510(k) · Cleared
ClearedProfusion Bone Void Filler Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biogeneration · MQV Filler, Bone Void, Calcium Compound
Cleared on Oct 30, 2003 after a 136-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Oct 30, 2003
- Review
- 136 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK031838 Profusion Bone Void Filler KitBiogeneration · 2003
- Descendant · cites it directly · 3 of its ownK051406 Osteocure Resorbable Bead KitNexa Orthopedics, Inc. · 2005
- Descendant · 2 generations on · 2 of its ownK071004 Osteocrete Bone Void FillerBone Solutions, Inc. · 2009
- Descendant · 3 generations on · 1 of its ownK212991 OsteoreviveBone Solutions, Inc. · 2022
- Descendant · 4 generations on · 0 of its ownK221256 Mg OSTEOINJECTBone Solutions, Inc. · 2022
Most influential descendants
Showing 4 of 4 · See all- K051406Osteocure Resorbable Bead KitNexa Orthopedics, Inc. · 2005 · cites it directly3descendants
- K071004Osteocrete Bone Void FillerBone Solutions, Inc. · 2009 · 2 generations on2descendants
- K212991OsteoreviveBone Solutions, Inc. · 2022 · 3 generations on1descendant
- K221256Mg OSTEOINJECTBone Solutions, Inc. · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031838 | Profusion Bone Void Filler Kit | Biogeneration | 2003 | — |
| +1 | K051406 | Osteocure Resorbable Bead Kit | Nexa Orthopedics, Inc. | 2005 | — |
| +2 | K071004 | Osteocrete Bone Void Filler | Bone Solutions, Inc. | 2009 | — |
| +3 | K212991 | Osteorevive | Bone Solutions, Inc. | 2022 | — |
| +4 | K221256 | Mg OSTEOINJECT | Bone Solutions, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | — | ProFusionB Graft Substitute Devices Named without a submission number | |
| * | — | Wright Medical Kits Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051406 | Osteocure Resorbable Bead Kit | 2005 | 3 |
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?
- Of its descendants, K051406 (Nexa Orthopedics, Inc., 2005) has gone furthest, with 3 descendants of its own.
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?
The paste made with the ProFusionG3 Bone Graft Substitute Kits are intended to be injected, digitally packed into bone voids or gaps; or molded into solid pellets that are gently packed into bone voids or gaps that are not intrinsic to the stability of the bony structure of the skeletal system (i.e. long bones, extremities, spine and pelvis). The bone voids or gaps may be either surgically created or result from traumatic injury. The device provides a…
Read the full statement (166 words)
The paste made with the ProFusionG3 Bone Graft Substitute Kits are intended to be injected, digitally packed into bone voids or gaps; or molded into solid pellets that are gently packed into bone voids or gaps that are not intrinsic to the stability of the bony structure of the skeletal system (i.e. long bones, extremities, spine and pelvis). The bone voids or gaps may be either surgically created or result from traumatic injury. The device provides a bone void filler that resorbs and is replaced with bone during the healing process.
ProFusionO3 paste cured in situ provides a bone void or gap filler that can augment provisional hardware (e.9. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary scaffold and is not intended to provide support during the healing process.
ProFusionO3 Bone Graft Substitute Kits are provided sterile for single use only. Because the devices are biodegradable and biocornpatible, they may be used at an infected site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031838: Profusion Bone Void Filler Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031838
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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