510(k) · Cleared
Recalled · Class II · 2016WMT Composite DBM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · MQV Filler, Bone Void, Calcium Compound
Cleared on Aug 27, 2009 after a 294-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled once.
- Decided
- Aug 27, 2009
- Review
- 294 days
- Class
- Class II
- Product code
- MQV
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK083270 WMT Composite DBMWrightmedicaltechnologyinc · 2009
- Descendant · cites it directly · 2 of its ownK190283 PROSTIM Injectable Inductive GraftWrightmedicaltechnologyinc · 2019
- Descendant · 2 generations on · 1 of its ownK200507 PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2020
- Descendant · 3 generations on · 0 of its ownK213342 PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2022
Most influential descendants
Showing 3 of 3 · See all- K190283PROSTIM Injectable Inductive GraftWrightmedicaltechnologyinc · 2019 · cites it directly2descendants
- K200507PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2020 · 2 generations on1descendant
- K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083270 | WMT Composite DBM | Wrightmedicaltechnologyinc | 2009 | — |
| +1 | K190283 | PROSTIM Injectable Inductive Graft | Wrightmedicaltechnologyinc | 2019 | — |
| +2 | K200507 | PRO-DENSE LoVisc Bone Graft Substitute | Wrightmedicaltechnologyinc | 2020 | — |
| +3 | K213342 | PRO-DENSE LoVisc Bone Graft Substitute | Wrightmedicaltechnologyinc | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | — | Allomatrix Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190283 | PROSTIM Injectable Inductive Graft | 2019 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 8, 2016 | Class II | Z-0564-2020 | Process control | The firm discovered a lack of adequate documentation confirming sterility on certain products. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K190283 (Wrightmedicaltechnologyinc, 2019) 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. 2009, 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?
WMT Composite DBM resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in-situ. These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs…
Read the full statement (211 words)
WMT Composite DBM resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in-situ. These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
The WMT Composite DBM paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
The WMT Composite DBM Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced by bone during the healing process. The bone void filler included in the WMT Composite DBM Core Decompression Kit is not intended to be used as a load bearing device.
WMT Composite DBM is provided sterile for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083270 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083270: WMT Composite DBM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083270
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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