# K151172: MASTERGRAFT Contain

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Aug 14, 2015 after 105 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: 9 generations back to K960978 (1996). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082166: Mastergraft Strip, Medtronic Sofamor Danek (2009) Summary page 4.
- K130335: Mastergraft Strip; Mastergraft Ultramatrix, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 4.

## Indications for use
MASTERGRAFT® Contain is to be combined with autogenous bone marrow and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure and can be used as a bone graft extender. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., 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. The device resorbs and is replaced with bone during the healing process. When used in the pelvis, ilium, or extremities, the device is to be used with bone marrow aspirate. When used in the posterolateral spine, the device must be mixed with bone marrow aspirate and autograft bone and used as a bone graft extender.

Source page: https://510kreport.com/device/K151172
Methodology: https://510kreport.com/methodology