# K053066: Sepramesh IP Bioresorbable Coating/Permanent Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Corporation
- Decided: Dec 19, 2005 after 48 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: 3 generations back to K971745 (1997). 6 ancestors in all.
17 later devices descend from it; 4 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)
- K040868: Sepramesh IP Bioresorbable Barrier - Permanent Mesh, Genzyme Corp. (2004) Summary page 1.
- K994328: Sepramesh Biosurgical Composite, Model SMBC-XXX, Genzyme Corp. (2000) Summary page 1.
- K002684: Composix E/X Mesh, C.R. Bard, Inc. (2000) Summary page 2.
- K810428: Vicryl, ETHICON, Inc. (1981) Summary page 2.
- K830889: Dexon 'S' Polyglycolic Acid Mesh, Davis & Geck, Inc. (1983) Summary page 2.
- (no number) Bard Mesh: named in the summary without a submission number

## Most influential descendants
- K063739: Sepramesh, Model 5959-1214 (2007), 16 descendants of its own
- 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

## Indications for use
Sepramesh TM IP Bioresorbable Barrier - 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/K053066
Methodology: https://510kreport.com/methodology