510(k) Report

510(k) · Cleared

Cleared

DBX Demineralized Bone Matrix Putty

K103795510(k) TraditionalCleared Apr 13, 2011107-day reviewClass II21 CFR 888.3045

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 Apr 13, 2011 as substantially equivalent to K040262 (Musculoskeletal Transplant Foundation, 2005) after a 107-day review. Its family tree reaches back 1 generation to 2005. 6 later devices descend from it.

Decided
Apr 13, 2011
Review
107 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K040262 (2005). 6 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2013: 2 descendants cleared2012: 2 descendants cleared2025: 1 descendant cleared2015: 1 descendant clearedK040262 · DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix Mix · Musculoskeletal Transplant Foundation · 2005 · recalled20052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 2 descendants K040262 · DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix Mix · Musculoskeletal Transplant Foundation · 2005 · recalled0
  1. Root · 1 generation backK040262 DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone…Musculoskeletal Transplant Foundation · 2005 · Recalled
  2. This deviceK103795 DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation · 2011
  3. Descendant · cites it directly · 3 of its ownK113167 MTF New Bone Voild FillerMusculoskeletal Transplant Foundation · 2012
  4. Descendant · cites it directly · 1 of its ownK130498 Osteoselect Demineralized Bone Matrix PuttyBacterin International, Inc. · 2013 · Recalled
  5. Descendant · cites it directly · 1 of its ownK121989 Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC)…Exactech, Inc. · 2012
  6. Descendant · 2 generations on · 0 of its ownK241555 Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc. · 2025
  7. Descendant · 2 generations on · 0 of its ownK150621 OsteoSelect PLUS Demineralized Bone Matrix PuttyBacterin International, Inc. · 2015

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2012: 22013: 22015: 12025: 1
2012high 2 (2012) · low 0 (2014)2026

Most influential descendants

Showing 5 of 6 · See all
  • K113167MTF New Bone Voild FillerMusculoskeletal Transplant Foundation · 2012 · cites it directly3descendants
  • K130498Osteoselect Demineralized Bone Matrix PuttyBacterin International, Inc. · 2013 · cites it directly1descendant
  • 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
  • K150621OsteoSelect PLUS Demineralized Bone Matrix PuttyBacterin International, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K040262DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix MixMusculoskeletal Transplant Foundation20052
0 (this device)K103795DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation2011—
+1K113167MTF New Bone Voild FillerMusculoskeletal Transplant Foundation2012—
+1K130498Osteoselect Demineralized Bone Matrix PuttyBacterin International, Inc.20131
+1K121989Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure +…Exactech, Inc.2012—
+2K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc.2025—
+2K150621OsteoSelect PLUS Demineralized Bone Matrix PuttyBacterin International, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201320
201510
202510
FIG. 1 — Lineage of K103795, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K040262DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix Mix
Summary page 2
…tific technology of the DBX® Putty with expanded indications for use in the posterolateral spine is the same as the technology for the predicate DBX® Putty (FDA cleared, K040262). Biocompatibility of DBX®D materials has been established through their long history of safe and effective clinical use, furthe…
Musculoskeletal Transplant Foundation20052

Also cleared against K040262: 12 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K113167MTF New Bone Voild FillerMusculoskeletal Transplant Foundation20123
K130498Osteoselect Demineralized Bone Matrix PuttyBacterin International, Inc.20131
K121989Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone…Exactech, Inc.20121
K121313MTF New Bone Void FillerMusculoskeletal Transplant Foundation20130

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?

  • Its one ancestor has a recall.
  • Of its descendants, K113167 (Musculoskeletal Transplant Foundation, 2012) has gone furthest, with 3 descendants of its own.
  • 12 other devices also cite its predicate K040262.

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. 2011, this device’s year, is highlighted.

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 Putty is intended for use as a Demnineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX Putty is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX Putty can be used alone in the posterolateral spine. DBX Putty can also be used as an extender in the spine with autograft or allograft. DBX Putty can be used with bone marrow. DBX Putty…

Read the full statement (172 words)

DBX Putty is intended for use as a Demnineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX Putty is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.

DBX Putty can be used alone in the posterolateral spine. DBX Putty can also be used as an extender in the spine with autograft or allograft. DBX Putty can be used with bone marrow. DBX Putty is for single patient use only.

DBX Inject is intended for use as a Demnineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.

DBX Inject can be used alone in the posterolateral spine. DBX Inject can also be used as an extender in the spine with autograft or allograft. DBX Inject can be used with bone marrow. DBX Inject is for single patient use only.

Indications for use as stated in the FDA summary.

Also cleared against K040262

12 other devices cite the same predicate.

  • K121313MTF New Bone Void FillerMusculoskeletal Transplant Foundation · 2013
  • K113167MTF New Bone Voild FillerMusculoskeletal Transplant Foundation · 2012
  • K103784DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation · 2011
  • K091217DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation · 2009
  • K091218DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation · 2009
  • K091321Osteoselect Demineralized Bone Matrix PuttyBacterin International, Inc. · 20092 recalls

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

  • K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc. · 2026
  • 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/K103795 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103795: DBX Demineralized Bone Matrix Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103795

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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