510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix Mix

K040262510(k) TraditionalCleared Mar 17, 2005407-day reviewClass II21 CFR 888.3045Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Musculoskeletal Transplant Foundation · MQV Filler, Bone Void, Calcium Compound

Cleared on Mar 17, 2005 after a 407-day review. The FDA summary names no predicate by number. 28 later devices descend from it. It has been recalled 2 times.

Decided
Mar 17, 2005
Review
407 days
Class
Class II
Product code
MQV
Recalls
2
Predicates
0

28 later devices descend from it, 13 citing it directly.

Descendants, by year cleared 2009: 3 descendants cleared2008: 6 descendants cleared2011: 3 descendants cleared2007: 1 descendant cleared2006: 3 descendants cleared2012: 2 descendants cleared2013: 2 descendants cleared2015: 2 descendants cleared2014: 1 descendant cleared2018: 1 descendant cleared2025: 2 descendants cleared2017: 1 descendant cleared2024: 1 descendant cleared20052010201520202025
  1. This deviceK040262 DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone…Musculoskeletal Transplant Foundation · 2005
  2. Descendant · cites it directly · 9 of its ownK060794 Progenix DBM Putty and PasteMedtronic Sofamor Danek · 2006
  3. Descendant · cites it directly · 7 of its ownK103784 DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation · 2011
  4. Descendant · cites it directly · 6 of its ownK103795 DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation · 2011
  5. Descendant · cites it directly · 4 of its ownK080399 DBX Demineralized Bone Matrix Putty, DBX Demineralized Bone Matrix…Musculoskeletal Transplant Foundation · 2008
  6. Descendant · cites it directly · 4 of its ownK072265 Progenix DMB PuttyMedtronic Sofamor Danek · 2008

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2006: 32007: 12008: 62009: 32011: 32012: 22013: 22014: 12015: 22017: 12018: 12024: 12025: 2
2006high 6 (2008) · low 0 (2010)2026

Most influential descendants

Showing 5 of 28 · See all
  • K060794Progenix DBM Putty and PasteMedtronic Sofamor Danek · 2006 · cites it directly9descendants
  • K103784DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation · 2011 · cites it directly7descendants
  • K103795DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation · 2011 · cites it directly6descendants
  • K080399DBX Demineralized Bone Matrix Putty, DBX Demineralized Bone Matrix PasteMusculoskeletal Transplant Foundation · 2008 · cites it directly4descendants
  • K072265Progenix DMB PuttyMedtronic Sofamor Danek · 2008 · cites it directly4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K040262DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix MixMusculoskeletal Transplant Foundation2005—
+1K060794Progenix DBM Putty and PasteMedtronic Sofamor Danek2006—
+1K103784DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation2011—
+1K103795DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation2011—
+1K080399DBX Demineralized Bone Matrix Putty, DBX Demineralized Bone Matrix PasteMusculoskeletal Transplant Foundation2008—
+1K072265Progenix DMB PuttyMedtronic Sofamor Danek2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200630
200710
200860
200930
201130
201220
201320
201410
201520
201710
201810
202410
202520
FIG. 1 — Lineage of K040262, 2005–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (28)

See all 28

13 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K060794Progenix DBM Putty and PasteMedtronic Sofamor Danek20069
K103784DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation20117
K103795DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation20116
K080399DBX Demineralized Bone Matrix Putty, DBX Demineralized Bone Matrix PasteMusculoskeletal Transplant Foundation20084
K072265Progenix DMB PuttyMedtronic Sofamor Danek20084
K113167MTF New Bone Voild FillerMusculoskeletal Transplant Foundation20123
K091321Osteoselect Demineralized Bone Matrix PuttyBacterin International, Inc.20092
K053218DBX Demineralized Bone Matrix Putty/Paste/MixMusculoskeletal Transplant Foundation20062
K061668Optecure +CCCExactech, Inc.20062
K091217DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation20091

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 22, 2023Class IIZ-0323-2024Labeling Change ControlUnits are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery.
Dec 4, 2014Class IIZ-1455-2015Packaging process controlThe seal on the DBX Mix outer PETG/Aclar tray with foil lid packaging for lot identified above may not be fully intact.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K060794 (Medtronic Sofamor Danek, 2006) has gone furthest, with 9 descendants of its own.

How does its category compare?

All MQV devices

MQV Filler, Bone Void, Calcium Compound: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQV

14in 2025

2007: 352008: 322009: 232010: 172011: 162012: 92013: 122014: 202015: 182016: 82017: 172018: 232019: 132020: 152021: 82022: 92023: 212024: 282025: 142026 (partial year): 5
2007high 35 (2007) · low 8 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQV

57in 2025

2007: 144 days median2008: 102 days median2009: 180 days median2010: 147 days median2011: 92 days median2012: 107 days median2013: 197 days median2014: 153 days median2015: 184 days median2016: 214 days median2017: 124 days median2018: 124 days median2019: 90 days median2020: 132 days median2021: 88 days median2022: 118 days median2023: 74 days median2024: 55 days median2025: 57 days median2026 (partial year): 96 days median
2007high 214 (2016) · low 55 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQV

1in 2025

2007: 52008: 32009: 12011: 62012: 32013: 22016: 12017: 12018: 22020: 12023: 32024: 22025: 12026 (partial year): 4
2007high 6 (2011) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQV

57in 2025

2007: 672008: 712009: 812010: 682011: 1142012: 1492013: 2232014: 1112015: 1252016: 1062017: 1072018: 862019: 652020: 1262021: 1012022: 472023: 1202024: 682025: 57
2007high 223 (2013) · low 47 (2022)2025

MAUDE reports naming product code MQV, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735144567
200832102371
200923180181
201017147068
201116926114
201291073149
2013121972223
2014201530111
2015181840125
201682141106
2017171241107
201823124286
20191390065
2020151321126
20218880101
20229118047
202321743120
20242855268
20251457157
20265964—

What is it indicated for?

DBX® Demineralized Bone Matrix is intended for use as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. DBX® Putty can be used to fill bone voids in the extremities, posterolateral spine, pelvis and cranium. DBX® Paste and Mix can be used to fill bone voids in the extremities and pelvis. It is indicated for use in the treatment of surgically-created osseous defects or osseous defects created from traumatic injury.

Indications for use as stated in the FDA summary.

More from Musculoskeletal Transplant Foundation

24 FDA decisions under this applicant name. See the company

  • K181633MTF Pre-Sutured TendonMusculoskeletal Transplant Foundation · 20191 recall
  • K121313MTF New Bone Void FillerMusculoskeletal Transplant Foundation · 2013
  • K120479MTF FasciaMusculoskeletal Transplant Foundation · 2012
  • K113167MTF New Bone Voild FillerMusculoskeletal Transplant Foundation · 2012
  • K110003MTF New Bone Void FillerMusculoskeletal Transplant Foundation · 2011

Recent decisions in MQV

The MQV category page

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  • K260364Device 300419 StripGeistlich Pharma AG · 2026
  • K252797JAZBI™ Resorbable Bone Void FillerSdip Innovations Pty, Ltd. · 2026
  • K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2026
  • K253524Adaptos®Fuse Bone GraftBiomendex OY · 2026

https://510kreport.com/device/K040262 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040262: DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix Mix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040262

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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