Conformis (NSDQ:CFMS)Conformis today said it received FDA 510(k) clearance for its iTotal Identity PS Knee System.
The system uses advanced imaging and design software to help deliver patient-specific pre-operative surgical plans with a comprehensive set of iJig instruments and patient-matched implants. The system updates features stem extensions available for patients with high body mass index, titanium tibial base plates with patient-specific cement rails and metal cut guides and refined iJigs for a traditional bone cutting experience.
“Our new iTotal Identity PS knee is an important addition to our total knee portfolios. Having a Posterior Stabilized (PS) option for our Identity system will allow surgeons to treat a wider range of patients more effectively and with greater confidence than ever before,” president and CEO Mark Augusti said in a news release. “We remain the leader in bringing best-in-class PSI guides in a market-leading, efficient ‘knee-in-a-box’ model to the orthopedic surgeons.”
Conformis recently settled a patent dispute with Zimmer Biomet over the company’s knee and hip replacement products. The two companies agreed to cross-license their respective technologies and Zimmer Biomet would pay Conformis $9.6 million by January 15, 2021.