Conformis Gains FDA Clearance for Identity Imprint Knee Replacement

Conformis was granted FDA 510(k) clearance to market the Identity Imprint™ Knee Replacement.

Identity Imprint is available in cruciate retaining and posterior stabilized versions, and combines pre-determined implant sizes with standard and patient-specific surgical instrumentation. Identity Imprint can provide faster delivery times and intraoperative options that are more similar to standard knee systems.

Identity Imprint uses a proprietary 3D “best-fit” algorithm to choose the implant that most closely meets the geometric and anatomic requirements of the patient, based on CT scans. The system will be delivered using Conformis’ sterile “surgery-in-box” system, which is expected to provide ASCs with greater procedural efficiency and improved sterilization cost savings than standard systems.

Mark Augusti, President and CEO, 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. 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.”