# K130422: Phantom Fiber Biofiber Suture

- Pathway: 510(k) (Special)
- Applicant: Tornier, Inc.
- Decided: Apr 4, 2013 after 43 days
- Product code: NWJ (Suture, Recombinant Technology)
- Device class: 2
- Regulation: 21 CFR 878.4494
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN060003 (2007). 4 ancestors in all.
1 later device descends from it; 1 cites 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)
- K122487: Biofiber Syture, Tornier, Inc. (2012) Summary page 2.

## Most influential descendants
- K132348: Tephaflex Braided Suture (2013), 0 descendants of its own

## Recalls of this device
- Feb 8, 2018 · Class II · Z-1374-2018: Data has shown that degradation of a raw material used in Phantom Fiber may occur more quickly than expected if improperly stored. This may impact the shelf-life of the product which could cause the s

## Indications for use
Phantom Fiber 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/K130422
Methodology: https://510kreport.com/methodology