510(k) Report

510(k) · Cleared

Cleared

Dynamesh-PP Standard, Model PP02NNNN, Dynamesh-PP Light, Model PP01NNNN

K073579510(k) TraditionalCleared Aug 18, 2008242-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

Feg Textiltechnik Forschungs-Und Entwicklungsgesel · FTL Mesh, Surgical, Polymeric

Cleared on Aug 18, 2008 as substantially equivalent to K991400 (Sofradim Production, 1999) and 7 other predicates after a 242-day review. Its family tree reaches back 3 generations to 1996. 3 later devices descend from it.

Decided
Aug 18, 2008
Review
242 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
8

Its longest line of descent runs back 3 generations to K962530 (1996). 11 ancestors in all, the oldest K792281 (1979). 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2003: 1 other ancestor2000: 2 other ancestors1999: 1 other ancestor1993: 1 other ancestor1992: 1 other ancestor1979: 1 other ancestor2013: 1 descendant cleared2016: 1 descendant cleared2018: 1 descendant clearedK962530 · Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh · ETHICON, Inc. · 1996×2: 2 generations cleared close together, K053158 (2006), K061704 (2006) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors3 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K061704 · Optilene Mesh · Aesculap, Inc. · 2006K053158 · Optilene Mesh LP · Aesculap, Inc. · 2006K962530 · Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh · ETHICON, Inc. · 19960
  1. Root · 3 generations backK962530 Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical MeshETHICON, Inc. · 1996
  2. 2 generations backK053158 Optilene Mesh LPAesculap, Inc. · 2006
  3. 1 generation backK061704 Optilene MeshAesculap, Inc. · 2006
  4. This deviceK073579 Dynamesh-PP Standard, Model PP02NNNN, Dynamesh-PP Light, Model…Feg Textiltechnik Forschungs-Und Entwicklungsgesel · 2008
  5. Descendant · cites it directly · 2 of its ownK131530 Dynamesh -CicatFeg Textiltechnik Forschungs-Und Entwicklungsgesel · 2013
  6. Descendant · 2 generations on · 1 of its ownK161550 DynaMesh-VENTRALFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft · 2016
  7. Descendant · 3 generations on · 0 of its ownK182087 DynaMesh-POSTERIORFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft · 2018

Most influential descendants

Showing 3 of 3 · See all
  • K131530Dynamesh -CicatFeg Textiltechnik Forschungs-Und Entwicklungsgesel · 2013 · cites it directly2descendants
  • K161550DynaMesh-VENTRALFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft · 2016 · 2 generations on1descendant
  • K182087DynaMesh-POSTERIORFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft · 2018 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K962530Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical MeshETHICON, Inc.1996—
−2K053158Optilene Mesh LPAesculap, Inc.2006—
−1K061704Optilene MeshAesculap, Inc.2006—
0 (this device)K073579Dynamesh-PP Standard, Model PP02NNNN, Dynamesh-PP Light, Model PP01NNNNFeg Textiltechnik Forschungs-Und Entwicklungsgesel2008—
+1K131530Dynamesh -CicatFeg Textiltechnik Forschungs-Und Entwicklungsgesel2013—
+2K161550DynaMesh-VENTRALFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft2016—
+3K182087DynaMesh-POSTERIORFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
199210
199310
199910
200020
200310
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201610
201810
FIG. 1 — Lineage of K073579, 1996–2018Source: 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? (8)

