# K994328: Sepramesh Biosurgical Composite, Model SMBC-XXX

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Corp.
- Decided: Mar 2, 2000 after 71 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 K971745 (1997). 1 ancestor in all.
35 later devices descend from it; 2 cite it directly.
0 of 37 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 2.
- (no number) Bard® Mesh: named in the summary without a submission number
- (no number) Mersilene™ Mesh: named in the summary without a submission number

## Most influential descendants
- K040868: Sepramesh IP Bioresorbable Barrier - Permanent Mesh (2004), 34 descendants of its own
- K053066: Sepramesh IP Bioresorbable Coating/Permanent Mesh (2005), 17 descendants of its own
- K063739: Sepramesh, Model 5959-1214 (2007), 16 descendants of its own
- K062915: Veritas Collagen Matrix (2006), 15 descendants of its own
- K101851: Ventralight ST Mesh (2010), 10 descendants of its own

## Indications for use
Sepramesh™ Biosurgical Composite is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

Source page: https://510kreport.com/device/K994328
Methodology: https://510kreport.com/methodology