# K193513: SIGNAFUSE Bioactive Bone Graft

- Pathway: 510(k) (Traditional)
- Applicant: Bioventus
- Decided: Jun 18, 2020 after 182 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- 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
Longest line of descent: 8 generations back to K960978 (1996). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160446: MCP Bone Putty, Biostructures, LLC (2016) Summary page 5.
- K112857: Interface Bone Void Filler, Biostructures, LLC (2011) Summary page 5.

## Indications for use
SIGNAFUSE Bioactive Bone Graft is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. SIGNAFUSE Bioactive Bone Graft is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, SIGNAFUSE Bioactive Bone Graft is to be used as an autograft extender. The device resorbs and is replaced by host bone during the healing process.

Source page: https://510kreport.com/device/K193513
Methodology: https://510kreport.com/methodology