# K952617: Bio-Oss

- Pathway: 510(k) (Traditional)
- Applicant: Geistlich-Pharma
- Decided: Aug 7, 1995 after 62 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
No predicates in its family tree.
125 later devices descend from it; 6 cite it directly.
0 of 126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K033815: Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen (2004), 124 descendants of its own
- 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

Source page: https://510kreport.com/device/K952617
Methodology: https://510kreport.com/methodology