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Conformis Actera Hip System Receives 510(k) Clearance From The U.S. FDA

Conformis, Inc. (NASDAQ:CFMS), a leading medical technology company featuring personalized knee and hip replacement products, today announced that it has received 510(k) clearance from the U.S. Food and Drug

Benzinga · 09/13/2022 16:30

Conformis, Inc. (NASDAQ:CFMS), a leading medical technology company featuring personalized knee and hip replacement products, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for the Company’s Actera™ Hip System.

Actera adds a tri-taper femoral stem design to the expanding Conformis hip portfolio. This advanced tri-taper design is becoming more common among orthopedic surgeons, as its design objective is to facilitate a minimally invasive approach similar to direct anterior, with easier access to the femur and consequently less injury to muscles and fewer potential interactions with nerves.

“We’re excited to expand Conformis’ hip portfolio with the addition of Actera, to satisfy the rise in surgeon demand for tri-taper stems,” said Mark Augusti, Chief Executive Officer and President of Conformis. “Surgeons have demonstrated a significant and growing preference for anterior total hip arthroplasty (THA) surgeries in recent years, and the innovative tri-taper stem is designed for easier placement. Peer-reviewed studies provide an increasing body of evidence that a tri-taper stem supports improved proximal load transfer and lower likelihood of implant loosening.”

Conformis will introduce the Actera hip system under a limited market release in select U.S. markets, which is expected to commence in the coming months. This complete THA system and supporting software has been developed to offer more personalized alternatives to cementless hip stems on market, while leveraging the Company’s advanced surgical planning and surgery in a box delivery model.

“The Actera hip, with its tri-tapered stem, is the natural evolution of the Conformis personalized portfolio,” said Dr. Robert T. Trousdale, M.D., a Board-certified orthopedic surgeon at the Mayo Clinic in Rochester, MN. “It is well-suited to whichever surgical approach is chosen by the surgeon.”

Chronology of the Conformis Hip Portfolio:

  • Conformis Actera™ Hip System: The Conformis Actera Hip System received FDA 510(k) marketing clearance in 2022. It utilizes an advanced tri-taper femur stem design that facilitates direct anterior approach total hip arthroplasties, and provides an additional stem option to orthopedic surgeons.
  • Conformis Cordera™ Hip System: The Conformis Cordera Hip System received FDA 510(k) marketing clearance in 2020. It is a cementless 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.
  • Conformis Hip System: The Conformis Hip System received FDA 510(k) marketing clearance in 2019. The Conformis Hip System is the only primary total hip replacement system on the market designed with 3D imaging technology to provide a stem and acetabular cup size that matches each patient’s specific anatomy.