510(k) · Cleared
ClearedModification of Prolene (Polypropylene) Hernia System, Nonabsorbable 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 Feb 23, 1999 after a 90-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Feb 23, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK984220 Modification of Prolene (Polypropylene) Hernia System, Nonabsorbable…ETHICON, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK180829 PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh…ETHICON, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK113552 Freedom Inguinal Hernia ImplantInsightra Medical · 2012
- Descendant · 2 generations on · 0 of its ownK191545 Exogenesis Hernia MeshExogenesis Corporation · 2019
- Descendant · cites it directly · 0 of its ownK172395 Duatene bilayer meshSofradim Production · 2018
- Descendant · cites it directly · 0 of its ownK140967 Freedom Inguinal Hernia Repair Implant-25MM/40MM/40MM with Extended…Insightra Medical · 2014
Most influential descendants
Showing 5 of 5 · See all- K180829PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE…ETHICON, Inc. · 2018 · cites it directly1descendant
- K113552Freedom Inguinal Hernia ImplantInsightra Medical · 2012 · cites it directly1descendant
- K191545Exogenesis Hernia MeshExogenesis Corporation · 2019 · 2 generations on0descendants
- K172395Duatene bilayer meshSofradim Production · 2018 · cites it directly0descendants
- K140967Freedom Inguinal Hernia Repair Implant-25MM/40MM/40MM with Extended DiskInsightra Medical · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984220 | Modification of Prolene (Polypropylene) Hernia System, Nonabsorbable Synthetic… | ETHICON, Inc. | 1999 | — |
| +1 | K180829 | PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE… | ETHICON, Inc. | 2018 | — |
| +1 | K113552 | Freedom Inguinal Hernia Implant | Insightra Medical | 2012 | — |
| +2 | K191545 | Exogenesis Hernia Mesh | Exogenesis Corporation | 2019 | — |
| +1 | K172395 | Duatene bilayer mesh | Sofradim Production | 2018 | — |
| +1 | K140967 | Freedom Inguinal Hernia Repair Implant-25MM/40MM/40MM with Extended Disk | Insightra Medical | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | PROLENE* (Polypropylene) Hernia System Named without a submission number |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K180829 (ETHICON, Inc., 2018) has gone furthest, with 1 descendant 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?
The PROLENE (Polypropylene) Hernia System is indicated for the repair of abdominal wall hernia defects.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984220 · printed Nov 5, 2026
Cite this page
510(k) Report. “K984220: Modification of Prolene (Polypropylene) Hernia System, Nonabsorbable Synthetic Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984220
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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