510(k) · Cleared
ClearedSygnal DBM
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 Aug 28, 2008 after a 196-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Aug 28, 2008
- Review
- 196 days
- Class
- Class II
- Product code
- MBP
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK080405 Sygnal DBMMusculoskeletal Transplant Foundation · 2008
- Descendant · cites it directly · 1 of its ownK091217 DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation · 2009
- Descendant · 2 generations on · 0 of its ownK130235 Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II PuttyHans Biomed Corp. · 2014
- Descendant · cites it directly · 0 of its ownK091218 DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation · 2009
Most influential descendants
Showing 3 of 3 · See all- K091217DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation · 2009 · cites it directly1descendant
- K130235Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II PuttyHans Biomed Corp. · 2014 · 2 generations on0descendants
- K091218DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080405 | Sygnal DBM | Musculoskeletal Transplant Foundation | 2008 | — |
| +1 | K091217 | DBX Demineralized Bone Matrix Putty | Musculoskeletal Transplant Foundation | 2009 | — |
| +2 | K130235 | Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II Putty | Hans Biomed Corp. | 2014 | — |
| +1 | K091218 | DBX Demineralized Bone Matrix Putty | Musculoskeletal Transplant Foundation | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2014 | 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?
The FDA summary names no predicate by number.
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?
- Of its descendants, K091217 (Musculoskeletal Transplant Foundation, 2009) has gone furthest, with 1 descendant of its own.
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?
Sygnal DBM is a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Sygnal DBM can be used alone or as an extender in the posterolateral spine with bone marrow. It is indicated for use in the treatment of surgically-created osseous defects or osseous defects created from traumatic injury.
Sygnal DBM is for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080405: Sygnal DBM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080405
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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