CFMS - Conformis wins FDA clearance for Identity Imprint Knee Replacement System

Conformis ([[CFMS]] +9.2%) announced that the FDA has granted the 510(k) clearance for the Company’s Identity Imprint Knee Replacement System.Unlike its iTotal Identity knee replacement system which is designed for each patient, Identity Imprint combines pre-defined implant sizes with standard and patient-specific surgical instrumentation, the company said.“We will be able to provide a patient-matched Identity Imprint system in 3 weeks versus the six weeks lead time for the iTotal Identity fully personalized system,” noted Conformis CEO, Mark Augusti.“This offering is extremely well-positioned to meet the needs of the ASC care setting but will provide value to in-patient hospital care as well, especially in the post-COVID environment” Augusti explained.Driven by a growing number of procedures in ASC and outpatient settings, nearly 1M knee replacements are expected to be performed in the U.S. this year.In March, cited an independent, retrospective review of hospital data, Conformis highlighted the cost-effectiveness of its iTotal knee replacement technology.

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Conformis wins FDA clearance for Identity Imprint Knee Replacement System