# K130335: Mastergraft Strip; Mastergraft Ultramatrix

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Apr 19, 2013 after 67 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: 8 generations back to K960978 (1996). 33 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 36 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 1.

## Most influential descendants
- K151172: MASTERGRAFT Contain (2015), 0 descendants of its own
- K141824: Mastergraft Matrix Ext; Mastergraft Putty, Mastergraft Strip (2014), 0 descendants of its own

## Indications for use
MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix are to be combined with autogenous bone marrow and are 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.

Source page: https://510kreport.com/device/K130335
Methodology: https://510kreport.com/methodology