# K253317: Cytrans™ Elashield

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Jul 6, 2026 after 279 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- 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: 10 generations back to K924408 (1995). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090083: Cytoflex Resorb, Model C03-0010 Through C03-090, Unicare Biomedical, Inc. (2009) Summary page 5.
- K212463: Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack, Geistlich Pharma AG (2022) Summary page 5.

## Indications for use
Cytrans™ Elashield is intended for the following uses as a space-making barrier: Guided bone regeneration in oral surgery Alveolar ridge augmentation Guided tissue regeneration in periodontal defects Extraction socket site preservation Sinus lifts Immediate implant placement at time of extraction or delayed placement Treatment of associated cystic defect The containment of bone grafting materials

Source page: https://510kreport.com/device/K253317
Methodology: https://510kreport.com/methodology