510(k) · Cleared
ClearedDynagraft II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isotis Orthobiologics, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Mar 25, 2005 as substantially equivalent to K040980 (Wrightmedicaltechnologyinc, 2004) and 1 other predicate after a 401-day review. Its family tree reaches back 1 generation to 2004. 28 later devices descend from it.
- Decided
- Mar 25, 2005
- Review
- 401 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K040980 (2004). 2 ancestors in all. 28 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK040980 Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty…Wrightmedicaltechnologyinc · 2004
- This deviceK040419 Dynagraft IIIsotis Orthobiologics, Inc. · 2005
- Descendant · cites it directly · 8 of its ownK050642 Orthoblast II Putty and PasteIsotis Orthobiologics, Inc. · 2005
- Descendant · cites it directly · 6 of its ownK050690 ConnexusIsotis Orthobiologics, Inc. · 2005
- Descendant · cites it directly · 5 of its ownK061880 Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCIsotis NV · 2007
- Descendant · cites it directly · 4 of its ownK113728 Surfuse Gel and Putty, Exfuse Gel and PuttyHans Biomed Corp. · 2012
- Descendant · 2 generations on · 4 of its ownK072265 Progenix DMB PuttyMedtronic Sofamor Danek · 2008
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K050642Orthoblast II Putty and PasteIsotis Orthobiologics, Inc. · 2005 · cites it directly8descendants
- K050690ConnexusIsotis Orthobiologics, Inc. · 2005 · cites it directly6descendants
- K061880Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCIsotis NV · 2007 · cites it directly5descendants
- K113728Surfuse Gel and Putty, Exfuse Gel and PuttyHans Biomed Corp. · 2012 · cites it directly4descendants
- K072265Progenix DMB PuttyMedtronic Sofamor Danek · 2008 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040980 | Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite… | Wrightmedicaltechnologyinc | 2004 | — |
| 0 (this device) | K040419 | Dynagraft II | Isotis Orthobiologics, Inc. | 2005 | — |
| +1 | K050642 | Orthoblast II Putty and Paste | Isotis Orthobiologics, Inc. | 2005 | — |
| +1 | K050690 | Connexus | Isotis Orthobiologics, Inc. | 2005 | — |
| +1 | K061880 | Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC | Isotis NV | 2007 | — |
| +1 | K113728 | Surfuse Gel and Putty, Exfuse Gel and Putty | Hans Biomed Corp. | 2012 | — |
| +2 | K072265 | Progenix DMB Putty | Medtronic Sofamor Danek | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K040980 | Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite Scaffold… Cleared while this submission was under review Summary page 1…t bone void filler device. 3. Predicate Devices AlloMatrix ® DBM Putty with inert carrier Sodium Carboxymethylcellulouse (K040980) InterGro® DBM with inert carrier Lecithin (K031399) 4. Device Description DynaGraft I is derived from selecte… | 2004 |
| * | K031399 | Intergro DBM Cleared while this submission was under review Summary page 1…ce. 3. Predicate Devices AlloMatrix ® DBM Putty with inert carrier Sodium Carboxymethylcellulouse (K040980) InterGro® DBM with inert carrier Lecithin (K031399) 4. Device Description DynaGraft I is derived from selected donated human bone tissue that has been a processe… | 2005 |
What descends from it? (28)
See all 288 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050642 | Orthoblast II Putty and Paste | 2005 | 8 |
| K050690 | Connexus | 2005 | 6 |
| K061880 | Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC | 2007 | 5 |
| K113728 | Surfuse Gel and Putty, Exfuse Gel and Putty | 2012 | 4 |
| K091193 | Accell EVO3C | 2009 | 2 |
| K082419 | Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1 | 2009 | 2 |
| K071849 | Allofuse Gel and Putty | 2008 | 1 |
| K070751 | Orthoblast II DBM Demineralized Bone Matrix Paste and Putty | 2007 | 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?
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?
DynaGraft® II is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. DynaGraft® II is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender (extremities, spine, pelvis) and as bony void filler of the extremities and pelvis. These defects may be surgically created or from the result of traumatic injury to the bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040419 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040419: Dynagraft II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040419
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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