# K120601: Geistlich Bio-Oss Pen (0.25 G, 0.25-1.0MM Granules), Geistlich Bio-Oss Pen (0.5 G, 0.25-1.0MM Granules), Geistlich Bio-O

- Pathway: 510(k) (Traditional)
- Applicant: Geistlich Pharma AG
- Decided: May 24, 2012 after 86 days
- Product code: NPM (Bone Grafting Material, Animal Source)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K924408 (1995). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112572: Geistlich Combi-Kit Collegen, Geistlich Pharma AG (2011) Summary page 1.
- K033815: Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen, Geistlich-Pharma (2004) Summary page 1.

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

## Recalls of this device
- Oct 19, 2020 · Class II · Z-0490-2021: Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly in use for the sinus 
- Oct 19, 2020 · Class II · Z-0491-2021: Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly in use for the sinus 
- Oct 19, 2020 · Class II · Z-0492-2021: Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly in use for the sinus 
- Apr 12, 2019 · Class II · Z-2146-2019: When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
- Apr 12, 2019 · Class II · Z-2145-2019: When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
- Apr 12, 2019 · Class II · Z-2147-2019: When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.

## 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 pen-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Source page: https://510kreport.com/device/K120601
Methodology: https://510kreport.com/methodology