In2Bones Gets FDA’s 510(k) Clearance for Pre-Surgery Software, 3D Cutting Guides

In2Bones Global, a Memphis, Tenn.-based developer and manufacturer of bone and joint restoration products, has received the FDA’s 510(k) clearance for its OrthoPlanify patient-specific planning software and 3D-printed cutting guides.

The Orthoplanify software, which integrates patient computed tomography scans and X-rays, is designed to help surgeons modify and manipulate placement of the total ankle system implant before surgery. And the system’s custom 3D-printed cutting guides enable precision bone cuts and accurate implant alignment during surgery.

The planning software and 3D-printed cutting guides are components of the company’s Quantum total ankle system for arthritis patients.