# K113723: Tephaflex Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Tepha, Inc.
- Decided: Feb 15, 2012 after 58 days
- Product code: OOD (Surgical Film)
- 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
No predicates in its family tree.
14 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TephaFLEX® Surgical Mesh: named in the summary without a submission number
- (no number) TephaFLEX® Composite Mesh: named in the summary without a submission number
- (no number) SupraMesh: named in the summary without a submission number

## Most influential descendants
- K143380: Phasix ST Mesh (2015), 4 descendants of its own
- K142818: Phasix Mesh (2015), 3 descendants of its own
- K140533: Galaflex Mesh (2014), 3 descendants of its own
- K161424: Phasix Mesh (2016), 2 descendants of its own
- K191749: TIGR Matrix Surgical Mesh, TIGR Surgical Mesh (2020), 1 descendant of its own

## Indications for use
TephaFLEX mesh is intended to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Source page: https://510kreport.com/device/K113723
Methodology: https://510kreport.com/methodology