# K091618: Vitomatrix

- Pathway: 510(k) (Traditional)
- Applicant: Orthovita, Inc.
- Decided: Sep 27, 2010 after 481 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: 5 generations back to K941780 (1995). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081561: Osferion D, Olympus Terumo Biomaterials Corporation (2008) Summary page 1.
- K051443: Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio, Curasan Ag, Frankfurt Facility (2005) Summary page 1.

## Indications for use
VITOMATRIX is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. * Augmentation or reconstructive treatment of the alveolar ridge. * Filling of infrabony periodontal defects. * Filling of defects after root resection, apicoectomy, 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 peni-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Source page: https://510kreport.com/device/K091618
Methodology: https://510kreport.com/methodology