# K992991: Atrium Medical Corporation Advanta Ptfe Facial Implant

- Pathway: 510(k) (Traditional)
- Applicant: Atrium Medical Corp.
- Decided: Jan 27, 2000 after 142 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.
94 later devices descend from it; 4 cite it directly.
0 of 95 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
- 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
- K082176: LTM-BPS Surgical Mesh (2008), 14 descendants of its own

## Indications for use
The Atrium Advanta™ PTFE Facial Implant is intended for use in Facial Plastic and Reconstructive Surgery.

Source page: https://510kreport.com/device/K992991
Methodology: https://510kreport.com/methodology