510(k) · Cleared
ClearedMastergraft Resorbable Ceramic Granules
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · MQV Filler, Bone Void, Calcium Compound
Cleared on Feb 9, 2009 as substantially equivalent to K020986 (Medtronic Sofamor Danek, Inc., 2002) and 1 other predicate after a 132-day review. Its family tree reaches back 5 generations to 1999. 1 later device descends from it.
- Decided
- Feb 9, 2009
- Review
- 132 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K990131 (1999). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 4 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
- 3 generations backK032268 MBCPBiomatlante · 2003
- 2 generations backK043005 Modification to MBCPBiomatlante · 2005
- 1 generation backK051774 MBCPBiomatlante · 2006
- This deviceK082918 Mastergraft Resorbable Ceramic GranulesMedtronic Sofamor Danek · 2009
- Descendant · cites it directly · 0 of its ownK100986 Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler…Skeletal Kinetics, LLC · 2010 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K100986Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo VationSkeletal Kinetics, LLC · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −4 | K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −3 | K032268 | MBCP | Biomatlante | 2003 | — |
| −2 | K043005 | Modification to MBCP | Biomatlante | 2005 | — |
| −1 | K051774 | MBCP | Biomatlante | 2006 | — |
| 0 (this device) | K082918 | Mastergraft Resorbable Ceramic Granules | Medtronic Sofamor Danek | 2009 | — |
| +1 | K100986 | Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo Vation | Skeletal Kinetics, LLC | 2010 | 11 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K020986 | Mastergraft Resorbable CeramicSummary page 1…raft extender, as well as expand the size range to include smaller sizes. Like the previously cleared predicates, MASTERGRAFT® Resorbable Ceramic Granules (K020986, SE 0712212002) and MBCP TM (KO51774, SE 01/2012006), the subject system is intended as a bone void filler for bony… | 2002 |
| * | K051774 | MBCPSummary page 2…Ceramic Granules to be substantially equivalent to the previously cleared MASTERGRAFT® Resorbable Ceramic Granules (K020986, SE 07/22/2002) and MBCP T M (K051774, SE 01/20/2006). MASTERGRAFT Granules DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100986 | Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo Vation | 2010 | 0 |
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?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K100986 (Skeletal Kinetics, LLC, 2010) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K020986.
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. 2009, 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?
MASTERGRAFT® Resorbable Ceramic Granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Additionally, MASTERGRAFT® Resorbable Ceramic Granules can- be Used with autograft as a bone graft extender. MASTERGRAFT®·Resorbable Ceramic Granules is to be gently packed into bony voids or gaps of the skeletal system· ·(e.g., the posterolateral spine, pelvis, ilium and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MASTERGRAFT® provides a bone void filler that resorbs and is replaced with bone during the .healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082918 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082918: Mastergraft Resorbable Ceramic Granules.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082918
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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