# K012506: Mastergraft Resorbable Ceramic Granules

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Mar 7, 2002 after 213 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
No predicates in its family tree.
61 later devices descend from it; 4 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K051386: Mastergraft Putty Bone Void Filler (2005), 59 descendants of its own
- K071813: Mastergraft Putty (2007), 47 descendants of its own
- K023553: Mastergraft Matrix (2003), 39 descendants of its own
- K082166: Mastergraft Strip (2009), 38 descendants of its own
- K140375: Mastergraft Putty, Mastergraft Strip (2014), 30 descendants of its own

## Indications for use
MasterGraft™ Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft™ Bone Void Filler is to be gently packed into bony voids of the skeletal system (e.g., the spine, pelvis, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MasterGraft™ provides a bone void filler that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K012506
Methodology: https://510kreport.com/methodology