# K033815: Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen

- Pathway: 510(k) (Traditional)
- Applicant: Geistlich-Pharma
- Decided: Jan 15, 2004 after 37 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: 1 generation back to K871773 (1987). 7 ancestors in all.
124 later devices descend from it; 18 cite it directly.
0 of 132 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.
- K920508: Bio-Oss Blocks, Geistlich-Pharma (1992) Summary page 1.
- K952618: Bio-Oss, Geistlich-Pharma (1995) Summary page 1.
- K970569: Bio-Blocks, Geistlich-Pharma (2000) Summary page 1.
- K974399: Bio-Oss Collagen, Geistlich-Pharma (1998) Summary page 1.

## Most influential descendants
- K043034: Osteoguide Anorganic Bone Mineral Products (2005), 55 descendants of its own
- K052812: Ossimend (TM) Bone Graft Material (2006), 40 descendants of its own
- K082166: Mastergraft Strip (2009), 38 descendants of its own
- K140375: Mastergraft Putty, Mastergraft Strip (2014), 30 descendants of its own
- K092428: Bio-Oss Collagen (2010), 29 descendants of its own

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

Source page: https://510kreport.com/device/K033815
Methodology: https://510kreport.com/methodology