510(k) · Cleared
ClearedPROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Jun 28, 2018 as substantially equivalent to K962530 (ETHICON, Inc., 1996) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Jun 28, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K962530 (1996). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK962530 Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical MeshETHICON, Inc. · 1996
- This deviceK180829 PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh…ETHICON, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK191545 Exogenesis Hernia MeshExogenesis Corporation · 2019
Most influential descendants
Showing 1 of 1 · See all- K191545Exogenesis Hernia MeshExogenesis Corporation · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962530 | Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh | ETHICON, Inc. | 1996 | — |
| 0 (this device) | K180829 | PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE… | ETHICON, Inc. | 2018 | — |
| +1 | K191545 | Exogenesis Hernia Mesh | Exogenesis Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K962530 | Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical MeshSummary page 5…Product 510(k) Device Company Predicate for Code Number PROLENE™ Ethicon, FTL K962530 Fundamental Scientific Polypropylene Inc. Technology, Design, Mesh… | 1996 |
| * | K984220 | Modification of Prolene (Polypropylene) Hernia System, Nonabsorbable Synthetic Surgical…Summary page 5…Product 510(k) Device Company Predicate for Code Number Modification of Ethicon, FTL K984220 Fundamental Scientific PROLENE™ Inc. Technology, Design, (Polypropylene)… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191545 | Exogenesis Hernia Mesh | 2019 | 0 |
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?
How does its category compare?
All FTL devicesFTL 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
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?
PROLENE™ Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.
The PROLENE™ Hernia System is indicated for the repair of abdominal wall hernia defects, including inguinal (direct & indirect).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180829 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180829: PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180829
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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