# K081327: Relimesh

- Pathway: 510(k) (Traditional)
- Applicant: Herniamesh S.R.L.
- Decided: Jun 19, 2008 after 38 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: 8 generations back to K921895 (1992). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971745: Bard Composite Prosthesis, Davol Inc., Sub. C. R. Bard, Inc. (1997) Summary page 1.
- K070625: Pelvimesh / Hermesh 7, Marketing Solutions, Inc. (2007) Summary page 1.

## Indications for use
Relimesh prostheses are intended for use in the reconstruction of soft tissue deficiencies such as but not limited to hernia repairs and chest wall defects.

Source page: https://510kreport.com/device/K081327
Methodology: https://510kreport.com/methodology