# K101287: Tephaflex Composite Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Tepha, Inc.
- Decided: Aug 30, 2010 after 115 days
- Product code: OWT (Mesh, Surgical, Absorbable, Abdominal Hernia)
- 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 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 Film: named in the summary without a submission number
- (no number) TephaFLEX Surgical Mesh: named in the summary without a submission number

## Most influential descendants
- K140533: Galaflex Mesh (2014), 3 descendants of its own
- K161092: GalaSHAPE 3D (2016), 1 descendant of its own
- K202425: SurgiLattice scaffold (2021), 0 descendants of its own
- K162922: GalaFORM 3D (2017), 0 descendants of its own

## Indications for use
TephaFLEX® Composite Mesh is intended wherever temporary wound support is required, to reinforce soft tissues where weakness exists or for the repair of hemia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: repair of colon and rectal prolapse (excluding rectocele) using an abdominal approach, sacral colposuspension and reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapsed). The film side of the device may help minimize the potential for tissue attachment to the mesh in case of direct contact with the viscera.

Source page: https://510kreport.com/device/K101287
Methodology: https://510kreport.com/methodology