510(k) · Cleared
ClearedDBX-H Hemostatic Demineralized Bone Matrix Putty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthocon, Inc. · MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Cleared on Feb 8, 2007 as substantially equivalent to K040262 (Musculoskeletal Transplant Foundation, 2005) and 1 other predicate after a 290-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Feb 8, 2007
- Review
- 290 days
- Class
- Class II
- Product code
- MBP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K040262 (2005). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK040262 DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone…Musculoskeletal Transplant Foundation · 2005 · Recalled
- This deviceK061131 DBX-H Hemostatic Demineralized Bone Matrix PuttyOrthocon, Inc. · 2007
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) | K061131 | DBX-H Hemostatic Demineralized Bone Matrix Putty | Orthocon, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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? (2)
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 1…s II Predicate Devices DBX® Demineralized Bone Matrix Putty Musculoskeletal Transplant Foundation 510(k) K040262 Grafton DBM Osteotech, Inc. 510(k) K051195 Description DBX-H Hem… | 2005 |
| * | K051195 | Grafton DBMSummary page 1…culoskeletal Transplant Foundation 510(k) K040262 Grafton DBM Osteotech, Inc. 510(k) K051195 Description DBX-H Hemostatic Demineralized Bone Matrix Putty is processed human bone that has been demineralized and combined wi… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- 2 of the 2 ancestors have a recall of any class.
- 12 other devices also cite its predicate K040262.
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. 2007, 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-HTM Hemostatic Demineralized Bone Matrix Putty is indicated for use for filling voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the extremities and pelvis.
DBX-HTM can help control bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used for treatment of surgically created osseous defects and in osseous defects resulting from traumatic injury.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061131 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061131: DBX-H Hemostatic 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/K061131
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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