# K051386: Mastergraft Putty Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Dec 16, 2005 after 203 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 K960978 (1996). 14 ancestors in all.
59 later devices descend from it; 5 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020986: Mastergraft Resorbable Ceramic, Medtronic Sofamor Danek, Inc. (2002) Summary page 2.
- K012506: Mastergraft Resorbable Ceramic Granules, Medtronic Sofamor Danek USA, Inc. (2002) Summary page 2.
- K032288: Vitoss Scaffold Foam Bone Graft Material, Orthovita, Inc. (2003) Summary page 2.
- K043308: Modification to: Healos Bone Graft Material, Depuy Spine, Inc. (2005) Summary page 2.
- K012751: Healos Bone Graft Material, Orquest, Inc. (2001) Summary page 2.

## Most influential descendants
- K071813: Mastergraft Putty (2007), 47 descendants of its own
- K082166: Mastergraft Strip (2009), 38 descendants of its own
- K140375: Mastergraft Putty, Mastergraft Strip (2014), 30 descendants of its own
- K060917: Kensey Nash Bone Void Filler (2006), 7 descendants of its own
- K181225: Altapore (2018), 6 descendants of its own

## Indications for use
MasterGraft® Putty combined with either autogenous bone marrow, and/or sterile water, and/or autograft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft® Matrix 1s to be combined with autogenous bone¢ marrow and like MasterGraft® Puity is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Both devices are to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, pelvis, ileum, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Both devices provide a bone void filler that resorbs and ts replaced with bone during the healing process.

Source page: https://510kreport.com/device/K051386
Methodology: https://510kreport.com/methodology