# K251193: Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Jun 12, 2025 after 56 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) Prosidyan - Fibergraft® BG Putty: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K090317: Babi*Plus Bubble Pap Valve, A Plus Medical (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
Grafton™ DBM and Grafton Plus ™ DBM Paste are intended for use as a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space (excluding Flex or Crunch), pelvis and extremities) 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. When used in intervertebral body fusion procedures, Graft™ DBM (excluding Flex or Crunch) and Grafton Plus ™ DBM Paste must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. Grafton™ DBM and Grafton Plus™ DBM Paste are absorbed/remodeled and replaced by host bone during the healing process. Magnifuse™ Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, pelvis and extremities) not intrinsic to the stability of the bony structure. Voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. Magnifuse™ Bone Graft may be used in a manner comparable to autogenous bone or allograft bone. Magnifuse™ Bone Graft may be mixed with fluid such as bone marrow aspirate, blood, sterile water, or sterile water in order to adjust consistency and handling of bone graft material. When used in intervertebral body fusion procedures, Magnifuse ™ Bone Graft must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. Magnifuse™ Bone Graft is resorbed/remodeled and is replaced by host bone during the healing process.

Source page: https://510kreport.com/device/K251193
Methodology: https://510kreport.com/methodology