# K242817: Jason membrane

- Pathway: 510(k) (Traditional)
- Applicant: Botiss Biomaterials GmbH
- Decided: Dec 12, 2025 after 450 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: 7 generations back to K924408 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173562: Straumann Jason Membrane, Institut Straumann AG (2018) Summary page 5.

## Indications for use
Jason membrane alone or in combination with suitable augmentation materials (like autogenous bone, allogeneic, xenogeneic or alloplastic bone replacement materials) is indicated for immediate or delayed guided tissue and bone regeneration. - in case of surgical bone defects and bone wall defects - in the context of sinus floor augmentation and for support of the Schneiderian membrane - in the context of maxillary ridge augmentation - in the context of maxillary ridge reconstruction for prosthetic treatment - in the context of a treatment of fenestration defects - in case of periodontal bone defects (one to three-wall defects, class I and II furcation defects) - in case of dehiscence defects - after apicoectomy, cystectomy, resection of retained teeth and resection of other bone lesions - in extraction sockets after tooth extractions - in case of immediate or delayed augmentation around implants in extraction sockets

Source page: https://510kreport.com/device/K242817
Methodology: https://510kreport.com/methodology