Osseus Fusion Gains FDA Clearance for 3D-Printed Lumbar IBFs

By Julie A. Vetalice

Osseus Fusion Systems received FDA 510(k) clearance to market Aries, a line of 3D-printed titanium lumbar interbody fusion devices.

The system includes designs for lateral, anterior, oblique, straight and curved transforaminal procedures in a range of footprints, heights and lordotic angles, and reportedly represents the largest clearance for a family of 3D-printed lumbar interbodies to date. The devices feature up to 80% porosity and a proprietary mesh lattice structure that reduces stiffness and optimizes the ability to pack in bone graft.

Osseus' other technologies include the Black Diamond Pedicle Screw, White Pearl Preferred Angle Anterior Cervical Plate, Gemini-C Hybrid Cervical Interbody (featuring porous titanium wafers with a radiolucent PEEK core), etc.

Source: Osseus Fusion Systems

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory