Conformis Granted 510(k) Clearance for Cordera Hip

By Julie A. Vetalice

Conformis Granted 510(k) Clearance for Cordera Hip

Conformis received FDA 510(k) clearance to market the Cordera™ Hip System.

Cordera is an uncemented hip replacement comprising femoral and acetabular components. It can be used with or without a pre-operative CT scan to design Conformis iJigs® and a personalized surgical plan. All components are delivered sterile to hospitals and ambulatory surgery centers.

Cordera is indicated for use in total and revision hip replacement.

“Our new Cordera™ Hip System is the first expansion of our growing total hip portfolio. The system, which is inserted using an anterior or posterior surgical approach, will allow surgeons to treat a wider range of patients effectively,” said Mark Augusti, President and CEO. “And surgeons have the option to select an accompanying personalized surgical plan and best in class PSI guides provided through a safe, sterile, and efficient model for hospitals and ambulatory surgery center sites of care.”

The first product in Conformis' hip line launched commercially in November 2019 and provided a patient-specific stem.

Product Labels: Hip Replacement

Tags: 510(k) Clearance, Regulatory