# K192597: Cytrans Granules

- Pathway: 510(k) (Abbreviated)
- Applicant: GC America, Inc.
- Decided: Aug 17, 2020 after 332 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: 4 generations back to K871773 (1987). 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)
- K072397: Synoss Synthetic Bone Graft Material, Collagen Matrix, Inc. (2007) Summary page 5.

## Indications for use
-Augmentation or reconstructive treatment of the alveolar ridge. -Filling of periodontal defects. -Filling of defects after root resection, apicocetomy, and cystectomy. -Filling of extraction sockets to enhance preservation of the alveolar ridge. -Elevation of the maxillary sinus floor. -Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR). -Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Source page: https://510kreport.com/device/K192597
Methodology: https://510kreport.com/methodology