510(k) · Cleared
Recalled · Class II · 2014Allofuse Gel and Putty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allosource, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Dec 4, 2008 as substantially equivalent to K040419 (Isotis Orthobiologics, Inc., 2005) and 1 other predicate after a 518-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 4, 2008
- Review
- 518 days
- Class
- Class II
- Product code
- MQV
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K040980 (2004). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK040980 Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty…Wrightmedicaltechnologyinc · 2004
- 1 generation backK040419 Dynagraft IIIsotis Orthobiologics, Inc. · 2005
- This deviceK071849 Allofuse Gel and PuttyAllosource, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK103036 Allofuse PlusAllosource, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K103036Allofuse PlusAllosource, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K040980 | Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite… | Wrightmedicaltechnologyinc | 2004 | — |
| −1 | K040419 | Dynagraft II | Isotis Orthobiologics, Inc. | 2005 | — |
| 0 (this device) | K071849 | Allofuse Gel and Putty | Allosource, Inc. | 2008 | — |
| +1 | K103036 | Allofuse Plus | Allosource, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K040419 | Dynagraft IISummary page 1…ble calcium salt bone void filler device (21 CFR 888.3045) MQV, MBP Predicate Device: DynaGraft ® II K040419 AlloMatrix® Putty K041168 Device Description: AlloFuse ® is derived from selected donated huma… | 2005 |
| * | K041168 | Allomatrix PuttySummary page 1…(21 CFR 888.3045) MQV, MBP Predicate Device: DynaGraft ® II K040419 AlloMatrix® Putty K041168 Device Description: AlloFuse ® is derived from selected donated human bone tissue that has been processed into particles. The bo… | 2004 |
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 |
|---|---|---|---|
| K103036 | Allofuse Plus | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 25, 2014 | Class II | Z-1562-2014 | Process control | The donor was hemodiluted. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K103036 (Allosource, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K040419.
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. 2008, 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?
AlloFuse® is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse® is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender (extremities, spine, and 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/K071849 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071849: Allofuse Gel and Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071849
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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