# K081561: Osferion D

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Terumo Biomaterials Corporation
- Decided: Jul 28, 2008 after 55 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 K941780 (1995). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051443: Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio, Curasan Ag, Frankfurt Facility (2005) Summary page 2.
- K050260: Bioresorb Macro Pore, Oraltronics Dental Implant Technology GmbH (2005) Summary page 2.

## Most influential descendants
- K091618: Vitomatrix (2010), 0 descendants of its own

## Indications for use
It 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 peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Source page: https://510kreport.com/device/K081561
Methodology: https://510kreport.com/methodology