# K132348: Tephaflex Braided Suture

- Pathway: 510(k) (Traditional)
- Applicant: Tepha, Inc.
- Decided: Sep 5, 2013 after 38 days
- Product code: NWJ (Suture, Recombinant Technology)
- Device class: 2
- Regulation: 21 CFR 878.4494
- 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 DEN060003 (2007). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K082178: Tephaflex Absorbable Suture, Tepha, Inc. (2008) Summary page 1.
- K122487: Biofiber Syture, Tornier, Inc. (2012) Summary page 1.
- K130422: Phantom Fiber Biofiber Suture, Tornier, Inc. (2013) Summary page 1.
- K930360: Sutures, ETHICON, Inc. (1993) Summary page 1.
- K972566: Dexon Violet, Davis & Geck, Inc. (1997) Summary page 1.
- K022269: Coated Vicryl* (Polyglactin 910) Suture, ETHICON, Inc. (2002) Summary page 1.

## Indications for use
TephaFLEX braided sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Source page: https://510kreport.com/device/K132348
Methodology: https://510kreport.com/methodology