Conformis (NSDQ:CFMS) recently announced that it received FDA 510(k) clearance for its Cordera Hip System.
The hip system is an uncemented, primary total hip replacement that features femoral and acetabular components. It can be used with or without a pre-operative CT scan that is used to design Conformis patient-specific instruments with a personalized surgical plan.
“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,” president and CEO Mark Augusti said in a news release. “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.”
Cordera is intended for use in total hip replacement due to a disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or congenital hip dysplasia. It is also used to treat non-displaced non-unions of the hip, femoral neck fractures and trochanterix fractures of the proximal femur with head involvement, unmanageable by other techniques.
