# K082941: Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215

- Pathway: 510(k) (Traditional)
- Applicant: Biomerix Corporation
- Decided: Jan 7, 2009 after 97 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: 9 generations back to K921895 (1992). 63 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001122: Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh, ETHICON, Inc. (2000)
- K070961: Biomerix Surgical Mesh, Model: RCR-01, Biomerix Corporation (2008) Summary page 1.
- K061754: Bard Composite L/P Mesh, Davol Inc., Sub. C. R. Bard, Inc. (2006) Summary page 1.
- K992189: Gore-Tex Dualmesh Biomaterial, W. L. Gore & Associates, Inc. (1999) Summary page 1.
- K042592: Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone, Model 72403304, American Medical Systems, Inc. (2004) Summary page 1.
- (no number) Ethicon Mersilene Polyester Fiber Mesh: named in the summary without a submission number

## Most influential descendants
- K093123: Biomerix Ventral Hernia Repair Mesh, Model SM3-Tab (2010), 1 descendant of its own
- K112499: Biomerix Composite Surgical Mesh (2011), 0 descendants of its own
- K112567: Biomerix Assure (2011), 0 descendants of its own

## Indications for use
Biomerix Composite Surgical Mesh is intended to assist in the repair and/or reinforcement of hernia and other soft tissue defects requiring additional support of a nonabsorbable implant during and after wound healing.

Source page: https://510kreport.com/device/K082941
Methodology: https://510kreport.com/methodology