510(k) · Cleared
ClearedMastergraft Putty Bone Void Filler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · MQV Filler, Bone Void, Calcium Compound
Cleared on Dec 16, 2005 as substantially equivalent to K020986 (Medtronic Sofamor Danek, Inc., 2002) and 4 other predicates after a 203-day review. Its family tree reaches back 5 generations to 1996. 59 later devices descend from it.
- Decided
- Dec 16, 2005
- Review
- 203 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K960978 (1996). 14 ancestors in all. 59 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 4 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 3 generations backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
- 2 generations backK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
- 1 generation backK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005
- This deviceK051386 Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005
- Descendant · cites it directly · 47 of its ownK071813 Mastergraft PuttyMedtronic Sofamor Danek · 2007
- Descendant · 2 generations on · 38 of its ownK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
- Descendant · 2 generations on · 30 of its ownK140375 Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014
- Descendant · cites it directly · 7 of its ownK060917 Kensey Nash Bone Void FillerKensey Nash Corporation · 2006
- Descendant · 3 generations on · 6 of its ownK181225 AltaporeBaxter Healthcare Corporation · 2018
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K071813Mastergraft PuttyMedtronic Sofamor Danek · 2007 · cites it directly47descendants
- K082166Mastergraft StripMedtronic Sofamor Danek · 2009 · 2 generations on38descendants
- K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014 · 2 generations on30descendants
- K060917Kensey Nash Bone Void FillerKensey Nash Corporation · 2006 · cites it directly7descendants
- K181225AltaporeBaxter Healthcare Corporation · 2018 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −4 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −3 | K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101… | Interpore Cross Intl. | 2000 | — |
| −2 | K012751 | Healos Bone Graft Material | Orquest, Inc. | 2001 | — |
| −1 | K043308 | Modification to: Healos Bone Graft Material | Depuy Spine, Inc. | 2005 | — |
| 0 (this device) | K051386 | Mastergraft Putty Bone Void Filler | Medtronic Vascular | 2005 | — |
| +1 | K071813 | Mastergraft Putty | Medtronic Sofamor Danek | 2007 | — |
| +2 | K082166 | Mastergraft Strip | Medtronic Sofamor Danek | 2009 | — |
| +2 | K140375 | Mastergraft Putty, Mastergraft Strip | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| +1 | K060917 | Kensey Nash Bone Void Filler | Kensey Nash Corporation | 2006 | — |
| +3 | K181225 | Altapore | Baxter Healthcare Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 8 | 0 |
| 2024 | 8 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (5)
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 2…valence Documentation was provided which demonstrated MasterGrafi®Putty to be substantially cquivalent to the previously cleared MasterGraft® Matrix Resorbable Ceramic (K020986 and K012506). and to Orthovita’s Vitoss Scaffold Foam Flow Bone Grafi Matcrial (K032288) and DePuy’s HEALOS® Bone Graft Material… | 2002 |
| * | K012506 | Mastergraft Resorbable Ceramic GranulesSummary page 2…umentation was provided which demonstrated MasterGrafi®Putty to be substantially cquivalent to the previously cleared MasterGraft® Matrix Resorbable Ceramic (K020986 and K012506). and to Orthovita’s Vitoss Scaffold Foam Flow Bone Grafi Matcrial (K032288) and DePuy’s HEALOS® Bone Graft Material (K043308 and… | 2002 |
| * | K032288 | Vitoss Scaffold Foam Bone Graft MaterialSummary page 2…ally cquivalent to the previously cleared MasterGraft® Matrix Resorbable Ceramic (K020986 and K012506). and to Orthovita’s Vitoss Scaffold Foam Flow Bone Grafi Matcrial (K032288) and DePuy’s HEALOS® Bone Graft Material (K043308 and K012751 ). 0000046 % “, LT Public Health Service Food an… | 2003 |
| * | K043308 | Modification to: Healos Bone Graft MaterialSummary page 2…aft® Matrix Resorbable Ceramic (K020986 and K012506). and to Orthovita’s Vitoss Scaffold Foam Flow Bone Grafi Matcrial (K032288) and DePuy’s HEALOS® Bone Graft Material (K043308 and K012751 ). 0000046 % “, LT Public Health Service Food and Drug Administration 9200 Corporate Boulevard Roc… | 2005 |
| * | K012751 | Healos Bone Graft MaterialSummary page 2…Resorbable Ceramic (K020986 and K012506). and to Orthovita’s Vitoss Scaffold Foam Flow Bone Grafi Matcrial (K032288) and DePuy’s HEALOS® Bone Graft Material (K043308 and K012751 ). 0000046 % “, LT Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20… | 2001 |
What descends from it? (59)
See all 595 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?
- The line of descent spans 9 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K071813 (Medtronic Sofamor Danek, 2007) has gone furthest, with 47 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.
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® Putty combined with either autogenous bone marrow, and/or sterile water, and/or autograft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft® Matrix 1s to be combined with autogenous bone¢ marrow and like MasterGraft® Puity is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Both devices are to be gently packed into bony voids…
Read the full statement (125 words)
MasterGraft® Putty combined with either autogenous bone marrow, and/or sterile water, and/or autograft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft® Matrix 1s to be combined with autogenous bone¢ marrow and like MasterGraft® Puity is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Both devices are to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, pelvis, ileum, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Both devices provide a bone void filler that resorbs and ts replaced with bone during the healing process.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K051386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051386: Mastergraft Putty Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051386
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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