# K042603: Gynecare Prolene Fastener System

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Dec 22, 2004 after 89 days
- Product code: PBQ (Fixation, Non-Absorbable Or Absorbable,  For Pelvic Use)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 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) ETHIBOND EXCEL suture: named in the summary without a submission number
- (no number) ETHICON PROLENE suture: named in the summary without a submission number

## Most influential descendants
- K120831: Anchorsure (2012), 5 descendants of its own
- K160569: NeuGuide (2016), 3 descendants of its own
- K213783: Apyx (2022), 2 descendants of its own
- K230730: Apyx (2023), 1 descendant of its own
- K260380: Mendit (2026), 0 descendants of its own

## Indications for use
The GYNECARE PROLENE Fastener System is indicated for the attachment of knitted, non-woven surgical mesh and suture to ligaments of the pelvic floor.

Source page: https://510kreport.com/device/K042603
Methodology: https://510kreport.com/methodology