# K153549: Ossix Volumax

- Pathway: 510(k) (Traditional)
- Applicant: Datum Dental, Ltd.
- Decided: Aug 4, 2016 after 237 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: 1 generation back to K053260 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053260: Ossix -Plus, Colbar Lifescience, Ltd. (2006) Summary page 4.

## Indications for use
OSSIX® VOLUMAX is a resorbable collagen membrane intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier 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 procedure. - 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. - Localized gingival augmentation.

Source page: https://510kreport.com/device/K153549
Methodology: https://510kreport.com/methodology