# K973955: Herniamesh Surgical Meshes

- Pathway: 510(k) (Traditional)
- Applicant: Herniamesh
- Decided: May 11, 1998 after 207 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.
2 later devices descend 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)
- None. The FDA summary names its predicate without a number.
- (no number) Trelex mesh: named in the summary without a submission number
- (no number) Marlex Mesh: named in the summary without a submission number
- (no number) Marlex Mesh Dart: named in the summary without a submission number

## Most influential descendants
- K070625: Pelvimesh / Hermesh 7 (2007), 1 descendant of its own
- K081327: Relimesh (2008), 0 descendants of its own

## Indications for use
All meshes made by Hemiamesh are made of raonofilament polypropylene. The meshes are non biodegradable and highly permeable. The meshes are designed to be used in the surgical repair of abdominal wall hernias such as primary or recurrent inguinal hemias, femoral hermias, inscisional hernias as well as thoracic wall defects. Esch of the Herniamesh products were designed with specific characteristics for each of the different types of hemioplasty. (please refer to product pamphiet )

Source page: https://510kreport.com/device/K973955
Methodology: https://510kreport.com/methodology