News

Zimmer Biomet Gains FDA Approval, Brings First Cementless Partial Knee Replacement Implant to the U.S.

• By John K. Waters
• 12/02/2024

Zimmer Biomet Holdings, a global medical technology company that designs, manufactures, and sells products and services for musculoskeletal healthcare, has received FDA approval for its Oxford Cementless Partial Knee, the company said this week, marking the introduction of the first cementless partial knee replacement implant in the U.S. The approval, granted through a Premarket Approval Application (PMA) Supplement, is based on data from clinical studies and non-clinical testing, the company announced.

Unlike traditional knee replacement implants that rely on bone cement for fixation, the Oxford Cementless Partial Knee uses the patient’s natural bone growth to secure the implant. According to Zimmer Biomet, this approach offers improved fixation, longer implant survival rates, and enhanced efficiency during surgery compared to its cemented counterpart.

The implant’s design includes a mobile bearing to mimic natural knee movement and a titanium and hydroxyapatite coating to promote bone integration. These features aim to provide a more natural range of motion and greater long-term stability. Data from the UK National Joint Registry indicates a 94.1% implant survival rate at 10 years for the Oxford Cementless Partial Knee, outperforming the average 89.9% for other partial knees.

"Cementless knee replacement procedures are increasingly preferred by surgeons seeking to improve surgical efficiency," said Joe Urban, President, Knees at Zimmer Biomet, in a statement . "The Oxford Cementless Partial Knee is coming into the U.S. with a proven track record of retaining more healthy anatomy with a less invasive approach and improved outcomes as compared to a total knee replacement."

The implant is particularly suited for younger, active patients and those with osteoarthritis or avascular necrosis confined to the medial knee compartment, the company says. However, it is not indicated for patients with ligament deficiencies or those requiring bilateral knee procedures.

"For younger and more active patients, the Oxford Cementless Partial Knee amplifies the benefits of a traditional partial knee replacement by offering knee flexion that resembles natural knee movement, and stronger adhesion of the implant to the bone for better long-term durability," said Adolph V. Lombardi Jr., MD, President of JIS Orthopedics in New Albany, in a statement. "In my own practice, a cementless approach has increased OR efficiency by shortening my surgery time and reducing costs associated with cement preparation."

Zimmer Biomet plans a nationwide rollout of the implant in early 2025, along with FDA-mandated training for surgeons on proper patient selection and surgical techniques.