510(k) · Cleared
ClearedDimensional Bioceramics Calcium Sulfate Device (DB-CSD)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dimensional Bioceramics, LLC · MQV Filler, Bone Void, Calcium Compound
Cleared on Sep 25, 2017 as substantially equivalent to K141830 (Biocomposites, Ltd., 2015) after a 158-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Sep 25, 2017
- Review
- 158 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K021551 (2002). No later device cites it as a predicate yet.
- Root · 2 generations backK021551 Stimulan - Calcium Sulfate Bone Void Filler KitBiocomposites, Ltd. · 2002
- 1 generation backK141830 Stimulan Kit, Stimulan Rapid CureBiocomposites, Ltd. · 2015 · Recalled
- This deviceK171161 Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)Dimensional Bioceramics, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021551 | Stimulan - Calcium Sulfate Bone Void Filler Kit | Biocomposites, Ltd. | 2002 | — |
| −1 | K141830 | Stimulan Kit, Stimulan Rapid Cure | Biocomposites, Ltd. | 2015 | 1 |
| 0 (this device) | K171161 | Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) | Dimensional Bioceramics, LLC | 2017 | — |
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 |
|---|---|---|---|
| * | K141830 | Stimulan Kit, Stimulan Rapid CureSummary page 4…Resorbable Calcium Sulfate Bone Void Filler Classification #: 21 CFR 888.3045 Product Code: MQV III. PREDICATE DEVICE(s) K141830, Stimulan Rapid Cure, Biocomposites, Ltd. IV. DEVICE DESCRIPTION Device Identification, Dimensional Bioceramics (DB)… | 2015 |
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 15 years and passes through 2 companies; a new generation was cleared every 12.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K141830.
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. 2017, 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?
Dimensional Bioceramics™ (DB) Calcium Sulfate Device (CSD) is a bone graft substitute that is intended for use as a bone void filler for voids and gaps and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from a traumatic injury to the bone. DB-CSD is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities and pelvis). DB-CSD is a bone graft substitute that resorbs and replaced with bone during the healing process. DB-CSD is biodegradable and biocompatible and may be used in an infected site.
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/K171161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171161: Dimensional Bioceramics Calcium Sulfate Device (DB-CSD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171161
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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