Ventris Medical Receives 510(k) Clearance for Synthetic Bone Graft Putty

Ventris Medical has received 510(k) clearance from the FDA for Synthetic Bone Graft Putty, also known as Amplify.

The company said Amplify represents a new class of synthetic biomaterials designed for the optimization of cell proliferation and bone formation. It is comprised of Amplify biphasic (HA/βTCP) ceramic granules suspended in an alkylene oxide polymer carrier. 

Amplify, which the company says nourishes the bone fusion site in the early stages of healing and supports progressive bone remodeling throughout the fusion process, can be used either alone or in combination with autograft bone as a bone graft extender, Ventris said.

The Newport Beach, Calif., company focuses on developing items for tissue regeneration and bioresorbable bone graft products for spinal and orthopedic fusion procedures.