510(k) · Cleared
Recalled · Class II · 2023Grafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium Salt Bone Void Filler Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteotech, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Oct 16, 2008 after a 37-day review. The FDA summary names no predicate by number. 7 later devices descend from it. It has been recalled once.
- Decided
- Oct 16, 2008
- Review
- 37 days
- Class
- Class II
- Product code
- MQV
- Recalls
- 1
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK082615 Grafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable…Osteotech, Inc. · 2008
- Descendant · cites it directly · 5 of its ownK123691 Magnifuse Bone Graft (Cleared as Grafton II Edbm)Medtronic Sofamor Danek, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK122513 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 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
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K123691Magnifuse Bone Graft (Cleared as Grafton II Edbm)Medtronic Sofamor Danek, Inc. · 2013 · cites it directly5descendants
- K122513Cleared Under Grafton II EdbmMedtronic Sofamor Danek, Inc. · 2013 · cites it directly4descendants
- K172130Resorbable Mesh DeviceSeaSpine Orthopedics Corporation · 2017 · cites it directly2descendants
- K203218CaP Spheres Pellet PackZimmer Biomet Spine, Inc. · 2021 · 2 generations on0descendants
- K200290Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)SeaSpine Orthopedics Corporation · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082615 | Grafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium… | Osteotech, Inc. | 2008 | — |
| +1 | K123691 | Magnifuse Bone Graft (Cleared as Grafton II Edbm) | Medtronic Sofamor Danek, Inc. | 2013 | — |
| +1 | K122513 | Cleared Under Grafton II Edbm | Medtronic Sofamor Danek, Inc. | 2013 | — |
| +1 | K172130 | Resorbable Mesh Device | SeaSpine Orthopedics Corporation | 2017 | 1 |
| +2 | K203218 | CaP Spheres Pellet Pack | Zimmer Biomet Spine, Inc. | 2021 | — |
| +2 | K200290 | Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) | SeaSpine Orthopedics Corporation | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 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?
The FDA summary names no predicate by number.
What descends from it? (7)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 31, 2023 | Class II | Z-2524-2023 | Process control | The incorrect product labeling was applied to the product indicating the wrong size of product. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K123691 (Medtronic Sofamor Danek, Inc., 2013) has gone furthest, with 5 descendants of its own.
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. 2008, 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?
GRAFTON®II 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., spine, 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. GRAFTON®II eDBM is resorbed/remodeled and is replaced by host bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082615: Grafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium Salt Bone Void Filler Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082615
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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