# K071555: Fortagen Oral Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Organogenesis, Inc.
- Decided: Aug 30, 2007 after 84 days
- Product code: NPL (Barrier, Animal Source, Intraoral)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K921895 (1992). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021105: Fortaflex Surgical Mesh, Organogenesis, Inc. (2002) Summary page 1.
- K053260: Ossix -Plus, Colbar Lifescience, Ltd. (2006) Summary page 1.
- K050446: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone, Ed. Geistlich Soehne AG Fuer Chemische Industrie (2005) Summary page 1.

## Most influential descendants
- K102307: Genoss Collagen Membrane Model GCM1020, GCM3040 Total 6 Models (2011), 0 descendants of its own

## Indications for use
FortaGen Oral Membrane is intended to be used during guided bone and guided tissue regeneration procedures as a biodegradable barrier membrane for: • Ridge augmentation for later implant insertions; • Simultaneous ridge augmentation and implant insertions; • Ridge augmentation around implants inserted in delayed extraction sites; • Ridge augmentation around implants inserted in immediate extraction sites; • Alveolar ridge preservation consequent to tooth (teeth) extraction(s); • Over the window in lateral window sinus elevation procedures; • In implants with vertical bone loss due to infection, only in cases where satisfactory debridement and implant surface disinfection can be achieved; • In intra bony defects around teeth; • For treatment of recession defects, together with coronally positioned flap; • In furcation defects in multi-rooted teeth.

Source page: https://510kreport.com/device/K071555
Methodology: https://510kreport.com/methodology