# K053260: Ossix -Plus

- Pathway: 510(k) (Traditional)
- Applicant: Colbar Lifescience, Ltd.
- Decided: Feb 22, 2006 after 92 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
No predicates in its family tree.
14 later devices descend from it; 9 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Bio-Bar: named in the summary without a submission number
- (no number) Bio-Gide Resorbable Bilayer Membrane: named in the summary without a submission number
- (no number) OSSIX: named in the summary without a submission number

## Most influential descendants
- K101453: Vitala Natural Resorbable Collagen Membrane (2011), 4 descendants of its own
- K141177: Vitala Porcine Derived Collagen Membrane (2015), 3 descendants of its own
- K173562: Straumann Jason Membrane (2018), 2 descendants of its own
- K160281: Ossix Plus (2016), 1 descendant of its own
- K071555: Fortagen Oral Membrane (2007), 1 descendant of its own

## Indications for use
OssixTM-PLUS biodegradable collagen membrane is 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 procedures. In implants with vertical bone loss due to infection, only in cases where satisfactory debridment 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/K053260
Methodology: https://510kreport.com/methodology