Conformis Actera™ Hip System Receives 510(k) Clearance from the U.S. Food and Drug Administration
September 13 2022 - 4:30PM
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.
About Conformis, Inc.Founded in
2004, Conformis is a medical technology company focused on
advancing orthopedic patient care and creating a world without
joint pain. Its product portfolio is designed to maximize surgeon
and patient choice by offering fully personalized solutions through
its Image-to-Implant® Platinum Services℠ Program as well as
data-informed, standardized solutions that combine many benefits of
personalization with the convenience and flexibility of an
off-the-shelf system. Conformis’ sterile, just-in-time,
Surgery-in-a-Box™ delivery system is available with all of its
implants and personalized, single-use instruments. Conformis owns
or exclusively in-licenses issued patents and pending patent
applications that cover personalized implants and patient-specific
instrumentation for all major joints. For more information, visit
www.conformis.com. To receive future press releases via e-mail
alerts, sign up at ir.conformis.com.
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CONTACTInvestor
contactir@conformis.com781.374.5598
Source: Conformis, Inc.
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