510(k) · Cleared
ClearedTIO2MESH TM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocer Entwicklungs GmbH · FTL Mesh, Surgical, Polymeric
Cleared on Jul 17, 2012 as substantially equivalent to K031225 (Gfe Medizintechnik GmbH, 2003) and 1 other predicate after a 251-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Jul 17, 2012
- Review
- 251 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K031225 (2003). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK031225 Timesh Also Known as Timesh-TC, Models 6000001 & 6000004Gfe Medizintechnik GmbH · 2003
- This deviceK113311 TIO2MESH TMBiocer Entwicklungs GmbH · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031225 | Timesh Also Known as Timesh-TC, Models 6000001 & 6000004 | Gfe Medizintechnik GmbH | 2003 | — |
| 0 (this device) | K113311 | TIO2MESH TM | Biocer Entwicklungs GmbH | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FTL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031225 | Timesh Also Known as Timesh-TC, Models 6000001 & 6000004Summary page 2…GmbH GmbH Trade Name Ti02 Mesh TiMesh-TC Soft Mesh 510(k) Number Not Available yet K031225 K(052155 Product Code FTL FTI. FTL Regulation 878.3… | 2003 |
| * | K052155 | Bard Large Pore Soft Mesh and Soft Mesh PreshapedSummary page 2…GmbH Trade Name Ti02 Mesh TiMesh-TC Soft Mesh 510(k) Number Not Available yet K031225 K(052155 Product Code FTL FTI. FTL Regulation 878.3300 878.3300… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K031225.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113311: TIO2MESH TM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113311
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026