Avitus Orthopaedics Receives 510(k) Clearance, Launches Avitus Bone Harvester

By Julie A. Vetalice

Avitus Orthopaedics launched pilot sales of the Avitus™ Bone Harvester. The product received FDA 510(k) clearance as a Class II medical device, indicated to harvest autologous bone graft and bone marrow in a minimally invasive manner for use in spine and orthopaedic procedures.

CE Mark approval is expected later in 2016, and Avitus is establishing distributor partnerships in the U.S. and EU.

In 3Q16, the company will launch a Series B financing round to support its sales expansion in the U.S. and international markets. Avitus was also awarded a Small Business Innovation Research award from the National Science Foundation to support R&D. In 2014, the company raised >$1MM.

Sources: Avitus Orthopaedics Inc., ORTHOWORLD Inc.

Product Labels: Bone Graft Materials/DBM

Tags: 510(k) Clearance, Product Launch, Regulatory