# K093799: Tornier Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Apr 22, 2010 after 133 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: 9 generations back to K921895 (1992). 59 ancestors in all.
2 later devices descend from it; 2 cite 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.
- K071887: Sportmesh or Artelon Tissue Reinforcement, Artimplant AB (2007) Summary page 1.
- K071986: LTM-RC Surgical Mesh, Lifecell Corp. (2007) Summary page 1.

## Most influential descendants
- K102788: Tornier Biofiber Scaffold (2011), 1 descendant of its own
- K111337: Tornier Collagen Coated Biofiber Scaffold (2012), 0 descendants of its own

## Indications for use
Tornier® Surgical Mesh is intended for use where temporary wound support is required to reinforce soft tissues where weakness exists or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. Tornier® Surgical Mesh is also 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® Surgical Mesh 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/K093799
Methodology: https://510kreport.com/methodology