Conformis Actera™ Hip System Receives 510(k) Clearance from the U.S. Food and Drug Administration

Rhea-AI Summary

Conformis, Inc. (NASDAQ: CFMS) has received FDA 510(k) clearance for the Actera™ Hip System, introducing a tri-taper femoral stem design. This innovative design aims to enhance the direct anterior approach for total hip arthroplasty, minimizing muscle injury and improving surgical outcomes. Conformis plans a limited market release soon, responding to increasing surgeon demand. The Actera system joins a growing portfolio of personalized orthopedic solutions that leverage advanced surgical planning and a Surgery-in-a-Box™ delivery model, enhancing patient care.

Positive

• Received FDA 510(k) clearance for the Actera Hip System, expanding product offerings.
• Introduces a tri-taper femoral stem design, catering to rising surgeon preferences.
• Targeting a growing market for anterior total hip arthroplasty procedures.

Negative

• None.

New design adds increasingly more common tri-taper femoral stem design and direct anterior approaches to the expanding Conformis family of Personalized Total Hip Arthroplasty implants

BILLERICA, Mass., Sept. 13, 2022 (GLOBE NEWSWIRE) -- 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.

Cautionary Statement Regarding Forward-Looking Statements
Statements in this press release about our future expectations, plans and prospects, including statements about the anticipated timing of our product launches, and our financial position and results, total revenue, product revenue, gross margin, operations and growth, as well as other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the forecasts disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual financial results could differ materially from the projections disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our estimates and expectations regarding our revenue, gross margin, expenses, revenue growth and other results of operations, and the other risks and uncertainties described in the "Risk Factors" sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date hereof. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

CONTACT
Investor contact
ir@conformis.com
781.374.5598

Source: Conformis, Inc.

 

FAQ

What is the Actera Hip System by Conformis?

The Actera Hip System is a new total hip arthroplasty system featuring a tri-taper femoral stem design, which has received FDA 510(k) clearance.

What are the benefits of the tri-taper design in the Actera Hip System?

The tri-taper design facilitates a minimally invasive direct anterior surgical approach, potentially reducing muscle damage and improving implant stability.

When will the Actera Hip System be available for use?

Conformis plans to begin a limited market release of the Actera Hip System in select U.S. markets in the coming months.

How does the Actera Hip System fit into Conformis' product portfolio?

The Actera Hip System expands Conformis' portfolio of personalized orthopedic implants, following previous FDA clearances for their Cordera and standard hip systems.