# K141177: Vitala Porcine Derived Collagen Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Osteogenics Biomedical, Inc. (Formerly Obi Biologi
- Decided: Sep 15, 2015 after 496 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 K924408 (1995). 8 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101453: Vitala Natural Resorbable Collagen Membrane, Obi Biologics, Inc. (2011) Summary page 4.

## Most influential descendants
- K173562: Straumann Jason Membrane (2018), 2 descendants of its own
- K242817: Jason membrane (2025), 0 descendants of its own
- K223912: InterCollagen® Guide (2023), 0 descendants of its own

## Indications for use
Vitala Porcine Derived Collagen Membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for: -Simultaneous use with implants; -Augmentation around implants placed in immediate extraction sockets; -Augmentation around implants placed in delayed extraction sockets; -Localized ridge augmentation for later implantation; -Alveolar ridge reconstruction for prosthetic treatment; -Alveolar ridge preservation consequent to tooth extraction; -Filling of bone defects after root resection, cystectomy, removal of retained teeth; -Over the window in lateral window sinus elevation procedures; -Furcation defects in multi-rooted teeth; -Treatment of recession defects, together with coronally positioned flap; -In implants with vertical bone loss due to infection, only with satisfactory debridement and implant surface disinfection; -Guided bone regeneration in dehiscence defects; and -Guided tissue regeneration in periodontal defects.

Source page: https://510kreport.com/device/K141177
Methodology: https://510kreport.com/methodology