The United States Food and Drug Administration (FDA) has granted Integra LifeSciences 510(k) clearance to market Accell Evo3 Demineralized Bone Matrix.
Accell Evo3 Demineralized Bone Matrix is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure.
The product is indicated for use as a bone graft extender in the spine, extremities and pelvis.
It may also be used as bone void filler in the posterolateral spine, extremities and pelvis.
In a pivotal animal study, Accell Evo3 Demineralized Bone Matrix demonstrated effective bone formation and achieved bilateral fusion at 12 weeks, when tested in the posterolateral rabbit spine model.
Radiographic, histologic and biomechanical analyses showed that Accell Evo3 Demineralized Bone Matrix performed as well as autograft, which served as the basis for the Pre-Market Notification decision.