# K010701: Medtronic Sofamor Danek Biphasic Calcium Phosphate (BCP) Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Jun 5, 2001 after 89 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K040646: Straumann Granules (2004), 2 descendants of its own
- K081784: Mastergraft Putty (2008), 1 descendant of its own
- K201051: Straumann BoneCeramic (2020), 0 descendants of its own
- K140374: Mastergraft Putty (2014), 0 descendants of its own
- K050170: Fortoss Vital Bone Graft Substitute (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K010701
Methodology: https://510kreport.com/methodology