# K131673: Magnifuse Bone Graft, Magifuse II Bone Graft

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Oct 3, 2013 after 118 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: 2 generations back to K051195 (2005). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123691: Magnifuse Bone Graft (Cleared as Grafton II Edbm), Medtronic Sofamor Danek, Inc. (2013) Summary page 1.
- K122513: Cleared Under Grafton II Edbm, Medtronic Sofamor Danek, Inc. (2013) Summary page 1.

## Indications for use
MAGNIFUSE® 11 Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. MAGNIFUSE® 11 Bone Graft is resorbed/remodeled and replaced by host bone during the healing process.

Source page: https://510kreport.com/device/K131673
Methodology: https://510kreport.com/methodology