# K102788: Tornier Biofiber Scaffold

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: May 10, 2011 after 228 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- 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: 10 generations back to K921895 (1992). 60 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070894: Tephaflex Surgical Mesh, Tepha, Inc. (2007) Summary page 1.
- K093799: Tornier Surgical Mesh, Tornier, Inc. (2010) Summary page 1.

## Most influential descendants
- K111337: Tornier Collagen Coated Biofiber Scaffold (2012), 0 descendants of its own

## Indications for use
Tornier@ BioFiber Scaffold is intended for use where temporary wound support is required to reinforce soft tissues where weakness exists or for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. Tornier® BioFiber Scaffold is intended for reinforcement of soft tissues, in conjunction with sutures and/or suture anchors during tendon repair surgery; including the reinforcement of rotator cuff, patellar, Achilles, biceps and quadriceps tendons. Tornier@ BioFiber Scaffold is not intended for use as a replacement for normal body structures or to provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair.

Source page: https://510kreport.com/device/K102788
Methodology: https://510kreport.com/methodology