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
*K991400Parietene Polypropylene Mesh
Summary page 2
…l Equivalence: The FEG Textiltechnik DynaMesh-PP is substantially equivalent in design, use and materials to the: Sofradim Production Pariente Polypropylene Mesh - K991400 GFE Medizintechnik GmbH TiMESH, TiMESH-TC - K031225 Aesculap Inc Optilene Mesh - K061704 Davol/Bard (Usher'…
Sofradim Production1999—
*K031225Timesh Also Known as Timesh-TC, Models 6000001 & 6000004
Summary page 2
…ntially equivalent in design, use and materials to the: Sofradim Production Pariente Polypropylene Mesh - K991400 GFE Medizintechnik GmbH TiMESH, TiMESH-TC - K031225 Aesculap Inc Optilene Mesh - K061704 Davol/Bard (Usher's) Marlex (various) - K792281, K922916 Atrium Medica…
Gfe Medizintechnik GmbH2003—
*K061704Optilene Mesh
Summary page 2
…ials to the: Sofradim Production Pariente Polypropylene Mesh - K991400 GFE Medizintechnik GmbH TiMESH, TiMESH-TC - K031225 Aesculap Inc Optilene Mesh - K061704 Davol/Bard (Usher's) Marlex (various) - K792281, K922916 Atrium Medical Corp Meshes (various) - K930669, K002093,…
Aesculap, Inc.2006—
*K792281Usher's Marlex Tubular Mesh
Summary page 2
…ene Mesh - K991400 GFE Medizintechnik GmbH TiMESH, TiMESH-TC - K031225 Aesculap Inc Optilene Mesh - K061704 Davol/Bard (Usher's) Marlex (various) - K792281, K922916 Atrium Medical Corp Meshes (various) - K930669, K002093, K070192 The FEG Textiltechnik Forschungs- und Entwicklun…
Davol, Inc.19791
*K922916Bard Marlex Mesh Dart
Summary page 2
…- K991400 GFE Medizintechnik GmbH TiMESH, TiMESH-TC - K031225 Aesculap Inc Optilene Mesh - K061704 Davol/Bard (Usher's) Marlex (various) - K792281, K922916 Atrium Medical Corp Meshes (various) - K930669, K002093, K070192 The FEG Textiltechnik Forschungs- und Entwicklungsgesells…
C.R. Bard, Inc.1992—
*K930669Atrium Polypropylene Mesh
Summary page 2
…H-TC - K031225 Aesculap Inc Optilene Mesh - K061704 Davol/Bard (Usher's) Marlex (various) - K792281, K922916 Atrium Medical Corp Meshes (various) - K930669, K002093, K070192 The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh-PP is made of the same basic mater…
Atrium Medical Corp.1993—
*K002093Atrium Lite Mesh
Summary page 2
…31225 Aesculap Inc Optilene Mesh - K061704 Davol/Bard (Usher's) Marlex (various) - K792281, K922916 Atrium Medical Corp Meshes (various) - K930669, K002093, K070192 The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh-PP is made of the same basic material as th…
Atrium Medical Corp.2000—
*K070192Atrium Prolite Ultra S Mesh
Summary page 2
…Aesculap Inc Optilene Mesh - K061704 Davol/Bard (Usher's) Marlex (various) - K792281, K922916 Atrium Medical Corp Meshes (various) - K930669, K002093, K070192 The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh-PP is made of the same basic material as the Sofradi…
Atrium Medical Corp.2007—

Also cleared against K991400: 7 other devices →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K131530Dynamesh -CicatFeg Textiltechnik Forschungs-Und Entwicklungsgesel20132

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 2.1 years on median.
  • 1 of the 11 ancestors has a recall of any class.
  • Of its descendants, K131530 (Feg Textiltechnik Forschungs-Und Entwicklungsgesel, 2013) has gone furthest, with 2 descendants of its own.
  • 7 other devices also cite its predicate K991400.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

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?

DynaMesh-PP is a polypropylene mesh intended to support tissue and stabilize

fascial structures of the abdominal wall.

DynaMesh-PP is indicated for repairing hernias, parietal reinforcement of

tissues and abdominal wall repair.

Indications for use as stated in the FDA summary.

Also cleared against K991400

7 other devices cite the same predicate.

  • K140941Progrip Self-Gripping Polypropylene Mesh, Parietene Flat Sheet MeshSofradim Production · 2014
  • K101197Parie Tene Progrip MeshSofradim Production · 2010
  • K073164Ivs Tunneller DevicesCovidien UK Manufacturing, Ltd. · 2008
  • K072951Parietene Duo and Quadra Polypropylene MeshesSofradim Production · 2007
  • K041176Uretex to Trans-Obturator Urethral Support SystemSofradim Production · 2004
  • K033376Ugytex MeshSofradim Production · 2004

More from Feg Textiltechnik Forschungs-Und…

2 FDA decisions under this applicant name. See the company

  • K131530Dynamesh -CicatFeg Textiltechnik Forschungs-Und Entwicklungsgesel · 2013

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/K073579 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073579: Dynamesh-PP Standard, Model PP02NNNN, Dynamesh-PP Light, Model PP01NNNN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073579

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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