# K113246: OCS-B

- Pathway: 510(k) (Traditional)
- Applicant: Nibec Company, Limited
- Decided: Jan 16, 2013 after 441 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.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871773: Bio-Oss Pure Nat Hydroxyapatite Endoss Implant, Geistlich-Pharma (1987) Summary page 1.
- K952617: Bio-Oss, Geistlich-Pharma (1995) Summary page 1.
- K970321: Bio-Oss Anorganic Bovine Bone, Geistlich-Pharma (1998) Summary page 1.
- K033815: Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen, Geistlich-Pharma (2004) Summary page 1.

## Most influential descendants
- K140021: TI-OSS (2015), 0 descendants of its own

## Indications for use
OCS-Bw'cancellous and cortical granules are recommended for: - Augmentation or reconstructive treatment of the alveolar ridge. - Filling of infrabony periodontal defects. - Filling of detects after maot resection, apicoectomy, and cystectomy - 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 pert-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

Source page: https://510kreport.com/device/K113246
Methodology: https://510kreport.com/methodology