Zimmer Biomet announced FDA Premarket Approval Application (PMA) Supplement approval for the Oxford Cementless Partial Knee. The approval is based on safety and effectiveness data from an Investigational Device Exemption (IDE) study and non-clinical testing for cementless partial knee replacement (PKR). The Oxford Cementless Partial Knee allows surgeons to perform a PKR with improved fixation, better long-term implant survival rate and improved efficiency in the operating room (OR) compared to the Oxford Cemented Partial Knee procedure. The company said the Oxford Cementless Partial Knee is now the only FDA-approved cementless partial knee implant in the U.S.
Compared to traditional partial knee replacements that use bone cement to secure the implant in place, a cementless approach allows patients' natural bone growth to secure the implant for better long-term fixation. The Oxford Cementless Partial Knee features a mobile bearing that can move with the femoral component throughout the entire range of motion to mimic natural knee movement. This design provides better range of motion, a more natural feel and a more stable implant-to-bone fixation for improved long-term implant survival. The system's tibial and femoral components have a titanium and hydroxyapatite coating to promote bone growth into the implant. The UK national joint registry has more than 33,000 patients treated with Oxford Cementless Partial Knees recorded with a 94.1% rate of implant survival at 10 years after surgery, which is higher than the average 10-year survivorship for all other partial knees (89.9%). Enthusiasm and usage of partial knee replacement continues to grow around the world as published research continues to demonstrate that PKR in appropriate cases provides improved patient outcomes compared to TKR.
Since its initial launch in England in 2004, the Oxford Cementless Partial Knee has become the preferred partial knee implant for Zimmer Biomet's European customers.
As part of the U.S. nationwide launch in the first quarter of 2025, Zimmer Biomet will provide FDA-required training, focusing on the cementless surgical technique and proper patient selection. For patients in the U.S., the Oxford Partial Knee is the only implant with a lifetime limited warranty that covers the cost of Zimmer Biomet replacement implants.
