Conformis Gains FDA Clearance for Identity Imprint Knee Replacement

By Julie A. Vetalice

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.”

Product Labels: Knee Replacement

Tags: 510(k) Clearance, Regulatory