# K113311: TIO2MESH TM

- Pathway: 510(k) (Traditional)
- Applicant: Biocer Entwicklungs GmbH
- Decided: Jul 17, 2012 after 251 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 K031225 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031225: Timesh Also Known as Timesh-TC, Models 6000001 & 6000004, Gfe Medizintechnik GmbH (2003) Summary page 2.
- K052155: Bard Large Pore Soft Mesh and Soft Mesh Preshaped, C.R. Bard, Inc. (2005) Summary page 2.

## Indications for use
TiO2 Mesh M is a surgical mesh implant specifically indicated for repair of tissue defects of the abdominal wall, where a non-reabsorbable support material is required. Relevant applications include the repair of inguinal and incisional hernia in all common surgical methods. TiO2Mesh can be used for both laparoscopic and other open procedures.

Source page: https://510kreport.com/device/K113311
Methodology: https://510kreport.com/methodology