510(k) · Cleared
Recalled · Class II · 2020Stimulan Kit, Stimulan Rapid Cure
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 Jan 23, 2015 as substantially equivalent to K021551 (Biocomposites, Ltd., 2002) after a 200-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it. It has been recalled once.
- Decided
- Jan 23, 2015
- Review
- 200 days
- Class
- Class II
- Product code
- MQV
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021551 (2002). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK021551 Stimulan - Calcium Sulfate Bone Void Filler KitBiocomposites, Ltd. · 2002
- This deviceK141830 Stimulan Kit, Stimulan Rapid CureBiocomposites, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK250141 Synthecure Synthetic Calcium SulfateAustin Medical Ventures, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK171161 Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)Dimensional Bioceramics, LLC · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021551 | Stimulan - Calcium Sulfate Bone Void Filler Kit | Biocomposites, Ltd. | 2002 | — |
| 0 (this device) | K141830 | Stimulan Kit, Stimulan Rapid Cure | Biocomposites, Ltd. | 2015 | — |
| +1 | K250141 | Synthecure Synthetic Calcium Sulfate | Austin Medical Ventures, Inc. | 2025 | — |
| +1 | K171161 | Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) | Dimensional Bioceramics, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (1)
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 |
|---|---|---|---|
| * | K021551 | Stimulan - Calcium Sulfate Bone Void Filler KitSummary page 4…Common Name: Bone Void Filler Classification: 21 CFR 888.3045 – Class II Product Code/Panel: MQV/Orthopedic 3. Pimary Predicate Device: K021551- Stimulan Kit 7.1… | 2002 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 12, 2020 | Class II | Z-0638-2021 | Labeling mix-ups | The product is mislabeled. |
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. 2015, 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?
Stimulan Kit/Stimulan Rapid Cure is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be swrgically created or created from traumatic injury to the bone. Stimulan Kit/Stimulan Rapid Cure is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities, pelvis, and posterolateral spine). Stimulan Kit/Stimulan Rapid Cure provides…
Read the full statement (124 words)
Stimulan Kit/Stimulan Rapid Cure is intended for use as a bone void filler for voids or gaps that are not intrinsic to the
stability of the bony structure. These osseous defects may be swrgically created or created from traumatic injury to the
bone. Stimulan Kit/Stimulan Rapid Cure is intended to be gently packed into bony voids or gaps of the skeletal system
(i.e., extremities, pelvis, and posterolateral spine). Stimulan Kit/Stimulan Rapid Cure provides a bone graft substitute that
resorbs and is replaced with bone during the healing process. Stimulan Kit/Stimulan Rapid Cure is biodegradable and
biocompatible and may be used at an infected site.
To fill a bone void or defect created by:
« surgery
* acyst
* atumour
* osteomyelitis
« traumatic injury
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141830 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141830: Stimulan Kit, Stimulan Rapid Cure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141830
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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