ConforMIS Receives FDA 510(k) Clearance for iTotal Hip

By Julie A. Vetalice

ConforMIS (CFMS) received FDA 510(k) clearance of the iTotal Hip replacement system. Limited launch is slated for 2019. (Update, 8/7/17: launch has been accelerated to 2H18, per leadership)

iTotal Hip is supported by iFit "Image-to-Implant" technology to develop and manufacture cutting jigs and implants, similar to what is used to design CFMS' customized knee implants; iTotal also employs single-use 3D printed instruments and a just-in-time delivery model.

Originally, the company had submitted the hip application in 2015, but in light of an inability to address FDA's review questions within an allowed review timeframe, CFMS elected to withdraw the application in early 2Q16. The new application was submitted in 2H16.

Sources: ConforMIS, Inc.; ORTHOWORLD Inc.

Product Labels: Hip Replacement

Tags: 510(k) Clearance, Regulatory