# K043081: Gore Polypropylene Hernia Mesh

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Dec 22, 2004 after 44 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). 2 ancestors in all.
26 later devices descend from it; 1 cites it directly.
0 of 29 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 2.
- K002093: Atrium Lite Mesh, Atrium Medical Corp. (2000) Summary page 2.
- (no number) Bard® Mesh: named in the summary without a submission number

## Most influential descendants
- K052864: Tyrx Surgical Mesh, Model SMPC-0501 (2005), 25 descendants of its own
- K053656: Tyrx Antimicrobial Mesh (2006), 24 descendants of its own
- K063091: Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601 (2008), 17 descendants of its own
- K130943: Aigis RX R PM/ Aigis RX R Icd (2013), 14 descendants of its own
- K131007: Aigis RX N Medium; Aigis RX N Large (2013), 6 descendants of its own

## Indications for use
The GORE POLYPROPYLENE Hernia Mesh is a sterile, non-absorbable, knitted polypropylene monofilament mesh intended for the reconstruction of hernias and soft tissue deficiencies. Examples of applications where the GORE® POLYPROPYLENE HERNIA MESH may be used include, but are not limited to: Hernia repair (inguinal, femoral, umbilical, abdominal, incisional, epigastric, and intermuscular). Muscle flap reinforcement

Source page: https://510kreport.com/device/K043081
Methodology: https://510kreport.com/methodology