Conformis Gains FDA Clearance for iTotal Identity PS

By Julie A. Vetalice

Conformis Gains FDA Clearance for iTotal Identity PS

Conformis received FDA 510(k) clearance to market the next generation iTotal® Identity PS Knee System.

iTotal Identity PS uses proprietary imaging and design software to deliver a patient-specific, pre-operative surgical plan with iJig instruments and patient-matched implants. Updates to this system include stem extensions for patients with high Body Mass Index, titanium tibial baseplates with patient-specific cement rails and metal cut guides and refined iJigs for a more traditional bone cutting experience.

“Our new iTotal Identity PS knee is an important addition to our total knee portfolios. Having a Posterior Stabilized (PS) option for our Identity system will allow surgeons to treat a wider range of patients more effectively and with greater confidence than ever before,” said Mark Augusti, President and CEO. “We remain the leader in bringing best-in-class PSI guides in a market-leading, efficient 'knee-in-a-box' model to the orthopedic surgeons.”

Product Labels: Knee Replacement

Tags: 510(k) Clearance, Regulatory