# K020986: Mastergraft Resorbable Ceramic

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Jul 22, 2002 after 117 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: 1 generation back to K990131 (1999). 1 ancestor in all.
158 later devices descend from it; 9 cite it directly.
0 of 160 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990131: Pro Osteon Implant 500R Resorbable Bone Graft Substitute, Interpore Cross Intl. (1999) Summary page 1.

## Most influential descendants
- K032268: MBCP (2003), 142 descendants of its own
- K043005: Modification to MBCP (2005), 122 descendants of its own
- K051774: MBCP (2006), 60 descendants of its own
- K051386: Mastergraft Putty Bone Void Filler (2005), 59 descendants of its own
- K051885: MBCP (2005), 59 descendants of its own

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

Source page: https://510kreport.com/device/K020986
Methodology: https://510kreport.com/methodology