# K063154: Facial Reconstructive Mesh (FRM)

- Pathway: 510(k) (Traditional)
- Applicant: Evera Medical, Inc.
- Decided: Jul 10, 2007 after 267 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: 2 generations back to K973379 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851086: Vicryl (Polyglactin 910/Mersilene Compoisite Mesh, ETHICON, Inc. (1985) Summary page 1.
- K013625: Permacol, Tissue Science Laboratories, Plc (2002) Summary page 1.
- K952898: Gore-Tex Sam Facial Implant with Introducer, W. L. Gore & Associates, Inc. (1995) Summary page 1.
- K971745: Bard Composite Prosthesis, Davol Inc., Sub. C. R. Bard, Inc. (1997) Summary page 2.

## Indications for use
The Facial Reconstructive Mesh is intended for use in plastic and reconstructive surgery of the face and head to provide soft tissue repair or reinforcement.

Source page: https://510kreport.com/device/K063154
Methodology: https://510kreport.com/methodology