FDA OKs Conformis’ Identity Imprint Knee Replacement System

Conformis, Inc. earned 510(k) for its 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 orthopedic surgeon customers and patients. 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 allow faster delivery times and intraoperative options more similar to standard knee systems.
 
Identity Imprint uses a proprietary 3D “best-fit” algorithm to select the implant most closely meeting patient geometric and anatomic requirements based on 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,” Mark Augusti, president and CEO told the press. “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.”