# K063739: Sepramesh, Model 5959-1214

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Corporation
- Decided: Jan 17, 2007 after 30 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: 4 generations back to K971745 (1997). 7 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053066: Sepramesh IP Bioresorbable Coating/Permanent Mesh, Genzyme Corporation (2005) Summary page 2.

## Most influential descendants
- K101851: Ventralight ST Mesh (2010), 10 descendants of its own
- K110820: Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System (2011), 5 descendants of its own
- K143380: Phasix ST Mesh (2015), 4 descendants of its own
- K122436: Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS Positioning System (2012), 4 descendants of its own
- K130968: Ventralight ST Mesh with Echo PS Positioning System (2013), 3 descendants of its own

## Indications for use
Sepramesh TM IP Bioresorbable Coating - Permanent Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

Source page: https://510kreport.com/device/K063739
Methodology: https://510kreport.com/methodology