MiRus Earns 510(k) Clearance for 3D-Printed Lumbar Interbody Fusion System

MiRus has received 510(k) clearance from the FDA for its Hyperion 3D randomized, printed lumbar interbody fusion system.

The spinal implant has the same stiffness as cancellous bone, which provides better load sharing, lower risk of subsidence and potentially improved fusion rates, the company said.

The implant uses a randomized lattice structure that mimics the organic structure of bone and  promotes bone growth around the device.