# K082918: Mastergraft Resorbable Ceramic Granules

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Feb 9, 2009 after 132 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.
1 later device descends from it; 1 cites it directly.
0 of 8 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 1.
- K051774: MBCP, Biomatlante (2006) Summary page 2.

## Most influential descendants
- K100986: Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo Vation (2010), 0 descendants of its own

## Indications for use
MASTERGRAFT® Resorbable Ceramic Granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Additionally, MASTERGRAFT® Resorbable Ceramic Granules can- be Used with autograft as a bone graft extender. MASTERGRAFT®·Resorbable Ceramic Granules is to be gently packed into bony voids or gaps of the skeletal system· ·(e.g., the posterolateral spine, pelvis, ilium 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/K082918
Methodology: https://510kreport.com/methodology