In2Bones Receives FDA Clearance for Pre-Surgery OrthoPlanify

By Julie A. Vetalice

In2Bones Receives FDA Clearance for Pre-Surgery OrthoPlanify

In2Bones announced FDA clearance of OrthoPlanify™ patient-specific planning software and 3D-printed cutting guides, both part of the company’s QUANTUM®Total Ankle System.

In2Bones’ Orthoplanify software integrates patient CT scans and X-rays, enabling surgeons to easily modify, adjust and manipulate placement of the QUANTUM Total Ankle System implant prior to surgery.

During surgery, the Total Ankle System’s custom 3D-printed cutting guides save surgeons multiple steps and allow for precision bone cuts and more accurate implant alignment when compared with manual instrumentation.

QUANTUM is designed to provide implant stability due to its vertical, cruciate-shaped tibial stem. The talar component, available in flat and chamfer cut options, features an anatomically designed double radius of curvature. This combination is intended to improve function and longevity compared to currently available total ankle products.

Source: In2Bones Global

Product Labels: Ankle Replacement, Surgical Planning

Tags: 510(k) Clearance, Regulatory