510(k) · Cleared
ClearedMastergraft Putty, Mastergraft Strip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Apr 18, 2014 as substantially equivalent to K082166 (Medtronic Sofamor Danek, 2009) and 1 other predicate after a 63-day review. Its family tree reaches back 8 generations to 1996. 30 later devices descend from it.
- Decided
- Apr 18, 2014
- Review
- 63 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K960978 (1996). 33 ancestors in all, the oldest K871773 (1987). 30 later devices descend from it, 17 citing it directly.
- Root · 8 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 7 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 6 generations backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
- 5 generations backK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
- 4 generations backK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005
- 3 generations backK051386 Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005
- 2 generations backK071813 Mastergraft PuttyMedtronic Sofamor Danek · 2007
- 1 generation backK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
- This deviceK140375 Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014
- Descendant · cites it directly · 6 of its ownK181225 AltaporeBaxter Healthcare Corporation · 2018
- Descendant · cites it directly · 4 of its ownK193075 Osteo3 ZP PuttySirakoss, Ltd. · 2020
- Descendant · cites it directly · 4 of its ownK192363 AltaporeBaxter Healthcare Corporation · 2020
- Descendant · 2 generations on · 3 of its ownK211201 MagnetOs Easypack PuttyKuros Biosciences B.V · 2021
- Descendant · cites it directly · 3 of its ownK182074 Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc. · 2019
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K181225AltaporeBaxter Healthcare Corporation · 2018 · cites it directly6descendants
- K193075Osteo3 ZP PuttySirakoss, Ltd. · 2020 · cites it directly4descendants
- K192363AltaporeBaxter Healthcare Corporation · 2020 · cites it directly4descendants
- K211201MagnetOs Easypack PuttyKuros Biosciences B.V · 2021 · 2 generations on3descendants
- K182074Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc. · 2019 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −7 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −6 | K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101… | Interpore Cross Intl. | 2000 | — |
| −5 | K012751 | Healos Bone Graft Material | Orquest, Inc. | 2001 | — |
| −4 | K043308 | Modification to: Healos Bone Graft Material | Depuy Spine, Inc. | 2005 | — |
| −3 | K051386 | Mastergraft Putty Bone Void Filler | Medtronic Vascular | 2005 | — |
| −2 | K071813 | Mastergraft Putty | Medtronic Sofamor Danek | 2007 | — |
| −1 | K082166 | Mastergraft Strip | Medtronic Sofamor Danek | 2009 | — |
| 0 (this device) | K140375 | Mastergraft Putty, Mastergraft Strip | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| +1 | K181225 | Altapore | Baxter Healthcare Corporation | 2018 | — |
| +1 | K193075 | Osteo3 ZP Putty | Sirakoss, Ltd. | 2020 | — |
| +1 | K192363 | Altapore | Baxter Healthcare Corporation | 2020 | — |
| +2 | K211201 | MagnetOs Easypack Putty | Kuros Biosciences B.V | 2021 | — |
| +1 | K182074 | Mineral Collagen Composite Bioactive Moldable | Collagen Matrix, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K082166 | Mastergraft StripSummary page 1…Device name 510Q4ua nmber, Substantial Equivalence date MASTERGRAFT®9 Strip K082 166 06/02/2009 MASTERORAFT®) Putty K071813 11/09/2007… | 2009 |
| * | K071813 | Mastergraft PuttySummary page 1…nmber, Substantial Equivalence date MASTERGRAFT®9 Strip K082 166 06/02/2009 MASTERORAFT®) Putty K071813 11/09/2007 K140375 - Page 2 of 6… | 2007 |
| † | K023553 | Mastergraft Matrix | 2003 |
| † | K012751 | Healos Bone Graft Material | 2001 |
What descends from it? (30)
See all 3017 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181225 | Altapore | 2018 | 6 |
| K193075 | Osteo3 ZP Putty | 2020 | 4 |
| K192363 | Altapore | 2020 | 4 |
| K182074 | Mineral Collagen Composite Bioactive Moldable | 2019 | 3 |
| K191513 | Altapore Shape | 2019 | 2 |
| K242797 | OsteoFlo HydroFiber | 2024 | 1 |
| K230486 | Cove Strip | 2023 | 1 |
| K212991 | Osteorevive | 2022 | 1 |
| K200640 | Altapore Shape | 2020 | 1 |
| K172573 | ReBOSSIS85 | 2017 | 1 |
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 18 years and passes through 8 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 33 ancestors have a recall of any class.
- Of its descendants, K181225 (Baxter Healthcare Corporation, 2018) has gone furthest, with 6 descendants of its own.
- 6 other devices also cite its predicate K082166.
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. 2014, 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® Strip is to be combined with autogenous bone marrow and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure and can be used as a bone graft extender. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e.. the posterolateral spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic…
Read the full statement (195 words)
MASTERGRAFT® Strip is to be combined with autogenous bone marrow and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure and can be used as a bone graft extender.
The device is to be gently packed into bony voids or gaps of the skeletal system (i.e.. 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. The device resorbs and is replaced with bone during the healing process.
MASTERGRAFT® Putty combined with either autogenous bone marrow, and/or sterile water. and/or autograft is indicated as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. Additionally. MASTERGRAFT® Putty can be used with autograft as a bone graft extender. MASTERGRAFT® Putty 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® Putty resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140375 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140375: Mastergraft Putty, Mastergraft Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140375
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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