Lipogems Gains FDA Clearance for Adipose Tissue Transplant

By Julie A. Vetalice

Lipogems received FDA 510(k) clearance to market a Microfragmented Adipose Tissue Transplant system for use in orthopaedic and arthroscopic procedures.

Lipogems is packaged as a comprehensive kit and uses a minimally invasive procedure to harvest, concentrate, then transfer autologous adipose tissue, typically from the patient's lower torso. The procedure can be performed in an office or surgical setting in under an hour. After a saline rinse to remove contaminants, the system resizes ("microfragments") the tissue to an optimal size to support repair, replacement or reconstruction of injured tissue.

Source: Lipogems

Product Labels: PRP/Cell-Based/Osteoinductive Materials

Tags: 510(k) Clearance, Regulatory