# K163152: PROLENE Soft Polypropylene Mesh

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Mar 11, 2017 after 121 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
Longest line of descent: 1 generation back to K001122 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001122: Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh, ETHICON, Inc. (2000) Summary page 4.

## Most influential descendants
- K172089: PROLENE Soft Polypropylene Mesh (2017), 0 descendants of its own

## Indications for use
Prolene Soft Polypropylene Mesh may be used for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Source page: https://510kreport.com/device/K163152
Methodology: https://510kreport.com/methodology