# K130326: Tephaflex Meltblown Construct

- Pathway: 510(k) (Traditional)
- Applicant: Tepha, Inc.
- Decided: May 7, 2013 after 88 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: 7 generations back to K842066 (1985). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113723: Tephaflex Mesh, Tepha, Inc. (2012) Summary page 1.
- K062696: Surgisis, Surgisis ES, Cook Biotech, Inc. (2006) Summary page 1.
- K033671: Gore Bioabsorbable Mesh, W. L. Gore & Associates, Inc. (2003) Summary page 1.
- 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, “MAST Biosurgery Surgi-Wrap”.
- K050332: Surgi-Wrap Mast Bioresorbable Sheet, Mast Biosurgery USA, Inc. (2005) Summary page 1.

## Indications for use
TephaFLEX Melt blown Matrix is intended to reinforce soft tissue where weakness exists in patients undergoing surgical procedures that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Source page: https://510kreport.com/device/K130326
Methodology: https://510kreport.com/methodology