Today, Zimmer Biomet (NYSE:ZBH) revealed that it has received a supplementary premarket approval (PMA) from the FDA for its Oxford non-cemented partial knee replacement system. This innovation enables surgeons to carry out partial knee replacements (PKR) with enhanced fixation, superior long-term implant durability, and increased efficiency compared to the Oxford version that uses a cemented method. The approval is underpinned by safety and efficacy results from an FDA investigational device exemption (IDE) study and supplementary non-clinical evaluations for the cementless PKR.
The non-cemented system boasts two decades of clinical application and has been employed in over 300,000 surgeries globally. Zimmer Biomet proudly states that it is now the sole provider in the U.S. accredited by the FDA for a cementless partial knee implant.
In traditional PKR, bone cement is utilized to anchor the implant. Contrarily, a cementless method allows for natural bone integration, resulting in better long-term fixation, according to the company. The standout feature of the Oxford non-cemented partial knee is its mobile bearing, which aligns with the femoral component throughout the complete range of motion. This simulates natural knee movement, offering an improved motion range and a more authentic feel. Additionally, it supports a stable implant-to-bone connection, enhancing the long-term survival of the implant.
Zimmer Biomet’s system integrates tibial and femoral components coated with titanium and hydroxyapatite, which stimulate bone ingrowth into the implant, as highlighted in the company’s statement.
The organization is planning a broad U.S. market introduction of this system in the first quarter of 2025.
“Surgeons are increasingly opting for cementless knee replacement techniques to improve surgical efficiency,” commented Joe Urban, Knees President at Zimmer Biomet. “The Oxford cementless partial knee is entering the U.S. market backed by a robust history of maintaining more healthy tissue through less intrusive methods and yielding better outcomes compared to total knee replacements. We are eager to meet the U.S. demand for a cementless partial knee by providing a new option that carries 20 years of clinical expertise in more than 50 nations.”