# K102307: Genoss Collagen Membrane Model GCM1020, GCM3040 Total 6 Models

- Pathway: 510(k) (Traditional)
- Applicant: Genoss Co., Ltd.
- Decided: May 4, 2011 after 261 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: 5 generations back to K921895 (1992). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003339: Collagen Periodontal Membrane, Collagen Matrix, Inc. (2001) Summary page 1.
- K071555: Fortagen Oral Membrane, Organogenesis, Inc. (2007) Summary page 1.
- K053260: Ossix -Plus, Colbar Lifescience, Ltd. (2006) Summary page 1.

## Indications for use
GENOSS Collagen Membrane is intended to be used during guided bone and guided tissue regeneration procedures as a biodegradable barrier membrane into bony defects surrounding teeth and on alveolar ridges. - Periodontal/infirabony defects - Ridge augmentation - Extraction sites (implant preparation/placement) - Guided bone regeneration (GBR) procedures - Sinus lifts

Source page: https://510kreport.com/device/K102307
Methodology: https://510kreport.com/methodology