# K082073: Actifuse Flow Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Apatech, Ltd.
- Decided: Sep 11, 2008 after 50 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: 5 generations back to K960978 (1996). 8 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071206: Actifuse Abx E-Z-Fil Putty Bone Graft Substitute, Apatech, Ltd. (2007) Summary page 1.

## Most influential descendants
- K180853: EP Granules™ BVF (2018), 1 descendant of its own
- K250346: BonVie+ (2025), 0 descendants of its own
- K181306: Actifuse Flow (2018), 0 descendants of its own
- K090850: Actifuse Bone Graft Substitute, Actifuse Microgranules Bone Graft Substitute (2009), 0 descendants of its own

## Indications for use
Actifuse TM Flow Bone Graft Substitute is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. ActifuseTM Flow Bone Graft Substitute 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/K082073
Methodology: https://510kreport.com/methodology