# K962530: Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Aug 9, 1996 after 42 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.
132 later devices descend from it; 6 cite it directly.
0 of 133 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 nonabsorbable synthetic surgical mesh: named in the summary without a submission number

## Most influential descendants
- K002721: Ams Triangle Silicone-Coated Sling and Surgical Mesh (2000), 113 descendants of its own
- K010931: Ams Sacral Colpopexy Sling, Model 72403501 (2001), 80 descendants of its own
- 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

## Indications for use
Modified PROLENE mesh is intended for the repair of hernia and other fascial deficiencies that require the addition of a reinforcing or bridging material.

Source page: https://510kreport.com/device/K962530
Methodology: https://510kreport.com/methodology