Naviswiss Gets FDA’s 510(k) Clearance for Hip Replacement Surgery Planner

Naviswiss has received 510(k) clearance from the FDA for Naviplan, its pre-operative planning software for computed tomography-based total hip replacement surgery.

The software is intended to help orthopedic surgeons improve accuracy and predictability while also documenting the outcome, the Swiss-based company said.

The software assists the surgeon in positioning of the joint implants using 3D segmentation and advanced image processing. It then delivers a pre-operative plan to the company’s navigation platform for accurate surgical execution.

Naviswiss said it will begin marketing the Naviplan software and its navigation platform to U.S. orthopedic care centers by the end of the year.