Conformis announces FDA 510(k) clearance of personalized TKR system
Click Here to Manage Email Alerts
Conformis Inc. has announced FDA 510(k) clearance of the Identity Imprint total knee replacement system, according to a press release.
The system, which is available in cruciate retaining and posterior stabilized versions, is designed for pre-determined implant sizes combined with standard and patient-specific surgical instrumentation for a more efficient intraoperative experience, according to the release.
“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 vs. the 6 weeks lead time for the iTotal Identity fully personalized system,” Mark Augusti, president and CEO of Conformis, said in the release. “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.”
Read more about
Click Here to Manage Email Alerts