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Home » Zimmer Biomet wins FDA nod for cementless partial knee

Zimmer Biomet wins FDA nod for cementless partial knee

November 26, 2024 By Sean Whooley

Zimmer Biomet Oxford Cementless Partial Knee
The Oxford cementless partial knee. [Image from Zimmer Biomet]
Zimmer Biomet (NYSE:ZBH) announced today that it received supplemental FDA premarket approval (PMA) for its Oxford cementless partial knee.

Oxford allows surgeons to perform partial knee replacement (PKR) with improved fixation, better long-term implant survival and improved efficiency compared to the Oxford cemented partial knee procedure. Approval came on the back of safety and effectiveness data from an FDA investigational device exemption (IDE) study and non-clinical testing for cementless PKR.

The cementless system brings 20 years of clinical experience and more than 300,000 procedures around the world. Zimmer Biomet said it’s now the only FDA-approved cementless partial knee implant in the U.S.

Traditional PKR uses bone cement to secure the implant in place. A cementless approach allows natural bone growth to secure the implant for better long-term fixation, the company says. The Oxford cementless partial knee features a mobile bearing that can move with the femoral component through the entire range of motion. This mimics natural knee movement for a better range of motion and a more natural feel. It also enables a more stable implant-to-bone fixation for improved long-term implant survival.

Zimmer Biomet said the system’s tibial and femoral components have a titanium and hydroxyapatite coating. This promotes bone growth into the implant, the company said in a news release.

The company plans to begin a nationwide launch in the U.S. in the first quarter of 2025.

“Cementless knee replacement procedures are increasingly preferred by surgeons seeking to improve surgical efficiency. 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,” said Joe Urban, president, Knees at Zimmer Biomet. “We are excited to address the unmet U.S. demand for a cementless partial knee with a new offering which has 20 years of clinical experience in more than 50 countries.”

Filed Under: Food & Drug Administration (FDA), Implants, Orthopedic Implants, Orthopedics, Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: FDA, Zimmer Biomet

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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