FDA Premarket Approval Application Supplement approved 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.  Following more than 20 years of clinical experience and over 300,000 procedures across Canada, Europe, Middle East, Africa, and Asia, the Oxford Cementless Partial Knee is now the only FDA-approved cementless partial knee implant in the U.S.

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."

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.