# K070894: Tephaflex Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Tepha, Inc.
- Decided: Apr 13, 2007 after 14 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
Longest line of descent: 3 generations back to K002699 (2001). 9 ancestors in all.
17 later devices descend from it; 7 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810428: Vicryl, ETHICON, Inc. (1981) Summary page 1.
- K851086: Vicryl (Polyglactin 910/Mersilene Compoisite Mesh, ETHICON, Inc. (1985) Summary page 1.
- DEN060003: Tephaflex Absorbable Suture, Tepha, Inc. (2007). Our reading of the summary gave K052225, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN060003, Tephaflex Absorbable Suture (Tepha, Inc.), granted Feb 8, 2007; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K031955: Macropore Surgi-Wrap Mast Bioresorbable Sheet, Macropore Biosurgery, Inc. (2003). Our reading of the summary gave K031995, FDA’s number for Comprehensive Neuromuscular Profiler (Medical Technologies Unlimited, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Surgi-Wrap Film”.
- K050332: Surgi-Wrap Mast Bioresorbable Sheet, Mast Biosurgery USA, Inc. (2005) Summary page 1.

## 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
- K093799: Tornier Surgical Mesh (2010), 2 descendants of its own

## Indications for use
TephaFLEX® Surgical Mesh is intended wherever temporary wound support is required, to reinforce soft tissues where weakness exists or 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. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.

Source page: https://510kreport.com/device/K070894
Methodology: https://510kreport.com/methodology