# K112567: Biomerix Assure

- Pathway: 510(k) (Traditional)
- Applicant: Biomerix Corporation
- Decided: Dec 23, 2011 after 112 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: 11 generations back to K921895 (1992). 102 ancestors in all.
No later device cites it as a predicate yet.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093123: Biomerix Ventral Hernia Repair Mesh, Model SM3-Tab, Biomerix Corporation (2010) Summary page 1.
- K992991: Atrium Medical Corporation Advanta Ptfe Facial Implant, Atrium Medical Corp. (2000) Summary page 1.
- K013625: Permacol, Tissue Science Laboratories, Plc (2002) Summary page 1.
- K082176: LTM-BPS Surgical Mesh, Lifecell Corp. (2008) Summary page 1.

## Indications for use
Biomerix ASSURE TM is intended for repair and/or reinforcement of soft tissues where weakness exists in plastic and reconstructive surgery. The resorbable protective film minimizes tissue attachment to the device.

Source page: https://510kreport.com/device/K112567
Methodology: https://510kreport.com/methodology