510(k) · Cleared
ClearedMTF New Bone Void Filler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Musculoskeletal Transplant Foundation · MQV Filler, Bone Void, Calcium Compound
Cleared on Oct 13, 2011 as substantially equivalent to K080399 (Musculoskeletal Transplant Foundation, 2008) and 2 other predicates after a 283-day review. Its family tree reaches back 2 generations to 2006. 3 later devices descend from it.
- Decided
- Oct 13, 2011
- Review
- 283 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K042829 (2006). 4 ancestors in all, the oldest K040262 (2005). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK042829 DBX StripMusculoskeletal Transplant Foundation · 2006
- 1 generation backK062205 DBX StripMusculoskeletal Transplant Foundation · 2007
- This deviceK110003 MTF New Bone Void FillerMusculoskeletal Transplant Foundation · 2011
- Descendant · cites it directly · 1 of its ownK121989 Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC)…Exactech, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK241555 Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK121313 MTF New Bone Void FillerMusculoskeletal Transplant Foundation · 2013
Most influential descendants
Showing 3 of 3 · See all- K121989Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone…Exactech, Inc. · 2012 · cites it directly1descendant
- K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc. · 2025 · 2 generations on0descendants
- K121313MTF New Bone Void FillerMusculoskeletal Transplant Foundation · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K042829 | DBX Strip | Musculoskeletal Transplant Foundation | 2006 | — |
| −1 | K062205 | DBX Strip | Musculoskeletal Transplant Foundation | 2007 | — |
| 0 (this device) | K110003 | MTF New Bone Void Filler | Musculoskeletal Transplant Foundation | 2011 | — |
| +1 | K121989 | Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure +… | Exactech, Inc. | 2012 | — |
| +2 | K241555 | Moldable Bone Void Filler and Moldable Bone Void Filler + CCC | Rti Surgical, Inc. | 2025 | — |
| +1 | K121313 | MTF New Bone Void Filler | Musculoskeletal Transplant Foundation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 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? (3)
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 |
|---|---|---|---|
| * | K080399 | DBX Demineralized Bone Matrix Putty, DBX Demineralized Bone Matrix PasteSummary page 1…DBX® Demineralized Bone Matrix Musculoskeletal Transplant Foundation 510(k) K080399 DBX Strip® Musculoskeletal Transplant Foundation… | 2008 |
| * | K042829 | DBX StripSummary page 1…9 DBX Strip® Musculoskeletal Transplant Foundation 510(k) K042829, K062205 Osteoinductive Potential The MTF New Bone Void Filler is osteoconductive and has been shown to have osteoinductive pote… | 2006 |
| * | K062205 | DBX StripSummary page 1…DBX Strip® Musculoskeletal Transplant Foundation 510(k) K042829, K062205 Osteoinductive Potential The MTF New Bone Void Filler is osteoconductive and has been shown to have osteoinductive potential in… | 2007 |
What descends from it? (3)
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?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 4.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K121989 (Exactech, Inc., 2012) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K080399.
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. 2011, 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?
The MTF New Bone Void Filler is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. The MTF New Bone Void Filler is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. It is for use in the posterolateral spine only, for posterolateral spine fusions. The MTF New Bone Void Filler must be used in the spine with bone marrow aspirate.
The MTF New Bone Void Filler is for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110003: MTF New Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110003
Report an extraction error
Are you the manufacturer?
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