# K122487: Biofiber Syture

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Sep 17, 2012 after 33 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: 1 generation back to DEN060003 (2007). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 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.
- K081099: Tephaflex Absorbable Suture, Tepha, Inc. (2008) Summary page 2.
- K082178: Tephaflex Absorbable Suture, Tepha, Inc. (2008) Summary page 2.

## Most influential descendants
- K130422: Phantom Fiber Biofiber Suture (2013), 1 descendant of its own
- K132348: Tephaflex Braided Suture (2013), 0 descendants of its own

## Indications for use
BioFiber Suture is 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/K122487
Methodology: https://510kreport.com/methodology