# K070738: Sis Facial Cylinder, Sis Facial Implant

- Pathway: 510(k) (Special)
- Applicant: Cook Biotech, Inc.
- Decided: Apr 5, 2007 after 20 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K110402: Biodesign Nipple Reconstruction Cylinder (2011), 0 descendants of its own

## Indications for use
The SIS Facial Implant is intended for use to provide soft tissue repair or reinforcement in plastic and reconstructive surgery of the face and head. The device is supplied sterile and is intended for one-time use.

Source page: https://510kreport.com/device/K070738
Methodology: https://510kreport.com/methodology