510(k) Report

510(k) · Cleared

Cleared

DynaMesh-POSTERIOR

K182087510(k) TraditionalCleared Oct 31, 201890-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 Entwicklungsgesellschaft · FTL Mesh, Surgical, Polymeric

Cleared on Oct 31, 2018 as substantially equivalent to K161550 (Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft, 2016) after a 90-day review. Its family tree reaches back 6 generations to 1996.

Decided
Oct 31, 2018
Review
90 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to K962530 (1996). 14 ancestors in all, the oldest K792281 (1979). No later device cites it as a predicate yet.

  1. Root · 6 generations backK962530 Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical MeshETHICON, Inc. · 1996
  2. 5 generations backK053158 Optilene Mesh LPAesculap, Inc. · 2006
  3. 4 generations backK061704 Optilene MeshAesculap, Inc. · 2006
  4. 3 generations backK073579 Dynamesh-PP Standard, Model PP02NNNN, Dynamesh-PP Light, Model…Feg Textiltechnik Forschungs-Und Entwicklungsgesel · 2008
  5. 2 generations backK131530 Dynamesh -CicatFeg Textiltechnik Forschungs-Und Entwicklungsgesel · 2013
  6. 1 generation backK161550 DynaMesh-VENTRALFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft · 2016
  7. This deviceK182087 DynaMesh-POSTERIORFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K962530Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical MeshETHICON, Inc.1996—
−5K053158Optilene Mesh LPAesculap, Inc.2006—
−4K061704Optilene MeshAesculap, Inc.2006—
−3K073579Dynamesh-PP Standard, Model PP02NNNN, Dynamesh-PP Light, Model PP01NNNNFeg Textiltechnik Forschungs-Und Entwicklungsgesel2008—
−2K131530Dynamesh -CicatFeg Textiltechnik Forschungs-Und Entwicklungsgesel2013—
−1K161550DynaMesh-VENTRALFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft2016—
0 (this device)K182087DynaMesh-POSTERIORFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
199210
199310
199910
200020
200310
200710
FIG. 1 — Lineage of K182087, 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K161550DynaMesh-VENTRAL
Summary page 5
…sed to Demonstrate Substantial Equivalence: The FEG Textiltechnik DynaMesh®-POSTERIOR is substantially equivalent to: Product Name: DynaMesh®-VENTRAL, K161550 Manufacturer: FEG Textiltechnik, Aachen, Germany Description, including Intended Use DynaMesh®- POSTERIOR serv…
Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft2016—

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 22 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
  • 1 of the 14 ancestors has a recall of any class.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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®- POSTERIOR serves to support the tissue and stabilize the fascial structures of the abdominal wall.

DynaMesh®- POSTERIOR is indicated for repairing hernias in all current extraperitoneal surgical techniques.

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

Cite this page

510(k) Report. “K182087: DynaMesh-POSTERIOR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182087

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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