510(k) · Cleared
ClearedAllofuse Plus
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 Jan 10, 2011 as substantially equivalent to K070751 (Isotis Orthobiologics, Inc., 2007) and 2 other predicates after an 89-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- Jan 10, 2011
- Review
- 89 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K040980 (2004). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK040980 Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty…Wrightmedicaltechnologyinc · 2004
- 3 generations backK040419 Dynagraft IIIsotis Orthobiologics, Inc. · 2005
- 2 generations backK050642 Orthoblast II Putty and PasteIsotis Orthobiologics, Inc. · 2005
- 1 generation backK070751 Orthoblast II DBM Demineralized Bone Matrix Paste and PuttyIsotis Orthobiologics, Inc. · 2007
- This deviceK103036 Allofuse PlusAllosource, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K040980 | Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite… | Wrightmedicaltechnologyinc | 2004 | — |
| −3 | K040419 | Dynagraft II | Isotis Orthobiologics, Inc. | 2005 | — |
| −2 | K050642 | Orthoblast II Putty and Paste | Isotis Orthobiologics, Inc. | 2005 | — |
| −1 | K070751 | Orthoblast II DBM Demineralized Bone Matrix Paste and Putty | Isotis Orthobiologics, Inc. | 2007 | — |
| 0 (this device) | 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 |
| 2008 | 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? (3)
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 |
|---|---|---|---|
| * | K070751 | Orthoblast II DBM Demineralized Bone Matrix Paste and PuttySummary page 1…oid filler device (21 CFR 888.3045) MQV, MBP Predicate Device(s): Ortholast® it 510(k) # K070751, K050642 Allouse Gel and Putty 51 0(k)# K071 849 Device Description: Allouse P… | 2007 |
| * | K050642 | Orthoblast II Putty and PasteSummary page 1…r device (21 CFR 888.3045) MQV, MBP Predicate Device(s): Ortholast® it 510(k) # K070751, K050642 Allouse Gel and Putty 51 0(k)# K071 849 Device Description: Allouse Plus is de… | 2005 |
| * | K071849 | Allofuse Gel and PuttySummary page 1…redicate Device(s): Ortholast® it 510(k) # K070751, K050642 Allouse Gel and Putty 51 0(k)# K071 849 Device Description: Allouse Plus is derived from selected donated human bone tissue that has been processed into particles. The… | 2008 |
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 7 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 7 ancestors have a recall of any class.
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. 2011, 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?
For orthopedic use, AlloFuse Plus Paste and Putty are intended for use as an autograft extender (i.e. extremities, posterolateral spine and pelvis) and as a bone void filler (i.e. extremities and pelvis) for bony voids or gaps that are not intrinsic to the stability of the bony structure. The AlloFuse Plus products are indicated to be packed gently into bony defects of the skeletal system. 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/K103036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103036: Allofuse Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103036
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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