510(k) · Cleared
ClearedCleared Under Grafton II Edbm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Cleared on Mar 6, 2013 as substantially equivalent to K082615 (Osteotech, Inc., 2008) after a 201-day review. Its family tree reaches back 1 generation to 2008. 4 later devices descend from it.
- Decided
- Mar 6, 2013
- Review
- 201 days
- Class
- Class II
- Product code
- MBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082615 (2008). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK082615 Grafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable…Osteotech, Inc. · 2008 · Recalled
- This deviceK122513 Cleared Under Grafton II EdbmMedtronic Sofamor Danek, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK172130 Resorbable Mesh DeviceSeaSpine Orthopedics Corporation · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK200290 Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)SeaSpine Orthopedics Corporation · 2020
- Descendant · 2 generations on · 0 of its ownK193040 Resorbable Mesh DeviceSeaSpine Orthopedics Corporation · 2019
- Descendant · cites it directly · 0 of its ownK131673 Magnifuse Bone Graft, Magifuse II Bone GraftMedtronic Sofamor Danek USA, Inc. · 2013
Most influential descendants
Showing 4 of 4 · See all- K172130Resorbable Mesh DeviceSeaSpine Orthopedics Corporation · 2017 · cites it directly2descendants
- K200290Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)SeaSpine Orthopedics Corporation · 2020 · 2 generations on0descendants
- K193040Resorbable Mesh DeviceSeaSpine Orthopedics Corporation · 2019 · 2 generations on0descendants
- K131673Magnifuse Bone Graft, Magifuse II Bone GraftMedtronic Sofamor Danek USA, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082615 | Grafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium… | Osteotech, Inc. | 2008 | 1 |
| 0 (this device) | K122513 | Cleared Under Grafton II Edbm | Medtronic Sofamor Danek, Inc. | 2013 | — |
| +1 | K172130 | Resorbable Mesh Device | SeaSpine Orthopedics Corporation | 2017 | 1 |
| +2 | K200290 | Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) | SeaSpine Orthopedics Corporation | 2020 | — |
| +2 | K193040 | Resorbable Mesh Device | SeaSpine Orthopedics Corporation | 2019 | — |
| +1 | K131673 | Magnifuse Bone Graft, Magifuse II Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MBP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MBP device
- #1 K242799 PliaFX Floscore 9.0 · 3 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082615 | Grafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium Salt Bone…Summary page 1…11 PRODUCT CODE: - MQV, MBP Ill. IDENTIFICATION OF LEGALLY MARKETED DEVICES: Grafton(@ 11eDBM (K082615, SE 10/16/2008) IV. DEVICE DESCRIPTION: MAGNIFUSE® 11Bone Graft is assenmbled by the clinician at the time of the… | 2008 |
| † | K051195 | Grafton DBM | 2005 |
| † | K061982 | Plexur P | 2007 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MBP devicesMBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MBP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MBP
181in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBP
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBP
2in 2025
MAUDE reports naming product code MBP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 188 | 0 | 7 |
| 2008 | 5 | 93 | 0 | 15 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 1 | — | 2 | 18 |
| 2012 | 1 | — | 13 | 24 |
| 2013 | 3 | 181 | 0 | 16 |
| 2014 | 0 | — | 1 | 15 |
| 2015 | 1 | — | 0 | 11 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 7 | 6 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122513: Cleared Under Grafton II Edbm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122513
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026