# K984220: Modification of Prolene (Polypropylene) Hernia System, Nonabsorbable Synthetic Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Feb 23, 1999 after 90 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) PROLENE* (Polypropylene) Hernia System: named in the summary without a submission number

## Most influential descendants
- K180829: PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh (2018), 1 descendant of its own
- K113552: Freedom Inguinal Hernia Implant (2012), 1 descendant of its own
- K191545: Exogenesis Hernia Mesh (2019), 0 descendants of its own
- K172395: Duatene bilayer mesh (2018), 0 descendants of its own
- K140967: Freedom Inguinal Hernia Repair Implant-25MM/40MM/40MM with Extended Disk (2014), 0 descendants of its own

## Indications for use
The PROLENE (Polypropylene) Hernia System is indicated for the repair of abdominal wall hernia defects.

Source page: https://510kreport.com/device/K984220
Methodology: https://510kreport.com/methodology