510(k) · Cleared
ClearedMagnifuse Bone Graft (Cleared as Grafton II Edbm)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Jan 31, 2013 as substantially equivalent to K082615 (Osteotech, Inc., 2008) and 1 other predicate after a 59-day review. Its family tree reaches back 1 generation to 2005. 5 later devices descend from it.
- Decided
- Jan 31, 2013
- Review
- 59 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K051195 (2005). 2 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK051195 Grafton DBMOsteotech, Inc. · 2005 · Recalled
- This deviceK123691 Magnifuse Bone Graft (Cleared as Grafton II Edbm)Medtronic Sofamor Danek, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK172130 Resorbable Mesh DeviceSeaSpine Orthopedics Corporation · 2017 · Recalled
- Descendant · cites it directly · 0 of its ownK203218 CaP Spheres Pellet PackZimmer Biomet Spine, Inc. · 2021
- 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 5 of 5 · See all- K172130Resorbable Mesh DeviceSeaSpine Orthopedics Corporation · 2017 · cites it directly2descendants
- K203218CaP Spheres Pellet PackZimmer Biomet Spine, Inc. · 2021 · cites it directly0descendants
- 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 | K051195 | Grafton DBM | Osteotech, Inc. | 2005 | 30 |
| 0 (this device) | K123691 | Magnifuse Bone Graft (Cleared as Grafton II Edbm) | Medtronic Sofamor Danek, Inc. | 2013 | — |
| +1 | K172130 | Resorbable Mesh Device | SeaSpine Orthopedics Corporation | 2017 | 1 |
| +1 | K203218 | CaP Spheres Pellet Pack | Zimmer Biomet Spine, Inc. | 2021 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 MQV? 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 MQV device
- #1 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 2…rocess. VI. Identification of the Legally Marketed Predicate Devices Use to Claim Substantial Equivalence: Predicate Devices: MAGNIFUSE Bone Graft [K082615, SE 10/16/20081; (Cleared as Grafton 11 eDBM) GRAFTON DBM [K(051195, SE 1… | 2008 |
| * | K051195 | Grafton DBMSummary page 2…Predicate Devices: MAGNIFUSE Bone Graft [K082615, SE 10/16/20081; (Cleared as Grafton 11 eDBM) GRAFTON DBM [K(051195, SE 12/16/2005] Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler de… | 2005 |
What descends from it? (5)
3 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 MQV devicesMQV Filler, Bone Void, Calcium Compound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MQV
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQV
57in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQV
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQV
57in 2025
MAUDE reports naming product code MQV, 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 | 35 | 144 | 5 | 67 |
| 2008 | 32 | 102 | 3 | 71 |
| 2009 | 23 | 180 | 1 | 81 |
| 2010 | 17 | 147 | 0 | 68 |
| 2011 | 16 | 92 | 6 | 114 |
| 2012 | 9 | 107 | 3 | 149 |
| 2013 | 12 | 197 | 2 | 223 |
| 2014 | 20 | 153 | 0 | 111 |
| 2015 | 18 | 184 | 0 | 125 |
| 2016 | 8 | 214 | 1 | 106 |
| 2017 | 17 | 124 | 1 | 107 |
| 2018 | 23 | 124 | 2 | 86 |
| 2019 | 13 | 90 | 0 | 65 |
| 2020 | 15 | 132 | 1 | 126 |
| 2021 | 8 | 88 | 0 | 101 |
| 2022 | 9 | 118 | 0 | 47 |
| 2023 | 21 | 74 | 3 | 120 |
| 2024 | 28 | 55 | 2 | 68 |
| 2025 | 14 | 57 | 1 | 57 |
| 2026 | 5 | 96 | 4 | — |
What is it indicated for?
MAGNIFUSE® Bone Graft (GRAFTON® 11 eDBM) is intended for use as a bone graft substitute and bone void filler 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® 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/K123691 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123691: Magnifuse Bone Graft (Cleared as 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/K123691
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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