# K973379: Sterile Suprafoil Smooth Nylon Foil Sheets

- Pathway: 510(k) (Traditional)
- Applicant: S. Jackson, Inc.
- Decided: Sep 25, 1997 after 17 days
- Product code: FTM (Mesh, Surgical)
- 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
No predicates in its family tree.
106 later devices descend from it; 3 cite it directly.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K013625: Permacol (2002), 95 descendants of its own
- K034039: Sis Plastic Surgery Matrix (2004), 93 descendants of its own
- K070560: LRTM Surgical Mesh (2007), 50 descendants of its own
- K060829: Cosmatrix (2006), 18 descendants of its own
- K071807: Orthomend Soft Tissue Matrix (2007), 17 descendants of its own

## Indications for use
The Foil is intended for use by surgeons only where indicated for plastic and reconstructive surgery. The most widespread and standard use presently is for repair of orbital floor blow-out fractures in the eye. Its use is detailed in articles by Orkan Stasior, M.D., Merrill J. Reeh and James Tsujimura, M.D., J. Emery, M.D., G. von Noorden, M.D., and Donald Schlernitzauer, M.D. The foil is also used in Tympanoplasty in the middle ear as reference in...(the) article by James L. Sheehy, M.D. It has also been used to separate nerves and tendons from surrounding tissue to prevent adhesions during healing and then removed after healing is complete. It has been used to repair or replace dura matter in the skull, and in heavier thicknesses it has been attched to bones to give added strength where necessary.

Source page: https://510kreport.com/device/K973379
Methodology: https://510kreport.com/methodology