# K001122: Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: May 23, 2000 after 46 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.
152 later devices descend from it; 13 cite it directly.
0 of 153 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) Mesh: named in the summary without a submission number
- (no number) MERSILENE* Mesh: named in the summary without a submission number

## Most influential descendants
- K033636: Ams Large Pore Polypropylene Mesh (2003), 79 descendants of its own
- K040521: Modification to Ams Large Pore Polypropylene Mesh (2004), 74 descendants of its own
- K040623: Ams Perigee System (2004), 70 descendants of its own
- K040537: Ams Apogee Vault Suspension System (2004), 70 descendants of its own
- K050445: Ams Collagen Dermal Matrix (2005), 30 descendants of its own

## Indications for use
The PROLENE, Soft (Polypropylene) Mesh is indicated 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/K001122
Methodology: https://510kreport.com/methodology