# K072397: Synoss Synthetic Bone Graft Material

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Oct 18, 2007 after 52 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: 3 generations back to K871773 (1987). 9 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043034: Osteoguide Anorganic Bone Mineral Products, Collagen Matrix, Inc. (2005) Summary page 1.

## Most influential descendants
- K192597: Cytrans Granules (2020), 0 descendants of its own
- K090793: Bongros HA (2009), 0 descendants of its own
- K083742: Synoss Collagen Synthetic Mineral-Collagen Bone Graft Matrix (2009), 0 descendants of its own

## Indications for use
SynOss Synthetic Bone Graft Material is intended for use in dental surgery. The products may be used in surgical procedures such as: * Augmentation or reconstructive treatment of alveolar ridge * Filling of periodontal defects * Filling of defects after root resection, apicocectomy, and cystectomy * Filling of extraction sockets to enhance preservation of the alveolar ridge * Elevation of 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

Source page: https://510kreport.com/device/K072397
Methodology: https://510kreport.com/methodology