# K181306: Actifuse Flow

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corporation
- Decided: Aug 17, 2018 after 92 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: 6 generations back to K960978 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082073: Actifuse Flow Bone Graft Substitute, Apatech, Ltd. (2008) Summary page 5.

## Indications for use
Actifuse™ Flow is a bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse™ Flow can be injected into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in posterolateral spinal fusion procedures with appropriate stabilizing hardware. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Source page: https://510kreport.com/device/K181306
Methodology: https://510kreport.com/methodology