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.”