510(k) · Cleared
ClearedStimulan - Calcium Sulfate Bone Void Filler Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocomposites, Ltd. · MQV Filler, Bone Void, Calcium Compound
Cleared on Nov 1, 2002 after a 172-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Nov 1, 2002
- Review
- 172 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK021551 Stimulan - Calcium Sulfate Bone Void Filler KitBiocomposites, Ltd. · 2002
- Descendant · cites it directly · 2 of its ownK141830 Stimulan Kit, Stimulan Rapid CureBiocomposites, Ltd. · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK250141 Synthecure Synthetic Calcium SulfateAustin Medical Ventures, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK171161 Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)Dimensional Bioceramics, LLC · 2017
- Descendant · cites it directly · 0 of its ownK040600 Genex Bone Graft SubstituteBiocomposites, Ltd. · 2004
Most influential descendants
Showing 4 of 4 · See all- K141830Stimulan Kit, Stimulan Rapid CureBiocomposites, Ltd. · 2015 · cites it directly2descendants
- K250141Synthecure Synthetic Calcium SulfateAustin Medical Ventures, Inc. · 2025 · 2 generations on0descendants
- K171161Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)Dimensional Bioceramics, LLC · 2017 · 2 generations on0descendants
- K040600Genex Bone Graft SubstituteBiocomposites, Ltd. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021551 | Stimulan - Calcium Sulfate Bone Void Filler Kit | Biocomposites, Ltd. | 2002 | — |
| +1 | K141830 | Stimulan Kit, Stimulan Rapid Cure | Biocomposites, Ltd. | 2015 | 1 |
| +2 | K250141 | Synthecure Synthetic Calcium Sulfate | Austin Medical Ventures, Inc. | 2025 | — |
| +2 | K171161 | Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) | Dimensional Bioceramics, LLC | 2017 | — |
| +1 | K040600 | Genex Bone Graft Substitute | Biocomposites, Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K141830 (Biocomposites, Ltd., 2015) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K021551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021551: Stimulan - Calcium Sulfate 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/K021551
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026