Conformis, Inc. (NASDAQ:CFMS) today announced 510(k) clearance by the U.S. Food and Drug Administration for the Company's Identity Imprint Knee Replacement System.
Identity Imprint is a new total knee replacement system, available in both cruciate retaining (CR) and posterior stabilized (PS) versions, that expands the range of options open to Conformis' orthopedic surgeon customers and their patients. Whereas the Conformis iTotal® Identity knee replacement system is designed and manufactured individually to fit the unique size, shape, and curvature of each patient's anatomy, Identity Imprint combines pre-determined implant sizes with standard and patient-specific surgical instrumentation. Identity Imprint will provide surgeons with faster delivery times and intraoperative options that are more similar to standard knee systems.
Identity Imprint utilizes a proprietary 3-dimensional (3D) "best-fit" algorithm to select the implant that most closely meets the geometric and anatomic requirements of the patient based on the patient's computed tomography (CT) scans. The Identity Imprint will be delivered using Conformis' sterile "surgery-in-box" system, which is expected to provide ambulatory surgical centers (ASCs) greater procedural efficiency and improved sterilization cost savings than standard systems.
"Our Identity Imprint knee system is a tremendous new addition to our product portfolio that leverages our technical innovations and data from tens of thousands of personalized implant designs. It is a terrific option for those surgeons who want more traditional intraoperative flexibility and faster product availability. 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," said Mark Augusti, President and CEO. "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. Importantly, it also provides surgeons and their patients a new choice among Conformis' world-class treatment options."
The global knee joint reconstruction market is projected at over $9 billion, with approximately 1 million knee replacements expected to be performed in the United States this year, with a growing number of knee procedures to be performed in the ASC and outpatient settings.