510(k) · Cleared
ClearedSynthetic Bone Putty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ventris Medical · MQV Filler, Bone Void, Calcium Compound
Cleared on Sep 2, 2022 as substantially equivalent to K140375 (Medtronic Sofamor Danek USA, Inc., 2014) and 1 other predicate after an 88-day review. Its family tree reaches back 9 generations to 1996.
- Decided
- Sep 2, 2022
- Review
- 88 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K960978 (1996). 44 ancestors in all, the oldest K871773 (1987). No later device cites it as a predicate yet.
- Root · 9 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 5 generations between
- 3 generations backK071813 Mastergraft PuttyMedtronic Sofamor Danek · 2007
- 2 generations backK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
- 1 generation backK140375 Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014
- This deviceK221644 Synthetic Bone PuttyVentris Medical · 2022
Show all 9 generations
- Root · 9 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 8 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 7 generations backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
- 6 generations backK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
- 5 generations backK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005
- 4 generations backK051386 Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005
- 3 generations backK071813 Mastergraft PuttyMedtronic Sofamor Danek · 2007
- 2 generations backK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
- 1 generation backK140375 Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014
- This deviceK221644 Synthetic Bone PuttyVentris Medical · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −8 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −7 | K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101… | Interpore Cross Intl. | 2000 | — |
| −6 | K012751 | Healos Bone Graft Material | Orquest, Inc. | 2001 | — |
| −5 | K043308 | Modification to: Healos Bone Graft Material | Depuy Spine, Inc. | 2005 | — |
| −4 | K051386 | Mastergraft Putty Bone Void Filler | Medtronic Vascular | 2005 | — |
| −3 | K071813 | Mastergraft Putty | Medtronic Sofamor Danek | 2007 | — |
| −2 | K082166 | Mastergraft Strip | Medtronic Sofamor Danek | 2009 | — |
| −1 | K140375 | Mastergraft Putty, Mastergraft Strip | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| 0 (this device) | K221644 | Synthetic Bone Putty | Ventris Medical | 2022 | — |
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 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K140375 | Mastergraft Putty, Mastergraft StripSummary page 4…bstitute Classification: Class 2 Regulation: 888.3045, Resorbable calcium salt bone void filler device Product Code: MQV Predicate Device(s): K140375: Mastergraft Putty (Medtronic Sofamor Danek USA, Inc.) K132071: Bioactive Bone Graft Putty (BioStructures, LLC) Indications For… | 2014 |
| * | K132071 | Bioactive Bone Graft PuttySummary page 4…888.3045, Resorbable calcium salt bone void filler device Product Code: MQV Predicate Device(s): K140375: Mastergraft Putty (Medtronic Sofamor Danek USA, Inc.) K132071: Bioactive Bone Graft Putty (BioStructures, LLC) Indications For Use: Synthetic Bone Putty is a bone void filler intended for us… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 9 companies; a new generation was cleared every 2.0 years on median.
- 5 of the 44 ancestors have a recall of any class.
- 16 other devices also cite its predicate K140375.
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. 2022, 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?
Synthetic Bone Putty is a bone void filler intended for use in bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created or a result of traumatic injury to the bone. Synthetic Bone Putty is indicated to be packed gently into bony voids or gaps of the pelvis and posterolateral spine and may be used either standalone or in combination with autograft as a bone graft extender. The device is resorbed and replaced with host bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221644 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221644: Synthetic Bone Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221644
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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