# K073064: Graftys BCP

- Pathway: 510(k) (Abbreviated)
- Applicant: Graftys
- Decided: Mar 11, 2008 after 133 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K990131 (1999). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051774: MBCP, Biomatlante (2006) Summary page 1.
- K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita Co. (2000) Summary page 1.

## Most influential descendants
- K082286: Bioactys (2009), 1 descendant of its own
- K103820: Reprobone Dental Grafting Material (2011), 0 descendants of its own

## Indications for use
GRAFTYS®BCP is intended for use as a bone void filler for voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure. GRAFTYS BCP has limited initial mechanical properties. Therefore rigid fixation techniques may often be recommended. GRAFTYS®BCP can be used with autograft as a bone graft extender. In addition when used with appropriate opening osteotomy system devices, plates and screws, GRAFTYS®BCP is intended to be used as a bone void filler in femoral or tibial osteotomies

Source page: https://510kreport.com/device/K073064
Methodology: https://510kreport.com/methodology