# K040646: Straumann Granules

- Pathway: 510(k) (Traditional)
- Applicant: The Straumann Co.
- Decided: May 3, 2004 after 53 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- 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: 3 generations back to K960978 (1996). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990131: Pro Osteon Implant 500R Resorbable Bone Graft Substitute, Interpore Cross Intl. (1999) Summary page 1.
- K010701: Medtronic Sofamor Danek Biphasic Calcium Phosphate (BCP) Bone Void Filler, Medtronic Sofamor Danek USA, Inc. (2001) Summary page 1.
- K970321: Bio-Oss Anorganic Bovine Bone, Geistlich-Pharma (1998) Summary page 1.
- K960164: Bio-Interfaces, Inc., Bioresorbable Calcium Phosphate Particles - Bii-Graft 6140, Bio-Interfaces, Inc. (1996) Summary page 1.
- K032268: MBCP, Biomatlante (2003) Summary page 1.
- K030131: Ossatura BCP Bone Void Filler, Isotis NV (2003) Summary page 1.

## Most influential descendants
- K201051: Straumann BoneCeramic (2020), 0 descendants of its own
- K050170: Fortoss Vital Bone Graft Substitute (2005), 0 descendants of its own

## Indications for use
Straumann Granules are indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.

Source page: https://510kreport.com/device/K040646
Methodology: https://510kreport.com/methodology