# K080405: Sygnal DBM

- Pathway: 510(k) (Traditional)
- Applicant: Musculoskeletal Transplant Foundation
- Decided: Aug 28, 2008 after 196 days
- Product code: MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor))
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K091217: DBX Demineralized Bone Matrix Putty (2009), 1 descendant of its own
- K130235: Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II Putty (2014), 0 descendants of its own
- K091218: DBX Demineralized Bone Matrix Putty (2009), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K080405
Methodology: https://510kreport.com/methodology