# K083742: Synoss Collagen Synthetic Mineral-Collagen Bone Graft Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Feb 12, 2009 after 58 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). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 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 1.
- K043034: Osteoguide Anorganic Bone Mineral Products, Collagen Matrix, Inc. (2005) Summary page 1.
- K040783: Foundation, Terumo Corp. (2004) Summary page 1.

## Indications for use
Synthetic Mineral - Collagen Bone Graft Matrix 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/K083742
Methodology: https://510kreport.com/methodology