510(k) Report

510(k) · Cleared

Cleared

Sepramesh IP Bioresorbable Coating/Permanent Mesh

K053066510(k) TraditionalCleared Dec 19, 200548-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 Corporation · FTL Mesh, Surgical, Polymeric

Cleared on Dec 19, 2005 as substantially equivalent to K040868 (Genzyme Corp., 2004) and 4 other predicates after a 48-day review. Its family tree reaches back 3 generations to 1997. 17 later devices descend from it.

Decided
Dec 19, 2005
Review
48 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K971745 (1997). 6 ancestors in all, the oldest K810428 (1981). 17 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1983: 1 other ancestor1981: 1 other ancestor2007: 1 descendant cleared2011: 3 descendants cleared2010: 1 descendant cleared2015: 2 descendants cleared2014: 1 descendant cleared2019: 1 descendant cleared2025: 1 descendant cleared2012: 1 descendant cleared2018: 3 descendants cleared2013: 1 descendant cleared2017: 1 descendant cleared2022: 1 descendant clearedK971745 · Bard Composite Prosthesis · Davol Inc., Sub. C. R. Bard, Inc. · 1997K994328 · Sepramesh Biosurgical Composite, Model SMBC-XXX · Genzyme Corp. · 2000K040868 · Sepramesh IP Bioresorbable Barrier - Permanent Mesh · Genzyme Corp. · 200419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 4 descendants4 generations forward: 4 descendants K040868 · Sepramesh IP Bioresorbable Barrier - Permanent Mesh · Genzyme Corp. · 2004K994328 · Sepramesh Biosurgical Composite, Model SMBC-XXX · Genzyme Corp. · 2000K971745 · Bard Composite Prosthesis · Davol Inc., Sub. C. R. Bard, Inc. · 19970
  1. Root · 3 generations backK971745 Bard Composite ProsthesisDavol Inc., Sub. C. R. Bard, Inc. · 1997
  2. 2 generations backK994328 Sepramesh Biosurgical Composite, Model SMBC-XXXGenzyme Corp. · 2000
  3. 1 generation backK040868 Sepramesh IP Bioresorbable Barrier - Permanent MeshGenzyme Corp. · 2004
  4. This deviceK053066 Sepramesh IP Bioresorbable Coating/Permanent MeshGenzyme Corporation · 2005
  5. Descendant · cites it directly · 16 of its ownK063739 Sepramesh, Model 5959-1214Genzyme Corporation · 2007
  6. Descendant · cites it directly · 10 of its ownK101851 Ventralight ST MeshDavol Inc., Sub. C. R. Bard, Inc. · 2010 · Recalled
  7. Descendant · 2 generations on · 5 of its ownK110820 Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011
  8. Descendant · 2 generations on · 4 of its ownK143380 Phasix ST MeshC.R. Bard, Inc. · 2015
  9. Descendant · 3 generations on · 4 of its ownK122436 Composix L/P Mesh with Echo PS Positioning System Ventralight ST…C.R. Bard, Inc. · 2012 · Recalled

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2007: 12010: 12011: 32012: 12013: 12014: 12015: 22017: 12018: 32019: 12022: 12025: 1
2007high 3 (2011) · low 0 (2008)2026

Most influential descendants

Showing 5 of 17 · See all
  • K063739Sepramesh, Model 5959-1214Genzyme Corporation · 2007 · cites it directly16descendants
  • K101851Ventralight ST MeshDavol Inc., Sub. C. R. Bard, Inc. · 2010 · cites it directly10descendants
  • K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011 · 2 generations on5descendants
  • K143380Phasix ST MeshC.R. Bard, Inc. · 2015 · 2 generations on4descendants
  • K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS…C.R. Bard, Inc. · 2012 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K971745Bard Composite ProsthesisDavol Inc., Sub. C. R. Bard, Inc.1997—
−2K994328Sepramesh Biosurgical Composite, Model SMBC-XXXGenzyme Corp.2000—
−1K040868Sepramesh IP Bioresorbable Barrier - Permanent MeshGenzyme Corp.2004—
0 (this device)K053066Sepramesh IP Bioresorbable Coating/Permanent MeshGenzyme Corporation2005—
+1K063739Sepramesh, Model 5959-1214Genzyme Corporation2007—
+1K101851Ventralight ST MeshDavol Inc., Sub. C. R. Bard, Inc.20102
+2K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc.2011—
+2K143380Phasix ST MeshC.R. Bard, Inc.2015—
+3K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with…C.R. Bard, Inc.201215

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198310
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201010
201130
201210
201310
201410
201520
201710
201830
201910
202210
202510
FIG. 1 — Lineage of K053066, 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 FTL? 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 FTL device

  1. #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 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? (6)

