# K201241: Striate+™

- Pathway: 510(k) (Traditional)
- Applicant: Orthocell, Ltd.
- Decided: Jan 11, 2021 after 248 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: 3 generations back to K924408 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042197: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration, Ed. Geistlich Soehne AG Fuer Chemische Industrie (2004) Summary page 4.

## Indications for use
Striate+TM is indicated for use in: - augmentation around implants placed in immediate extraction sockets - augmentation around implants placed in delayed extraction sockets - filling of bone defects after root resection or removal of retained teeth - guided bone regeneration in dehiscence defects; and - guided tissue regeneration procedures in intrabony periodontal defects

Source page: https://510kreport.com/device/K201241
Methodology: https://510kreport.com/methodology