Conformis Announces 510(k) Clearance for iTotal® Identity PS
iTotal® Identity PS joins iTotal® Identity CR as the latest personalized knee technology from Conformis
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.
About Conformis, Inc.
Conformis is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture, and sell joint replacement implants and instruments that are individually sized and shaped, which we refer to as personalized, individualized, or sometimes as customized, to fit and conform to each patient’s unique anatomy. Conformis offers a broad line of sterile, personalized knee and hip implants and single-use instruments delivered to hospitals. In clinical studies, the Conformis iTotal CR knee replacement system demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. Conformis owns or exclusively in-licenses issued patents and pending patent applications that cover personalized implants and patient-specific instrumentation for all major joints.
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New Clinical Study Finds Bilateral Knee Patients Prefer Conformis’ Fully Personalized Solution Over Competitive Off-the-Shelf Implants by a Factor of Over 10 to 1
Study included only patients with a fully personalized Conformis implant in one knee after previously receiving a competitive off-the-shelf implant
Conformis iTotal® CR Knee Replacement System Awarded “7A” Performance Rating from the U.K.’s Orthopaedic Data Evaluation Panel
Independently verified assessment of the performance of the fully personalized iTotal CR system over a 7-year period confirms that it meets the panel’s demanding standards