FDA grants 510(k) approval for iTotal Hip replacement system.-ConforMIS, Inc.

ConforMIS, Inc. a medical technology company that offers knee replacement implants customized to fit each patient's unique anatomy announced it has received FDA 510(k) clearance of the Company�s primary iTotal Hip replacement system.This product is aimed for a limited launch in 2019.

The hip replacement system is based on patient specific-technology, using single-use 3D printed instruments, with an implementation system that requires little reusable instruments. Previously, ConforMIS used their patient-specific methods to customize and replace knee implants. This FDA clearance allows an expansion of this system for other joint replacement procedures and encourages a growing trend in personalized treatments.