510(k) · Cleared
ClearedDB-Composite
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 Mar 15, 2021 as substantially equivalent to K112383 (Skeletal Kinetics, LLC, 2012) after a 49-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Mar 15, 2021
- Review
- 49 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011897 (2001). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK011897 Norian SRS Bone Void FillerSynthes (Usa) · 2001
- 3 generations backK030554 CallosSkeletal Kinetics, LLC · 2003
- 2 generations backK051123 Callos Impact and Inject Bone Void FillerSkeletal Kinetics, LLC · 2005 · Recalled
- 1 generation backK112383 Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone…Skeletal Kinetics, LLC · 2012 · Recalled
- This deviceK210193 DB-CompositeDimensional Bioceramics, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011897 | Norian SRS Bone Void Filler | Synthes (Usa) | 2001 | — |
| −3 | K030554 | Callos | Skeletal Kinetics, LLC | 2003 | — |
| −2 | K051123 | Callos Impact and Inject Bone Void Filler | Skeletal Kinetics, LLC | 2005 | 17 |
| −1 | K112383 | Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone Void Filler | Skeletal Kinetics, LLC | 2012 | 3 |
| 0 (this device) | K210193 | DB-Composite | Dimensional Bioceramics, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K112383 | Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone Void FillerSummary page 4…duct Code MQV Regulatory Class Class 2 III. PREDICATE AND REFERENCE DEVICES Predicate Device K112383, Skeletal Kinetics, Callos ProModel Bone Void Filler Reference Device… | 2012 |
| † | K182742 | DB-CMF | 2019 |
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 20 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- 2 of the 6 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. 2021, 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?
DB-Composite Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. DB-Composite is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
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/K210193 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210193: DB-Composite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210193
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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