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Conformis Announces 510(k) Clearance For iTotal Identity PS

BILLERICA, Mass., June 22, 2020 (GLOBE NEWSWIRE) -- Conformis, Inc. (NASDAQ:CFMS) today announced 510(k) clearance by the U.S. Food and Drug Administration of the Company’s next generation iTotal® Identity

Benzinga · -

BILLERICA, Mass., June 22, 2020 (GLOBE NEWSWIRE) -- Conformis, Inc. (NASDAQ:CFMS) today announced 510(k) clearance by the U.S. Food and Drug Administration of the Company’s next generation iTotal® Identity PS Knee System.

The iTotal® Identity PS Knee System uses proprietary advanced imaging and design software, to deliver a patient-specific, pre-operative surgical plan with a comprehensive set of iJig instruments and patient-matched implants.  Updates to this system include stem extensions available for patients with high Body Mass Index (BMI), 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 of Conformis, Inc. “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.”

The global knee joint reconstruction market is projected at over $9 billion, with approximately 1 million knee replacements projected to be performed in the United States this year.