510(k) · Cleared
ClearedDBX Demineralized Bone Matrix Putty, DBX Demineralized Bone Matrix Paste
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Musculoskeletal Transplant Foundation · MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Cleared on Oct 10, 2008 as substantially equivalent to K040262 (Musculoskeletal Transplant Foundation, 2005) after a 239-day review. Its family tree reaches back 1 generation to 2005. 4 later devices descend from it.
- Decided
- Oct 10, 2008
- Review
- 239 days
- Class
- Class II
- Product code
- MBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040262 (2005). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK040262 DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone…Musculoskeletal Transplant Foundation · 2005 · Recalled
- This deviceK080399 DBX Demineralized Bone Matrix Putty, DBX Demineralized Bone Matrix…Musculoskeletal Transplant Foundation · 2008
- Descendant · cites it directly · 3 of its ownK110003 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 · 2 generations on · 0 of its ownK121313 MTF New Bone Void FillerMusculoskeletal Transplant Foundation · 2013
Most influential descendants
Showing 4 of 4 · See all- K110003MTF New Bone Void FillerMusculoskeletal Transplant Foundation · 2011 · cites it directly3descendants
- 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 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040262 | DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix Mix | Musculoskeletal Transplant Foundation | 2005 | 2 |
| 0 (this device) | K080399 | DBX Demineralized Bone Matrix Putty, DBX Demineralized Bone Matrix Paste | Musculoskeletal Transplant Foundation | 2008 | — |
| +1 | 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 | — |
| +2 | K121313 | MTF New Bone Void Filler | Musculoskeletal Transplant Foundation | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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 MBP? 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 MBP device
- #1 K242799 PliaFX Floscore 9.0 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K040262 | DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix MixSummary page 2…using BMP -2 in vitro testing as an alternative for in vivo testing for osteoinductivity, is the same as the technology for the unmodified predicate, DBX® (FDA cleared, K040262). Biocompatibility of DBX® materials has been established through their long history of safe and effective clinical use, further… | 2005 |
What descends from it? (4)
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?
How does its category compare?
All MBP devicesMBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MBP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MBP
181in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBP
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBP
2in 2025
MAUDE reports naming product code MBP, 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 | 5 | 188 | 0 | 7 |
| 2008 | 5 | 93 | 0 | 15 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 1 | — | 2 | 18 |
| 2012 | 1 | — | 13 | 24 |
| 2013 | 3 | 181 | 0 | 16 |
| 2014 | 0 | — | 1 | 15 |
| 2015 | 1 | — | 0 | 11 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 7 | 6 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
DBX® is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the:
Putty: Extremities, Pelvis, Posterolateral Spine, Cranium
Mix: Extremities, Pelvis, Spine
Paste: Extremities, Pelvis
DBX® is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Putty can be used as an extender in the spine with autograft. DBX® can be used with bone marrow. DBX® is for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080399 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080399: DBX Demineralized Bone Matrix Putty, DBX Demineralized Bone Matrix Paste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080399
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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