# K240661: Geistlich Bio-Oss®

- Pathway: 510(k) (Traditional)
- Applicant: Geistlich Pharma AG
- Decided: Jul 12, 2024 after 126 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: 6 generations back to K924408 (1995). 16 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122894: Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich Perio System Combi Pack, Geistlic, Geistlich Pharma AG (2013) Summary page 5.

## Most influential descendants
- K251786: Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® (2025), 0 descendants of its own
- K251613: SwissGraft X (2025), 0 descendants of its own

## Indications for use
Geistlich Bio-Oss® is intended for the following uses: * 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); and * Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Source page: https://510kreport.com/device/K240661
Methodology: https://510kreport.com/methodology