# K092224: Tigr Surgical Mesh , Model WK-6

- Pathway: 510(k) (Traditional)
- Applicant: Novus Scientific Pte, Ltd.
- Decided: Jan 25, 2010 after 186 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- 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: 1 generation back to K851086 (1985). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001122: Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh, ETHICON, Inc. (2000)
- K851086: Vicryl (Polyglactin 910/Mersilene Compoisite Mesh, ETHICON, Inc. (1985) Summary page 1.
- K033337: Ultrapro Mesh, ETHICON, Inc. (2004) Summary page 1.

## Most influential descendants
- K163005: TIGR Matrix Surgical Mesh (2017), 2 descendants of its own
- K181094: Polydioxanone Surgical Scaffold (2018), 1 descendant of its own
- K260474: Liora Monofilament Scaffold (2026), 0 descendants of its own

## Recalls of this device
- Jul 19, 2016 · Class II · Z-2603-2016: Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs.

## Indications for use
TIGR Matrix Surgical Mesh is indicated for use in reinforcement of soft tissue where weakness exists.

Source page: https://510kreport.com/device/K092224
Methodology: https://510kreport.com/methodology