Zimmer Biomet has received US Food and Drug Administration (FDA) premarket approval application (PMA) supplement approval for the Oxford Cementless Partial Knee implant.
The approval makes the implant the only cementless partial knee replacement (PKR) implant available in the US. It is based on the safety and effectiveness data from an investigational device exemption (IDE) study and non-clinical testing.
According to Zimmer Biomet, the Oxford Cementless Partial Knee offers improved fixation, long-term implant survival, and increased operating room (OR) efficiency compared to the Oxford Cemented Partial Knee procedure.
Zimmer Biomet knees president Joe Urban said: “Cementless knee replacement procedures are increasingly preferred by surgeons seeking to improve surgical efficiency.
“The Oxford Cementless Partial Knee is coming into the US 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.
“We are excited to address the unmet US demand for a cementless partial knee with a new offering which has 20 years of clinical experience in more than 50 countries.”
Zimmer Biomet said that the cementless approach allows natural bone growth to secure the implant for better long-term fixation, unlike traditional partial knee replacements that rely on bone cement.
The Oxford Cementless Partial Knee implant features a mobile bearing that moves with the femoral component throughout the complete range of motion to mimic natural knee movement. This design enhances the range of motion, offers a more natural feel, and provides more stable implant-to-bone fixation for improved long-term survival.
The tibial and femoral components are coated with titanium and hydroxyapatite to promote bone growth in the implant.
Since its launch in England in 2004, the Oxford Cementless Partial Knee has been available for Zimmer Biomet’s European customers.
As part of the US launch in Q1 2025, the medical technology company will offer FDA-required training on the cementless surgical technique and proper patient selection. The offering will be backed by a lifetime limited warranty covering the cost of Zimmer Biomet replacement implants.
Recently, the implant maker received the CE mark for its Persona Revision Knee System.
