# K092428: Bio-Oss Collagen

- Pathway: 510(k) (Traditional)
- Applicant: Ed. Geistlich Soehne AG Fuer Chemische Industrie
- Decided: Mar 18, 2010 after 223 days
- Product code: NPM (Bone Grafting Material, Animal Source)
- 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: 2 generations back to K871773 (1987). 8 ancestors in all.
29 later devices descend from it; 4 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033815: Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen, Geistlich-Pharma (2004) Summary page 2.
- K974399: Bio-Oss Collagen, Geistlich-Pharma (1998) Summary page 2.

## Most influential descendants
- K112572: Geistlich Combi-Kit Collegen (2011), 23 descendants of its own
- K122894: Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich Perio System Combi Pack, Geistlic (2013), 21 descendants of its own
- K112575: Geistlich Perio-System Combi-Pack , Geistlich Bio-Gide Perio (2011), 11 descendants of its own
- K171643: Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed (2017), 10 descendants of its own
- K192042: Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal (2019), 9 descendants of its own

## Indications for use
Augmentation or reconstructive treatment of alveolar ridge Filling of periodontal defects Filling of defects after root resection, apicoectomy, and cystectomny 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 peni-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

Source page: https://510kreport.com/device/K092428
Methodology: https://510kreport.com/methodology