# K122513: Cleared Under Grafton II Edbm

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Mar 6, 2013 after 201 days
- Product code: MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor))
- 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 K082615 (2008). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082615: Grafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium Salt Bone Void Filler Devices, Osteotech, Inc. (2008) Summary page 1.

## Most influential descendants
- K172130: Resorbable Mesh Device (2017), 2 descendants of its own
- K200290: Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) (2020), 0 descendants of its own
- K193040: Resorbable Mesh Device (2019), 0 descendants of its own
- K131673: Magnifuse Bone Graft, Magifuse II Bone Graft (2013), 0 descendants of its own

## Indications for use
MAGNIFUSE® II 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® II Bone Graft is resorbed/remodeled and replaced by host bone during the healing process.

Source page: https://510kreport.com/device/K122513
Methodology: https://510kreport.com/methodology