510(k) · Cleared
ClearedOptilene Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Jul 19, 2006 as substantially equivalent to K053158 (Aesculap, Inc., 2006) after a 33-day review. Its family tree reaches back 2 generations to 1996. 4 later devices descend from it.
- Decided
- Jul 19, 2006
- Review
- 33 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K962530 (1996). 3 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK962530 Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical MeshETHICON, Inc. · 1996
- 1 generation backK053158 Optilene Mesh LPAesculap, Inc. · 2006
- This deviceK061704 Optilene MeshAesculap, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK073579 Dynamesh-PP Standard, Model PP02NNNN, Dynamesh-PP Light, Model…Feg Textiltechnik Forschungs-Und Entwicklungsgesel · 2008
- Descendant · 2 generations on · 2 of its ownK131530 Dynamesh -CicatFeg Textiltechnik Forschungs-Und Entwicklungsgesel · 2013
- Descendant · 3 generations on · 1 of its ownK161550 DynaMesh-VENTRALFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft · 2016
- Descendant · 4 generations on · 0 of its ownK182087 DynaMesh-POSTERIORFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft · 2018
Most influential descendants
Showing 4 of 4 · See all- K073579Dynamesh-PP Standard, Model PP02NNNN, Dynamesh-PP Light, Model PP01NNNNFeg Textiltechnik Forschungs-Und Entwicklungsgesel · 2008 · cites it directly3descendants
- K131530Dynamesh -CicatFeg Textiltechnik Forschungs-Und Entwicklungsgesel · 2013 · 2 generations on2descendants
- K161550DynaMesh-VENTRALFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft · 2016 · 3 generations on1descendant
- K182087DynaMesh-POSTERIORFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft · 2018 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962530 | Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh | ETHICON, Inc. | 1996 | — |
| −1 | K053158 | Optilene Mesh LP | Aesculap, Inc. | 2006 | — |
| 0 (this device) | K061704 | Optilene Mesh | Aesculap, Inc. | 2006 | — |
| +1 | K073579 | Dynamesh-PP Standard, Model PP02NNNN, Dynamesh-PP Light, Model PP01NNNN | Feg Textiltechnik Forschungs-Und Entwicklungsgesel | 2008 | — |
| +2 | K131530 | Dynamesh -Cicat | Feg Textiltechnik Forschungs-Und Entwicklungsgesel | 2013 | — |
| +3 | K161550 | DynaMesh-VENTRAL | Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft | 2016 | — |
| +4 | K182087 | DynaMesh-POSTERIOR | Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
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 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K053158 | Optilene Mesh LPSummary page 1…FTL SUBSTANTIAL EQUIVALENCE Aesculap®, Inc. believes that the Optilene® Mesh is substantially equivalent to: * Aesculap Optilene® Mesh LP (K053158) DEVICE DESCRIPTION Optilene® Mesh is a synthetic implantable sheet for the reinforcement of connective tissue structures. It c… | 2006 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073579 | Dynamesh-PP Standard, Model PP02NNNN, Dynamesh-PP Light, Model PP01NNNN | 2008 | 3 |
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 10 years and passes through 2 companies; a new generation was cleared every 9.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K073579 (Feg Textiltechnik Forschungs-Und Entwicklungsgesel, 2008) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Optilene Meshes (Standard, Universal, and Elastic) are indicated for hemioplasty and repair of other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061704 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061704: Optilene Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061704
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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