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
*K040868Sepramesh IP Bioresorbable Barrier - Permanent Mesh
Summary page 1
…Name of Manufacturer 510(k) Number (Town, State) Sepramnesh'T M IP Genzyme Corporation, K040868 Cambridge, MA SepramneShTMI Genzyme Corporation, K994328 Pr…
Genzyme Corp.2004—
*K994328Sepramesh Biosurgical Composite, Model SMBC-XXX
Summary page 1
…Genzyme Corporation, K040868 Cambridge, MA SepramneShTMI Genzyme Corporation, K994328 Proprietary and Confidential DOCUMENT INFO: SEI'RAMESFIIPSICKFINAI~woAPPlENDICES I.DOC…
Genzyme Corp.2000—
*K002684Composix E/X Mesh
Summary page 2
…ramesh Tm IP Bioresorbable Coating/Permanent Mesh Cambridge, MA Bard® Composix® E/X Mesh Davol Inc., Cranston, RI K002684 Bard® Mesh Davol Inc., Cranston, RI Pre-Amendment Vicry TM Knitted Mesh Ethicon Inc…
C.R. Bard, Inc.2000—
*K810428Vicryl
Summary page 2
…, RI K002684 Bard® Mesh Davol Inc., Cranston, RI Pre-Amendment Vicry TM Knitted Mesh Ethicon Inc., Somerville, NJ K810428 Dexon® PGA Mesh Davis & Geck Inc., Norwalk, K830889 CT 1.7…
ETHICON, Inc.1981—
*K830889Dexon 'S' Polyglycolic Acid Mesh
Summary page 2
…, RI Pre-Amendment Vicry TM Knitted Mesh Ethicon Inc., Somerville, NJ K810428 Dexon® PGA Mesh Davis & Geck Inc., Norwalk, K830889 CT 1.7 Device Description:…
Davis & Geck, Inc.1983—
*—Bard Mesh
Named without a submission number
—

Also cleared against K040868: 4 other devices →

What descends from it? (17)

See all 17

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

NumberDeviceApplicantDecidedDescendants
K063739Sepramesh, Model 5959-1214Genzyme Corporation200716
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 8 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K063739 (Genzyme Corporation, 2007) has gone furthest, with 16 descendants of its own.
  • 4 other devices also cite its predicate K040868.

How does its category compare?

All FTL devices

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

FDA decisions per year · FTL

6in 2025

2007: 202008: 232009: 152010: 182011: 152012: 122013: 82014: 112015: 122016: 32017: 62018: 122019: 42020: 52021: 22022: 62023: 42024: 22025: 62026 (partial year): 2
2007high 23 (2008) · low 2 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTL

30in 2025

2007: 92 days median2008: 114 days median2009: 97 days median2010: 132 days median2011: 90 days median2012: 213 days median2013: 90 days median2014: 70 days median2015: 121 days median2016: 186 days median2017: 132 days median2018: 105 days median2019: 99 days median2020: 138 days median2022: 195 days median2023: 29 days median2025: 30 days median
2007high 213 (2012) · low 29 (2023)2026

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

Recalls per year · FTL

1in 2020

2007: 22008: 12009: 12010: 122011: 82012: 22013: 12014: 32017: 12018: 12020: 1
2007high 12 (2010) · low 0 (2015)2026

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

Adverse event reports per year · FTL

3,487in 2025

2007: 1,7372008: 1,5692009: 1,9062010: 2,1752011: 3,6082012: 14,7002013: 26,5192014: 2,6832015: 2,5262016: 2,4172017: 3,9472018: 11,8932019: 21,7242020: 18,8192021: 16,2842022: 11,4392023: 8,0252024: 8,5652025: 3,487
2007high 26,519 (2013) · low 1,569 (2008)2025

MAUDE reports naming product code FTL, 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
2007209221,737
20082311411,569
2009159711,906
201018132122,175
2011159083,608
201212213214,700
2013890126,519
2014117032,683
20151212102,526
2016318602,417
2017613213,947
201812105111,893
2019499021,724
20205138118,819
20212—016,284
20226195011,439
202342908,025
20242—08,565
202563003,487
20262—0—

What is it indicated for?

Sepramesh TM IP Bioresorbable Barrier - 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 K040868

4 other devices cite the same predicate.

  • K101928Ventralex ST Hernia PatchC.R. Bard, Inc. · 20111 recall
  • K101920Ventrio ST Hernia PatchC.R. Bard, Inc. · 2011
  • K101851Ventralight ST MeshDavol Inc., Sub. C. R. Bard, Inc. · 20102 recalls
  • K062915Veritas Collagen MatrixSynovis Surgical Innovations · 20061 recall

More from Genzyme Corporation

6 FDA decisions under this applicant name. See the company

  • K102242Osom C. Difficile Toxin a/B TestGenzyme Corporation · 20101 recall
  • K092633Osom Influenza a&B Test , Model PN190Genzyme Corporation · 2009
  • K080662Genzyme Cystatin C Reagent Anf Genzyme Cystatin C CalibratorGenzyme Corporation · 2008
  • K063739Sepramesh, Model 5959-1214Genzyme Corporation · 2007
  • K043035Sepragel Ent Bioresorbable Packing/StentGenzyme Corporation · 2005

Recent decisions in FTL

The FTL category page

  • K260474Liora Monofilament ScaffoldTELA Bio, Inc. · 2026
  • K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production · 2026
  • K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production · 2025
  • K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc. · 2025
  • K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc. · 2025

https://510kreport.com/device/K053066 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053066: Sepramesh IP Bioresorbable Coating/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/K053066

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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