sepramesh, Model 5959-1214Genzyme Corporation · 2007 · 2 generations on16descendants
  • K062915Veritas Collagen MatrixSynovis Surgical Innovations · 2006 · cites it directly15descendants
  • K101851Ventralight ST MeshDavol Inc., Sub. C. R. Bard, Inc. · 2010 · cites it directly10descendants
  • K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc. · 2008 · 2 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K971745Bard Composite ProsthesisDavol Inc., Sub. C. R. Bard, Inc.1997—
−1K994328Sepramesh Biosurgical Composite, Model SMBC-XXXGenzyme Corp.2000—
0 (this device)K040868Sepramesh IP Bioresorbable Barrier - Permanent MeshGenzyme Corp.2004—
+1K053066Sepramesh IP Bioresorbable Coating/Permanent MeshGenzyme Corporation2005—
+2K063739Sepramesh, Model 5959-1214Genzyme Corporation2007—
+1K062915Veritas Collagen MatrixSynovis Surgical Innovations20061
+1K101851Ventralight ST MeshDavol Inc., Sub. C. R. Bard, Inc.20102
+2K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198310
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200710
200820
201010
201130
201220
201320
201440
201530
201610
201720
201840
201930
202010
202110
202210
202510
FIG. 1 — Lineage of K040868, 1997–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 FTM? 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 FTM device

  1. #1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K994328Sepramesh Biosurgical Composite, Model SMBC-XXX
Summary page 2
…facturer 510(k) Number (Town, State) Sepramesh TM Genzyme Corporation, K994328 Cambridge, MA Bard®D Mesh Davol Inc., Cranston, RI…
Genzyme Corp.2000—
*K002684Composix E/X Mesh
Summary page 2
…Bard®D Mesh Davol Inc., Cranston, RI Pro-amendment Bard® Composix®)EfX Davol Inc., Cranston, RI KK002684 Mesh VicryFrM Knitted Mesh Ethicon Inc., Somerville, NJ K810428 Dexon® PGA Mesh…
C.R. Bard, Inc.2000—
*K810428Vicryl
Summary page 2
…Bard® Composix®)EfX Davol Inc., Cranston, RI KK002684 Mesh VicryFrM Knitted Mesh Ethicon Inc., Somerville, NJ K810428 Dexon® PGA Mesh Davis & Geck Inc., Norwalk, CT 1K830889 10.7 Device Description: Sepram…
ETHICON, Inc.1981—
*K830889Dexon 'S' Polyglycolic Acid Mesh
Summary page 2
…Mesh VicryFrM Knitted Mesh Ethicon Inc., Somerville, NJ K810428 Dexon® PGA Mesh Davis & Geck Inc., Norwalk, CT 1K830889 10.7 Device Description: Sepramesh TM IP Bioresorbable Coating - Permanent Mesh (Sepramesh TM IP) is a dual- c…
Davis & Geck, Inc.1983—
*—Bard D Mesh
Named without a submission number
—

Also cleared against K994328: 1 other device →

What descends from it? (34)

See all 34

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

NumberDeviceApplicantDecidedDescendants
K053066Sepramesh IP Bioresorbable Coating/Permanent MeshGenzyme Corporation200517
K062915Veritas Collagen MatrixSynovis Surgical Innovations200615
K101851Ventralight ST MeshDavol Inc., Sub. C. R. Bard, Inc.201010
K101920Ventrio ST Hernia PatchC.R. Bard, Inc.20113
K101928Ventralex ST Hernia PatchC.R. Bard, Inc.20111

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 7 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K053066 (Genzyme Corporation, 2005) has gone furthest, with 17 descendants of its own.
  • 1 other device also cites its predicate K994328.

How does its category compare?

All FTM devices

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

FDA decisions per year · FTM

1in 2025

2007: 92008: 92009: 72010: 22011: 62012: 42013: 42014: 82015: 42016: 72017: 92018: 22019: 62020: 42021: 42023: 22024: 32025: 12026 (partial year): 1
2007high 9 (2007) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTM

29in 2024

2007: 104 days median2008: 86 days median2009: 86 days median2011: 100 days median2012: 66 days median2013: 123 days median2014: 153 days median2015: 316 days median2016: 88 days median2017: 147 days median2019: 107 days median2020: 59 days median2021: 61 days median2024: 29 days median
2007high 316 (2015) · low 29 (2024)2026

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

Recalls per year · FTM

1in 2023

2007: 72008: 12010: 12011: 82018: 212019: 42020: 12021: 12023: 1
2007high 21 (2018) · low 0 (2009)2026

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

Adverse event reports per year · FTM

232in 2025

2007: 602008: 1412009: 4762010: 1972011: 2882012: 4672013: 3,3512014: 1,0932015: 9772016: 5092017: 5292018: 3572019: 4182020: 4572021: 3692022: 3752023: 4852024: 3832025: 232
2007high 3,351 (2013) · low 60 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20079104760
20089861141
20097860476
20102—1197
201161008288
20124660467
2013412303,351
2014815301,093
201543160977
20167880509
201791470529
20182—21357
201961074418
20204591457
20214611369
20220—0375
20232—1485
20243290383
20251—0232
20261—0—

What is it indicated for?

Sepramesh Tm IP Bioresorbable Coating - Permanent Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

Indications for use as stated in the FDA summary.

Also cleared against K994328

1 other device cites the same predicate.

  • K053066Sepramesh IP Bioresorbable Coating/Permanent MeshGenzyme Corporation · 2005

More from Genzyme Corp.

38 FDA decisions under this applicant name. See the company

Recent decisions in FTM

The FTM category page

  • K262406EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific · 2026
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  • K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc. · 2024
  • K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc. · 2024
  • K241126OviTex PRSTELA Bio, Inc. · 2024

https://510kreport.com/device/K040868 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040868: Sepramesh IP Bioresorbable Barrier - Permanent Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040868

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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