# K973462: Softform Facial Implant

- Pathway: 510(k) (Traditional)
- Applicant: Tissue Technologies, Inc.
- Decided: Nov 24, 1997 after 73 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
No predicates in its family tree.
96 later devices descend from it; 1 cites it directly.
0 of 97 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
For Plastic and Reconstructive Surgery*

Source page: https://510kreport.com/device/K973462
Methodology: https://510kreport.com/methodology