# K080216: Supramesh Extra

- Pathway: 510(k) (Traditional)
- Applicant: S. Jackson, Inc.
- Decided: Sep 15, 2008 after 230 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: 1 generation back to K831723 (1983). 3 ancestors in all.
2 later devices descend 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)
- K831723: Supramid Extra Surgical Mesh, S. Jackson, Inc. (1983) Summary page 2.
- K852011: Nylamid Mesh Pad Full & Half, S. Jackson, Inc. (1985) Summary page 2.
- K831724: Chin (Mentoplasty) Implants, S. Jackson, Inc. (1983) Summary page 2.

## Most influential descendants
- K083102: Refine Lift System (2009), 1 descendant of its own
- K092538: Refine Support System, Model 100.0100 (2010), 0 descendants of its own

## Indications for use
SupraMESH EXTRATM nylon mesh is indicated for use as a hernia mesh and for plastic and reconstructive surgery.

Source page: https://510kreport.com/device/K080216
Methodology: https://510kreport.com/methodology