Conformis Announces 510(k) Clearance for Cordera Hip System
Conformis, Inc. today announced 510(k) clearance by the U.S. Food and Drug Administration of the Company’s new Cordera Hip System. The first product in the Conformis hip product line, the Conformis Hip System, was launched commercially in November 2019 and provided a patient-specific stem.
The Cordera Hip System is an uncemented, primary total hip replacement composed of femoral (thigh) and acetabular (socket of the hip bone) components. The system can be used with or without a pre-operative CT scan that is used to design Conformis iJigs (patient-specific instruments) and a personalized surgical plan. All components are delivered sterile to hospitals and ambulatory surgery centers (ASCs).
The Cordera™ Hip System is indicated for use in total hip replacement due to:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis (death of bone tissue due to a lack of blood supply), or congenital hip dysplasia (where the socket of the hip joint does not fully support the ball of the joint).
- Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- Revision procedures for failed previous hip surgery (excluding situations where hardware is present).
“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 global hip joint reconstruction market is projected to be more than $8 billion, with nearly 500,000 hip replacements to be performed in the United States next year.
About Conformis, Inc.
Conformis is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture, and sell joint replacement implants and instruments that are individually sized and shaped, which we refer to as personalized, individualized, or sometimes as customized, to fit and conform to each patient’s unique anatomy. Conformis offers a broad line of sterile, personalized knee and hip implants and single-use instruments delivered to hospitals. In clinical studies, the Conformis iTotal CR knee replacement system demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. Conformis owns or exclusively in-licenses issued patents and pending patent applications that cover personalized implants and patient-specific instrumentation for all major joints.
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