# K181094: Polydioxanone Surgical Scaffold

- Pathway: 510(k) (Traditional)
- Applicant: Lntegra Lifesciences
- Decided: Aug 2, 2018 after 99 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: 3 generations back to K851086 (1985). 5 ancestors in all.
1 later device descends from it; 1 cites 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)
- K163005: TIGR Matrix Surgical Mesh, Novus Scientific AB (2017) Summary page 4.
- K092224: Tigr Surgical Mesh , Model WK-6, Novus Scientific Pte, Ltd. (2010) Summary page 4.

## Most influential descendants
- K260474: Liora Monofilament Scaffold (2026), 0 descendants of its own

## Indications for use
Polydioxanone Surgical Scaffold is indicated for use in reinforcement of soft tissue where weakness exists.

Source page: https://510kreport.com/device/K181094
Methodology: https://510kreport.com/methodology